NCT06528314

Brief Summary

This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with compensated cirrhosis due to NASH/MASH.

Trial Health

88
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
2,150

participants targeted

Target at P75+ for phase_3

Timeline
47mo left

Started Sep 2024

Longer than P75 for phase_3

Geographic Reach
19 countries

318 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress30%
Sep 2024Mar 2030

First Submitted

Initial submission to the registry

June 28, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 30, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

September 4, 2024

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2030

Expected
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2030

Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

5.4 years

First QC Date

June 28, 2024

Last Update Submit

April 21, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Time from randomization to the first significant clinical event including disease progression, liver decompensation events, etc.

    Measured by composite of protocol-specified clinical events

    5 years

  • Cohort 1 only: Proportion of subjects with ≥ 1 stage improvement in fibrosis and no worsening of steatohepatitis

    Based on NASH CRN fibrosis score (scored by a fibrosis score of 0-4, where 0 = no fibrosis, 1 = centrilobular pericellular fibrosis, 2 = centrilobular and periportal fibrosis, 3 = bridging fibrosis, 4 = cirrhosis)

    96 Weeks

Secondary Outcomes (19)

  • Change from baseline of non-invasive markers of liver fibrosis

    96 Weeks, 5 Years

  • Change from baseline of non-invasive markers of liver fibrosis

    96 Weeks, 5 Years

  • Change from baseline of non-invasive markers of liver fibrosis

    96 Weeks, 5 Years

  • Change from baseline of markers of liver injury

    96 Weeks, 5 Years

  • Change from baseline of lipoproteins

    96 Weeks, 5 Years

  • +14 more secondary outcomes

Study Arms (2)

EFX 50 mg

EXPERIMENTAL
Drug: Efruxifermin

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Administered by subcutaneous injection

EFX 50 mg

Administered by subcutaneous injection

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cohort 1: Biopsy proven compensated cirrhosis (fibrosis stage 4) due to NASH/MASH and NAS score of \>=3 (at least 1 in each category) or evidence of steatosis and 2 current features of metabolic comorbidities
  • Cohort 2: Biopsy proven or non-invasively diagnosed compensated cirrhosis (fibrosis stage 4) due to NASH/MASH

You may not qualify if:

  • Other causes of liver disease based on medical history and/or liver histology and/or central laboratory results
  • Type 1 diabetes or unstable Type 2 diabetes
  • Any current or prior history of decompensated liver disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (318)

Akero Clinical Study Site

Birmingham, Alabama, 35209, United States

RECRUITING

Akero Clinical Study Site

Dothan, Alabama, 36301, United States

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Akero Clinical Study Site

Chandler, Arizona, 85224, United States

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Akero Clinical Study Site

Flagstaff, Arizona, 86001, United States

ACTIVE NOT RECRUITING

Akero Clinical Study Site

Peoria, Arizona, 85381, United States

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Akero Clinical Study Site

Scottsdale, Arizona, 85258, United States

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Akero Clinical Study Site

Tucson, Arizona, 85712, United States

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Akero Clinical Study Site

Tucson, Arizona, 85712, United States

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Akero Clinical Study Site

Tucson, Arizona, 85713, United States

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Akero Clinical Study Site

Tucson, Arizona, 85715, United States

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Akero Clinical Study Site

Conway, Arkansas, 72032, United States

ACTIVE NOT RECRUITING

Akero Clinical Study Site

Jonesboro, Arkansas, 72401, United States

ACTIVE NOT RECRUITING

Akero Clinical Study Site

Little Rock, Arkansas, 72205, United States

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Akero Clinical Study Site

North Little Rock, Arkansas, 72117, United States

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Akero Clinical Study Site

Coronado, California, 92118, United States

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Akero Clinical Study Site

Escondido, California, 92025, United States

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Akero Clinical Study Site

Folsom, California, 95630, United States

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Akero Clinical Study Site

Lancaster, California, 93534, United States

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Akero Clinical Study Site

Long Beach, California, 90815, United States

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Akero Clinical Study Site

Los Angeles, California, 90048, United States

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Akero Clinical Study Site

Newport Beach, California, 92663, United States

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Akero Clinical Study Site

Orange, California, 92868, United States

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Akero Clinical Study Site

Pasadena, California, 91105, United States

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Akero Clinical Study Site

Redwood City, California, 94063, United States

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Akero Clinical Study Site

Sacramento, California, 95817, United States

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Akero Clinical Study Site

San Francisco, California, 94115, United States

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Akero Clinical Study Site

San Francisco, California, 94117, United States

ACTIVE NOT RECRUITING

Akero Clinical Study Site

San Jose, California, 95116, United States

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Akero Clinical Study Site

Tarzana, California, 91356, United States

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Akero Clinical Study Site

Aurora, Colorado, 80045, United States

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Akero Clinical Study Site

Colorado Springs, Colorado, 80907, United States

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Akero Clinical Study Site

Englewood, Colorado, 80113, United States

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Akero Clinical Study Site

New Haven, Connecticut, 06511, United States

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Akero Clinical Study Site

Washington D.C., District of Columbia, 20422, United States

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Akero Clinical Study Site

Bradenton, Florida, 34208, United States

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Akero Clinical Study Site

Brandon, Florida, 33511, United States

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Akero Clinical Study Site

Cutler Bay, Florida, 33189, United States

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Akero Clinical Study Site

Doral, Florida, 33126, United States

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Akero Clinical Study Site

Fort Myers, Florida, 33912, United States

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Akero Clinical Study Site

Hialeah Gardens, Florida, 33016, United States

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Akero Clinical Study Site

Inverness, Florida, 34452, United States

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Akero Clinical Study Site

Lakewood Rch, Florida, 34211, United States

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Akero Clinical Study Site

Largo, Florida, 33777, United States

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Akero Clinical Study Site

Lehigh Acres, Florida, 33936, United States

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Akero Clinical Study Site

Margate, Florida, 33063, United States

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Akero Clinical Study Site

Miami, Florida, 33136, United States

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Akero Clinical Study Site

Miami, Florida, 33175, United States

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Akero Clinical Study Site

Miami Gardens, Florida, 33014, United States

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Akero Clinical Study Site

Naples, Florida, 34102, United States

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Akero Clinical Study Site

New Port Richey, Florida, 34653, United States

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Akero Clinical Study Site

Ocala, Florida, 34471, United States

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Akero Clinical Study Site

Orlando, Florida, 32806, United States

ACTIVE NOT RECRUITING

Akero Clinical Study Site

Orlando, Florida, 32807, United States

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Akero Clinical Study Site

Pembroke Pines, Florida, 33027, United States

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Akero Clinical Study Site

Riverview, Florida, 33578, United States

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Akero Clinical Study Site

Sarasota, Florida, 34240, United States

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Akero Clinical Study Site

Temple Terrace, Florida, 33617, United States

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Akero Clinical Study Site

Venice, Florida, 34285, United States

ACTIVE NOT RECRUITING

Akero Clinical Study Site

Viera, Florida, 32940, United States

ACTIVE NOT RECRUITING

Akero Clinical Study Site

Weston, Florida, 33331, United States

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Akero Clinical Study Site

Zephyrhills, Florida, 33542, United States

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Akero Clinical Study Site

Atlanta, Georgia, 30309, United States

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Akero Clinical Study Site

Gainesville, Georgia, 30501, United States

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Akero Clinical Study Site

Marietta, Georgia, 30060, United States

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Akero Clinical Study Site

Snellville, Georgia, 30078, United States

ACTIVE NOT RECRUITING

Akero Clinical Study Site

Chicago, Illinois, 60611, United States

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Akero Clinical Study Site

Hammond, Indiana, 46324, United States

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Akero Clinical Study Site

Indianapolis, Indiana, 46202, United States

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Akero Clinical Study Site

South Bend, Indiana, 46635, United States

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Akero Clinical Study Site

West Des Moines, Iowa, 50265, United States

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Akero Clinical Study Site

Topeka, Kansas, 66606, United States

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Akero Clinical Study Site

Louisville, Kentucky, 40202, United States

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Akero Clinical Study Site

Bastrop, Louisiana, 71220, United States

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Akero Clinical Study Site

Covington, Louisiana, 70433, United States

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Akero Clinical Study Site

Houma, Louisiana, 70363, United States

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Akero Clinical Study Site

Lafayette, Louisiana, 70503, United States

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Akero Clinical Study Site

Marrero, Louisiana, 70072, United States

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Akero Clinical Study Site

Metairie, Louisiana, 70006, United States

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Akero Clinical Study Site

Shreveport, Louisiana, 71105, United States

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Akero Clinical Study Site

West Monroe, Louisiana, 71291, United States

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Akero Clinical Study Site

Baltimore, Maryland, 21202, United States

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Akero Clinical Study Site

Bethesda, Maryland, 20889-0004, United States

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Akero Clinical Study Site

Russells Mills, Massachusetts, 02747, United States

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Akero Clinical Study Site

Clinton Township, Michigan, 48038, United States

ACTIVE NOT RECRUITING

Akero Clinical Study Site

Novi, Michigan, 48377, United States

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Akero Clinical Study Site

Southfield, Michigan, 48075, United States

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Akero Clinical Study Site

Rochester, Minnesota, 55905, United States

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Akero Clinical Study Site

Flowood, Mississippi, 39232, United States

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Akero Clinical Study Site

Columbia, Missouri, 65201, United States

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Akero Clinical Study Site

Kansas City, Missouri, 64131, United States

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Akero Clinical Study Site

St Louis, Missouri, 63110, United States

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Akero Clinical Study Site

St Louis, Missouri, 63123, United States

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Akero Clinical Study Site

Las Vegas, Nevada, 89106, United States

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Akero Clinical Study Site

Jackson, New Jersey, 08527, United States

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Akero Clinical Study Site

Somers Point, New Jersey, 08244, United States

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Akero Clinical Study Site

Sparta, New Jersey, 07871, United States

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Akero Clinical Study Site

Buffalo, New York, 14203, United States

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Akero Clinical Study Site

Manhasset, New York, 11030, United States

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Akero Clinical Study Site

New York, New York, 10016, United States

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Akero Clinical Study Site

New York, New York, 10021, United States

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Akero Clinical Study Site

New York, New York, 10029, United States

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Akero Clinical Study Site

Rochester, New York, 14642, United States

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Akero Clinical Study Site

Chapel Hill, North Carolina, 27516, United States

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Akero Clinical Study Site

Charlotte, North Carolina, 28204, United States

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Akero Clinical Study Site

Charlotte, North Carolina, 28207, United States

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Akero Clinical Study Site

Durham, North Carolina, 27710, United States

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Akero Clinical Study Site

Fayetteville, North Carolina, 28304, United States

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Akero Clinical Study Site

Morehead City, North Carolina, 28557, United States

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Akero Clinical Study Site

Raleigh, North Carolina, 27612, United States

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Akero Clinical Study Site

Statesville, North Carolina, 28625, United States

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Akero Clinical Study Site

Akron, Ohio, 44320, United States

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Akero Clinical Study Site

Springboro, Ohio, 45066, United States

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Akero Clinical Study Site

Westlake, Ohio, 44145, United States

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Akero Clinical Study Site

Oklahoma City, Oklahoma, 73112, United States

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Akero Clinical Study Site

Hershey, Pennsylvania, 17033, United States

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Akero Clinical Study Site

Philadelphia, Pennsylvania, 19104, United States

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Akero Clinical Study Site

Philadelphia, Pennsylvania, 19107, United States

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Akero Clinical Study Site

Pittsburgh, Pennsylvania, 15213, United States

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Akero Clinical Study Site

Charleston, South Carolina, 29425, United States

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Akero Clinical Study Site

Columbia, South Carolina, 29204, United States

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Akero Clinical Study Site

Summerville, South Carolina, 29485, United States

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Akero Clinical Study Site

Clarksville, Tennessee, 37040, United States

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Akero Clinical Study Site

Hermitage, Tennessee, 37076, United States

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Akero Clinical Study Site

Nashville, Tennessee, 37211, United States

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Akero Clinical Study Site

Amarillo, Texas, 79106, United States

ACTIVE NOT RECRUITING

Akero Clinical Study Site

Austin, Texas, 78745, United States

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Akero Clinical Study Site

Austin, Texas, 78757, United States

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Akero Clinical Study Site

Austin, Texas, 78757, United States

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Akero Clinical Study Site

Bellaire, Texas, 77401, United States

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Akero Clinical Study Site

Brownsville, Texas, 78520, United States

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Akero Clinical Study Site

Corpus Christi, Texas, 78404, United States

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Akero Clinical Study Site

Dallas, Texas, 75203, United States

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Akero Clinical Study Site

Dallas, Texas, 75216, United States

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Akero Clinical Study Site

Dallas, Texas, 75234, United States

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Akero Clinical Study Site

Dallas, Texas, 75246, United States

ACTIVE NOT RECRUITING

Akero Clinical Study Site

Dallas, Texas, 75390, United States

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Akero Clinical Study Site

Denison, Texas, 75020, United States

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Akero Clinical Study Site

Edinburg, Texas, 78539, United States

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Akero Clinical Study Site

Edinburg, Texas, 78539, United States

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Akero Clinical Study Site

Fort Sam Houston, Texas, 78234, United States

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Akero Clinical Study Site

Fort Worth, Texas, 76104, United States

ACTIVE NOT RECRUITING

Akero Clinical Study Site

Garland, Texas, 75044, United States

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Akero Clinical Study Site

Houston, Texas, 77030, United States

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Akero Clinical Study Site

Houston, Texas, 77030, United States

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Akero Clinical Study Site

Houston, Texas, 77030, United States

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Akero Clinical Study Site

Houston, Texas, 77074, United States

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Akero Clinical Study Site

Houston, Texas, 77079, United States

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Akero Clinical Study Site

Pasadena, Texas, 77505, United States

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Akero Clinical Study Site

Pharr, Texas, 78577, United States

ACTIVE NOT RECRUITING

Akero Clinical Study Site

San Antonio, Texas, 78222, United States

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Akero Clinical Study Site

San Antonio, Texas, 78229, United States

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Akero Clinical Study Site

San Antonio, Texas, 78229, United States

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Akero Clinical Study Site

San Antonio, Texas, 78251, United States

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Akero Clinical Study Site

Sugar Land, Texas, 77478, United States

ACTIVE NOT RECRUITING

Akero Clinical Study Site

Sugar Land, Texas, 77478, United States

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Akero Clinical Study Site

Waco, Texas, 76710, United States

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Akero Clinical Study Site

Waco, Texas, 76712, United States

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Akero Clinical Study Site

Webster, Texas, 77598, United States

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Akero Clinical Study Site

Wichita Falls, Texas, 76301, United States

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Akero Clinical Study Site

Norfolk, Virginia, 23502, United States

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Akero Clinical Study Site

Richmond, Virginia, 23226-1925, United States

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Akero Clinical Study Site

Richmond, Virginia, 23236, United States

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Akero Clinical Study Site

Richmond, Virginia, 23249, United States

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Akero Clinical Study Site

Richmond, Virginia, 23284, United States

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Akero Clinical Study Site

Roanoke, Virginia, 24014, United States

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Akero Clinical Study Site

Seattle, Washington, 98105, United States

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Akero Clinical Study Site

Madison, Wisconsin, 53705, United States

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Akero Clinical Study Site

Buenos Aires, Buenos Aires, C1180AAX, Argentina

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Akero Clinical Study Site

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1056ABI, Argentina

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Akero Clinical Study Site

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1199ABB, Argentina

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Akero Clinical Study Site

La Plata, Buenos Aires, B1902AWL, Argentina

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Akero Clinical Study Site

Ramos Mejía, Buenos Aires, B1704ETD, Argentina

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Akero Clinical Study Site

Buenos Aires, Distrito Federal, C1406EEI, Argentina

ACTIVE NOT RECRUITING

Akero Clinical Study Site

Rosario, Sante Fe, S2002KDT, Argentina

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Akero Clinical Study Site

Broadmeadow, New South Wales, 2292, Australia

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Akero Clinical Study Site

Kingswood, New South Wales, 2747, Australia

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Akero Clinical Study Site

Liverpool, New South Wales, 1871, Australia

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Akero Clinical Study Site

Westmead, New South Wales, 2145, Australia

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Akero Clinical Study Site

Herston, Queensland, 4029, Australia

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Akero Clinical Study Site

Adelaide, South Australia, 5000, Australia

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Akero Clinical Study Site

Box Hill, Victoria, 3128, Australia

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Akero Clinical Study Site

Clayton, Victoria, 3168, Australia

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Akero Clinical Study Site

Epping, Victoria, 3076, Australia

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Akero Clinical Study Site

Heidelberg, Victoria, 3084, Australia

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Akero Clinical Study Site

Melbourne, Victoria, 3004, Australia

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Akero Clinical Study Site

Murdoch, Western Australia, 6150, Australia

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Akero Clinical Study Site

Nedlands, Western Australia, 6009, Australia

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Akero Clinical Study Site

Perth, Western Australia, 6000, Australia

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Akero Clinical Study Site

Brasília, Federal District, 71681-603, Brazil

ACTIVE NOT RECRUITING

Akero Clinical Study Site

Goiânia, Goiás, 74690-900, Brazil

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Akero Clinical Study Site

Belo Horizonte, Minas Gerais, 30220-140, Brazil

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Akero Clinical Study Site

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

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Akero Clinical Study Site

Edmonton, Alberta, T6G 2X8, Canada

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Akero Clinical Study Site

Toronto, Ontario, M5G 2C4, Canada

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Akero Clinical Study Site

Toronto, Ontario, M6H 3M1, Canada

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Akero Clinical Study Site

Vaughan, Ontario, L4L 4Y7, Canada

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Akero Clinical Study Site

Montreal, Quebec, H2X 0A9, Canada

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Akero Clinical Study Site

Terrebonne, Quebec, J7B6B7, Canada

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Akero Clinical Study Site

La Serena, Coquimbo Region, 1700000, Chile

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Akero Clinical Study Site

Las Condes, Santiago Metropolitan, 7500000, Chile

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Akero Clinical Study Site

Santiago, Santiago Metropolitan, 8320000, Chile

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Akero Clinical Study Site

Santiago, Santiago Metropolitan, 8330109, Chile

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Akero Clinical Study Site

Santiago, Santiago Metropolitan, 8380000, Chile

ACTIVE NOT RECRUITING

Akero Clinical Study Site

Strasbourg, Bas-Rhin, 67200, France

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Akero Clinical Study Site

Limoges, Haute-Vienne, 87042, France

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Akero Clinical Study Site

Lille, Hauts-de-France, 59037, France

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Akero Clinical Study Site

Clichy, Hauts-de-Seine, 92118, France

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Akero Clinical Study Site

Vandœuvre-lès-Nancy, Lorraine, 54511, France

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Akero Clinical Study Site

Angers, Maine-et-Loire, 49933, France

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Akero Clinical Study Site

Toulouse, Occitanie, 31059, France

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Akero Clinical Study Site

Marseille, Provence-Alpes-Côte d'Azur Region, 13008, France

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Akero Clinical Study Site

Montpellier Cedex 5, Provence-Alpes-Côte d'Azur Region, 34295, France

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Akero Clinical Study Site

Nice, Provence-Alpes-Côte d'Azur Region, 06202, France

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Akero Clinical Study Site

Lyon, Rhône, 69004, France

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Akero Clinical Study Site

Créteil, Val-de-Marne, 94010, France

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Akero Clinical Study Site

Le Chesnay, Île-de-France Region, 78150, France

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Akero Clinical Study Site

Paris, Île-de-France Region, 75013, France

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Akero Clinical Study Site

Frankfurt am Main, Hesse, 60590, Germany

ACTIVE NOT RECRUITING

Akero Clinical Study Site

Homburg, Saarland, 66421, Germany

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Akero Clinical Study Site

Leipzig, Saxony, 04103, Germany

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Akero Clinical Study Site

Leipzig, Saxony, 04103, Germany

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Akero Clinical Study Site

Lübeck, Schleswig-Holstein, 23538, Germany

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Akero Clinical Study Site

Berlin, State of Berlin, 13353, Germany

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Akero Clinical Study Site

Hyderabad, Andhra Pradesh, 500 082, India

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Akero Clinical Study Site

Surat, Gujarat, 395002, India

ACTIVE NOT RECRUITING

Akero Clinical Study Site

Surat, Gujarat, 395009, India

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Akero Clinical Study Site

Vadodara, Gujarat, 390007, India

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Akero Clinical Study Site

Mysore, Karnataka, 570001, India

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Akero Clinical Study Site

Thiruvananthapuram, Kerala, 695011, India

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Akero Clinical Study Site

Mumbai, Maharashtra, 400008, India

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Akero Clinical Study Site

Mumbai, Maharashtra, 400012, India

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Akero Clinical Study Site

Nagpur, Maharashtra, 440010, India

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Akero Clinical Study Site

Pune, Maharashtra, 412201, India

ACTIVE NOT RECRUITING

Akero Clinical Study Site

New Delhi, National Capital Territory of Delhi, 110 070, India

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Akero Clinical Study Site

New Delhi, National Capital Territory of Delhi, 110029, India

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Akero Clinical Study Site

New Delhi, National Capital Territory of Delhi, 110060, India

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Akero Clinical Study Site

Chandigarh, Punjab, 160012, India

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Akero Clinical Study Site

Ludhiana, Punjab, 141002, India

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Akero Clinical Study Site

Jaipur, Rajasthan, 302001, India

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Akero Clinical Study Site

Jaipur, Rajasthan, 302001, India

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Akero Clinical Study Site

Coimbatore, Tamil Nadu, 641005, India

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Akero Clinical Study Site

Hyderabad, Telangana, 500 004, India

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Akero Clinical Study Site

Varanasi, Uttar Pradesh, 221005, India

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Akero Clinical Study Site

Varanasi, Uttar Pradesh, 221005, India

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Akero Clinical Study Site

Rishikesh, Uttarakhand, 249203, India

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Akero Clinical Study Site

Kolkata, West Bengal, 700020, India

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Akero Clinical Study Site

Kolkata, West Bengal, 700020, India

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Akero Clinical Study Site

Kolkata, West Bengal, 700073, India

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Akero Clinical Study Site

Petah Tikva, Central District, 4941492, Israel

ACTIVE NOT RECRUITING

Akero Clinical Study Site

Ramat Gan, Central District, 5265601, Israel

RECRUITING

Akero Clinical Study Site

Haifa, Haifa District, 3109601, Israel

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Akero Clinical Study Site

Haifa, Haifa District, 3436212, Israel

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Akero Clinical Study Site

Jerusalem, Jerusalem, 9103102, Israel

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Akero Clinical Study Site

Jerusalem, Jerusalem, 9112001, Israel

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Akero Clinical Study Site

Afula, Northern District, 18101, Israel

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Akero Clinical Study Site

Nahariya, Northern District, 22100, Israel

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Akero Clinical Study Site

Tel Aviv, Tel Aviv, 6423906, Israel

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Akero Clinical Study Site

Tel Aviv, Tel Aviv, 69710, Israel

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Akero Clinical Study Site

Foggia, Apulia, 71122, Italy

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Akero Clinical Study Site

San Giovanni Rotondo, Foggia, 71013, Italy

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Akero Clinical Study Site

Messina, Messina, 98124, Italy

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Akero Clinical Study Site

Milan, Milan, 20122, Italy

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Akero Clinical Study Site

Milan, Milan, 20122, Italy

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Akero Clinical Study Site

Rozzano, Milan, 20089, Italy

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Akero Clinical Study Site

Novara, Novara, 28100, Italy

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Akero Clinical Study Site

Torino, Turin, 10126, Italy

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Akero Clinical Study Site

Bologna, 40138, Italy

RECRUITING

Akero Clinical Study Site

Catania, 95100, Italy

RECRUITING

Akero Clinical Study Site

Modena, 41124, Italy

RECRUITING

Akero Clinical Study Site

Acapulco de Juárez, Guerrero, 39670, Mexico

RECRUITING

Akero Clinical Study Site

Guadalajara, Jalisco, 44130, Mexico

RECRUITING

Akero Clinical Study Site

Cuauhtémoc, Mexico City, 06700, Mexico

RECRUITING

Akero Clinical Study Site

Mexico City, Mexico City, 01376, Mexico

RECRUITING

Akero Clinical Study Site

Mérida, Yucatán, 97070, Mexico

RECRUITING

Akero Clinical Study Site

Benito Juárez, 3330, Mexico

RECRUITING

Akero Clinical Study Site

Mexico City, 14050, Mexico

RECRUITING

Akero Clinical Study Site

Poznan, Greater Poland Voivodeship, 61-293, Poland

RECRUITING

Akero Clinical Study Site

Krakow, Lesser Poland Voivodeship, 31-501, Poland

RECRUITING

Akero Clinical Study Site

Wroclaw, Lower Silesian Voivodeship, 50-381, Poland

RECRUITING

Akero Clinical Study Site

Wroclaw, Lower Silesian Voivodeship, 53-673, Poland

RECRUITING

Akero Clinical Study Site

Lodz, Lódzkie, 91-473, Poland

RECRUITING

Akero Clinical Study Site

Warsaw, Masovian Voivodeship, 00-215, Poland

RECRUITING

Akero Clinical Study Site

Warsaw, Masovian Voivodeship, 02-672, Poland

RECRUITING

Akero Clinical Study Site

Gdansk, Pomeranian Voivodeship, Poland 80-382, Poland

RECRUITING

Akero Clinical Study Site

Częstochowa, Silesian Voivodeship, 42-202, Poland

RECRUITING

Akero Clinical Study Site

Katowice, Silesian Voivodeship, 40-752, Poland

RECRUITING

Akero Clinical Study Site

Manati, Manatí, 00674, Puerto Rico

RECRUITING

Akero Clinical Study Site

Mayagüez, Puerto Rico, 00680, Puerto Rico

RECRUITING

Akero Clinical Study Site

San Juan, Puerto Rico, 00927, Puerto Rico

RECRUITING

Akero Clinical Study Site

Daegu, Daegu Gwang'Yeogsi [Taegu-Kwangyokshi], 41944, South Korea

RECRUITING

Akero Clinical Study Site

Incheon, Gyeonggi-do, 22332, South Korea

RECRUITING

Akero Clinical Study Site

Goyang-si, Gyeonggido, 10444, South Korea

RECRUITING

Akero Clinical Study Site

Daegu, Gyeongsangbugdo [Kyongsangbuk-do], 42601, South Korea

RECRUITING

Akero Clinical Study Site

Seoul, Seoul Teugbyeolsi [Seoul-T'Ukpyolshi], 03080, South Korea

RECRUITING

Akero Clinical Study Site

Seoul, Seoul Teugbyeolsi, 04763, South Korea

RECRUITING

Akero Clinical Study Site

Barcelona, Barcelona, 08035, Spain

RECRUITING

Akero Clinical Study Site

Sabadell, Barcelona, 08208, Spain

RECRUITING

Akero Clinical Study Site

Santander, Cantabria, 39008, Spain

RECRUITING

Akero Clinical Study Site

Madrid, Madrid, 28007, Spain

RECRUITING

Akero Clinical Study Site

Madrid, Madrid, 28027, Spain

RECRUITING

Akero Clinical Study Site

Majadahonda, Madrid, 28222, Spain

ACTIVE NOT RECRUITING

Akero Clinical Study Site

Seville, Sevilla, 41013, Spain

RECRUITING

Akero Clinical Study Site

Valencia, Valencia, 46010, Spain

RECRUITING

Akero Clinical Study Site

Valencia, Valencia, 46015, Spain

RECRUITING

Akero Clinical Study Site

Bern, Canton of Bern, 3010, Switzerland

RECRUITING

Akero Clinical Study Site

Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

RECRUITING

Akero Clinical Study Site

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

Akero Clinical Study Site

Lugano, Canton Ticino, 6900, Switzerland

RECRUITING

Akero Clinical Study Site

Ankara, Ankara, 06560, Turkey (Türkiye)

ACTIVE NOT RECRUITING

Akero Clinical Study Site

Bursa, Bursa, 16059, Turkey (Türkiye)

RECRUITING

Akero Clinical Study Site

Rize, Rize Province, 53020, Turkey (Türkiye)

RECRUITING

Akero Clinical Study Site

London, England, SE5 9RS, United Kingdom

RECRUITING

Akero Clinical Study Site

Nottingham, England, NG7 2UH, United Kingdom

RECRUITING

Akero Clinical Study Site

Birmingham, B15 2TH, United Kingdom

RECRUITING

Akero Clinical Study Site

London, NW3 2QG, United Kingdom

RECRUITING

Akero Clinical Study Site

London, SW10 9NH, United Kingdom

RECRUITING

Akero Clinical Study Site

Newcastle upon Tyne, NE7 7DN, United Kingdom

RECRUITING

Akero Clinical Study Site

Whitechapel, E1 1FR, United Kingdom

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Central Study Contacts

Akero Study Director

CONTACT

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2024

First Posted

July 30, 2024

Study Start

September 4, 2024

Primary Completion (Estimated)

February 1, 2030

Study Completion (Estimated)

March 1, 2030

Last Updated

April 24, 2026

Record last verified: 2026-04

Locations