A Study of Once-daily Oral ASC30 to Evaluate the Efficacy and Safety in Adult Participants With Obesity or Overweight With Type 2 Diabetes

NCT07743450 | Recruiting Phase 3 FDA Drug

• 1 other identifier: ASC30-302
• Study Type: interventional
• Target: 1,560
• Locations: 6 countries
• Sites: 135

Brief Summary

Study ASC30-302 (AURORA-2) is a Phase III, global, multicenter, randomized, double-blind, placebo-controlled study to investigate the long-term efficacy, safety, and tolerability of three maintenance doses of once-daily oral ASC30 compared with placebo in participants with obesity or overweight and T2DM.

Conditions

Chronic Weight Management; Obesity; Overweight; Type 2 Diabetes Mellitus

Keywords

Obesity; Overweight; Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Percent change from baseline in body weight

  Baseline to Week 72

Secondary Outcomes (10)

• Change from baseline in HbA1c (%)

  Baseline to Week 72

• Change from baseline in fasting serum glucose (mg/dL)

  Baseline to Week 72

• Change from baseline in systolic blood pressure (SBP) (mmHg)

  Baseline to Week 72

• Percent change from baseline in fasting non-HDL cholesterol

  Baseline to Week 72

• Percent change from baseline in fasting triglycerides

  Baseline to Week 72

Study Arms (4)

ASC30 Cohort 1

EXPERIMENTAL

Participants will receive oral ASC30 tablets A1.

Drug: ASC30 tablets A1

ASC30 Cohort 2

EXPERIMENTAL

Participants will receive oral ASC30 tablets A1.

Drug: ASC30 tablets A1

ASC30 Cohort 3

EXPERIMENTAL

Participants will receive oral ASC30 tabletsA1.

Drug: ASC30 tablets A1

Placebo Cohort 4

PLACEBO COMPARATOR

Participants will receive matching placebo tablets orally once daily.

Drug: Placebo

Interventions

ASC30 tablets A1 DRUG

ASC30 tablets A1 administered orally once daily.

ASC30 Cohort 1; ASC30 Cohort 2; ASC30 Cohort 3

Placebo DRUG

Matching placebo tablets administered orally once daily.

Placebo Cohort 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must be ≥18 years of age inclusive, or the legal age of consent in the jurisdiction in which the study is taking place at screening.
• Have a BMI ≥ 27 kg/m2 at screening.
• Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.
• Have a diagnosis of T2D according to the WHO classification or other locally applicable standards, with HbA1c \> 6.5% (48 mmol/mol) to ≤10.5% (91 mmol/mol) at screening.

You may not qualify if:

• Have Type 1 Diabetes Mellitus (T1DM), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2DM.
• Have a self-reported change in body weight \>5 kg (11 pounds) within 3 months prior to screening.
• Have an estimated glomerular filtration rate (eGFR) \< 15 mL/min/1.73 m2, as determined by the laboratory at screening.
• Have a history of acute or chronic pancreatitis any time prior to screening.
• Have known allergies or intolerance to glucagon-like peptide-1 Receptor Agonists (GLP-1 RA).
• Participants with a personal or family (first-degree relative) history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia (MEN) syndrome type 2.
• Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study at the investigator's discretion.

Sponsors & Collaborators

• Ascletis Pharma (China) Co., Limited: lead

Study Sites (135)

AURORA-2 Clinical Site

Birmingham, Alabama, 35211-1320, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Huntsville, Alabama, 35802, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Peoria, Arizona, 85382, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Phoenix, Arizona, 85020, United States

RECRUITING

AURORA-2 Clinical Site

Tucson, Arizona, 85741, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Little Rock, Arkansas, 72204, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Banning, California, 92220-3082, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Chula Vista, California, 91910, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Covina, California, 91723-1905, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Gardena, California, 90247-3583, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

La Mesa, California, 91942, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Los Angeles, California, 91405, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Sacramento, California, 95821-2640, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Tarzana, California, 91356-3508, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Tustin, California, 92780-7074, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Washington D.C., District of Columbia, 20016, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Boca Raton, Florida, 33434, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Daytona Beach, Florida, 32114, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Jacksonville, Florida, 32205-4785, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Leesburg, Florida, 34748-5077, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Melbourne, Florida, 32934-8172, United States

RECRUITING

AURORA-2 Clinical Site

South Miami, Florida, 33143, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Tampa, Florida, 33613-1244, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

The Villages, Florida, 32162, United States

RECRUITING

AURORA-2 Clinical Site

Winter Park, Florida, 32789-4681, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Canton, Georgia, 30115, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Decatur, Georgia, 30030-3440, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Union City, Georgia, 30291-2085, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Boise, Idaho, 83704, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Schaumburg, Illinois, 60173, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Evansville, Indiana, 47714-7513, United States

RECRUITING

AURORA-2 Clinical Site

Indianapolis, Indiana, 46254, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Valparaiso, Indiana, 46383, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Kansas City, Kansas, 66112, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Baton Rouge, Louisiana, 70809-3416, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Metairie, Louisiana, 70006, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Bowie, Maryland, 20715, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Rockville, Maryland, 20854-2931, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Southfield, Michigan, 48076-5412, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Mankato, Minnesota, 56001, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Gulfport, Mississippi, 39503-2637, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Jackson, Mississippi, 39206, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Olive Branch, Mississippi, 38654-3514, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Columbia, Missouri, 65201, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

St Louis, Missouri, 63141, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Las Vegas, Nevada, 89113, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Jersey City, New Jersey, 07306-4004, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

East Northport, New York, 11731, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

East Syracuse, New York, 13057, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

New Windsor, New York, 12553-7754, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Charlotte, North Carolina, 28262, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Durham, North Carolina, 27701, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Greenville, North Carolina, 27834-5051, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Morehead City, North Carolina, 28557, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Raleigh, North Carolina, 27610, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Cincinnati, Ohio, 45246, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Cleveland, Ohio, 44122-4330, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Columbus, Ohio, 43212-3122, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Dayton, Ohio, 45414, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Oklahoma City, Oklahoma, 73118-2872, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Eugene, Oregon, 97404-3233, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Philadelphia, Pennsylvania, 19107, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Pittsburgh, Pennsylvania, 15243-1800, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Bluffton, South Carolina, 29910, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Clemson, South Carolina, 29634, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Columbia, South Carolina, 29204, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Gaffney, South Carolina, 29340-4737, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Memphis, Tennessee, 38119-4823, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Austin, Texas, 78744-1645, United States

RECRUITING

AURORA-2 Clinical Site

Brownsville, Texas, 78520, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

DeSoto, Texas, 75115-2043, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Frisco, Texas, 75033-4133, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Houston, Texas, 77024, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Mesquite, Texas, 75149, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

San Antonio, Texas, 78229-3272, United States

RECRUITING

AURORA-2 Clinical Site

San Antonio, Texas, 78229-3539, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Sugar Land, Texas, 77478, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Tomball, Texas, 77375, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Waxahachie, Texas, 75165-1430, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Weslaco, Texas, 78596-7288, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Wichita Falls, Texas, 76301, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Salt Lake City, Utah, 84124-3543, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Hampton, Virginia, 23666, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Seattle, Washington, 98122, United States

NOT YET RECRUITING

AURORA-2 Clinical Site

Pardubice, 530 02, Czechia

NOT YET RECRUITING

AURORA-2 Clinical Site

Prague, 120 00, Czechia

NOT YET RECRUITING

AURORA-2 Clinical Site

Prague, 150 00, Czechia

NOT YET RECRUITING

AURORA-2 Clinical Site

Uherské Hradiště, 686 01, Czechia

NOT YET RECRUITING

AURORA-2 Clinical Site

Berlin, 10629, Germany

NOT YET RECRUITING

AURORA-2 Clinical Site

Berlin, 10787, Germany

NOT YET RECRUITING

AURORA-2 Clinical Site

Essen, 45355, Germany

NOT YET RECRUITING

AURORA-2 Clinical Site

Hanover, 30159, Germany

NOT YET RECRUITING

AURORA-2 Clinical Site

Athens, 106 76, Greece

NOT YET RECRUITING

AURORA-2 Clinical Site

Athens, 115 27, Greece

NOT YET RECRUITING

AURORA-2 Clinical Site

Athens, 115 28, Greece

NOT YET RECRUITING

AURORA-2 Clinical Site

Larissa, 411 10, Greece

NOT YET RECRUITING

AURORA-2 Clinical Site

Marousi, 151 23, Greece

NOT YET RECRUITING

AURORA-2 Clinical Site

Palaió Fáliro, 175 62, Greece

NOT YET RECRUITING

AURORA-2 Clinical Site

Pylaia, 570 01, Greece

NOT YET RECRUITING

AURORA-2 Clinical Site

Thessaloniki, 546 36, Greece

NOT YET RECRUITING

AURORA-2 Clinical Site

Thessaloniki, 546 42, Greece

NOT YET RECRUITING

AURORA-2 Clinical Site

Biała Podlaska, 21-500, Poland

NOT YET RECRUITING

AURORA-2 Clinical Site

Bydgoszcz, 85-092, Poland

NOT YET RECRUITING

AURORA-2 Clinical Site

Częstochowa, 42-202, Poland

NOT YET RECRUITING

AURORA-2 Clinical Site

Gdansk, 80-382, Poland

NOT YET RECRUITING

AURORA-2 Clinical Site

Gdynia, 81-384, Poland

NOT YET RECRUITING

AURORA-2 Clinical Site

Gdynia, 81-537, Poland

NOT YET RECRUITING

AURORA-2 Clinical Site

Katowice, 40-040, Poland

NOT YET RECRUITING

AURORA-2 Clinical Site

Krakow, 31-261, Poland

NOT YET RECRUITING

AURORA-2 Clinical Site

Krakow, 31-501, Poland

NOT YET RECRUITING

AURORA-2 Clinical Site

Lodz, 90-127, Poland

NOT YET RECRUITING

AURORA-2 Clinical Site

Lodz, 91-363, Poland

NOT YET RECRUITING

AURORA-2 Clinical Site

Lublin, 20-011, Poland

NOT YET RECRUITING

AURORA-2 Clinical Site

Lublin, 20-362, Poland

NOT YET RECRUITING

AURORA-2 Clinical Site

Poznan, 60-324, Poland

NOT YET RECRUITING

AURORA-2 Clinical Site

Poznan, 60-702, Poland

NOT YET RECRUITING

AURORA-2 Clinical Site

Puławy, 24-100, Poland

NOT YET RECRUITING

AURORA-2 Clinical Site

Siedlce, 08-110, Poland

NOT YET RECRUITING

AURORA-2 Clinical Site

Staszów, 28-200, Poland

NOT YET RECRUITING

AURORA-2 Clinical Site

Torun, 87-100, Poland

NOT YET RECRUITING

AURORA-2 Clinical Site

Warsaw, 00-215, Poland

NOT YET RECRUITING

AURORA-2 Clinical Site

Warsaw, 00-710, Poland

NOT YET RECRUITING

AURORA-2 Clinical Site

Warsaw, 01-696, Poland

NOT YET RECRUITING

AURORA-2 Clinical Site

Warsaw, 02-672, Poland

NOT YET RECRUITING

AURORA-2 Clinical Site

Warsaw, 03-291, Poland

NOT YET RECRUITING

AURORA-2 Clinical Site

Wroclaw, 50-381, Poland

NOT YET RECRUITING

AURORA-2 Clinical Site

Wroclaw, 53-673, Poland

NOT YET RECRUITING

AURORA-2 Clinical Site

Cardiff, CF15 9SS, United Kingdom

NOT YET RECRUITING

AURORA-2 Clinical Site

Edgbaston, B16 8QQ, United Kingdom

NOT YET RECRUITING

AURORA-2 Clinical Site

Glasgow, ML43NJ, United Kingdom

NOT YET RECRUITING

AURORA-2 Clinical Site

London, E1 1AG, United Kingdom

NOT YET RECRUITING

AURORA-2 Clinical Site

Manchester, M11 1AA, United Kingdom

NOT YET RECRUITING

AURORA-2 Clinical Site

Manchester, M156SE, United Kingdom

NOT YET RECRUITING

AURORA-2 Clinical Site

Stoke-on-Trent, ST1 5SJ, United Kingdom

NOT YET RECRUITING

AURORA-2 Clinical Site

Warrington, WA1 3TZ, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Obesity; Overweight; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Design

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

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 3, 2026
• Study Start: August 28, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: September 16, 2026

Record last verified: 2026-09

Locations

PL (26); DE (4); GR (9); GB (8); CZ (4); US (84)