Efficacy and Safety of ALT-801 in the Treatment of Obesity

NCT05295875 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: ALT-801-211
• Study Type: interventional
• Target: 391
• Locations: 1 country
• Sites: 31

Brief Summary

This study will evaluate the efficacy and safety of ALT-801 once-weekly versus placebo as an adjunct to a reduced-calorie diet and increased physical activity in patients with obesity/overweight.

Conditions

Obesity/Overweight

Outcome Measures

Primary Outcomes (1)

• Relative change from baseline in body weight percentage

  Baseline to Week 48

Secondary Outcomes (8)

• Percent proportion of subjects with weight loss of greater than or equal to 5%, 10%, and 15%

  Baseline to Week 48

• Change from baseline in lipids

  Baseline to Week 48

• The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs)

  Baseline to Week 48

• Changes from baseline in Fasting Glucose

  Baseline to Week 48

• Changes from baseline in Hemoglobin A1c

  Baseline to Week 48

Study Arms (4)

ALT-801 Dose Level 1

EXPERIMENTAL

Drug: ALT-801

ALT-801 Dose Level 2

EXPERIMENTAL

Drug: ALT-801

ALT-801 Dose Level 3

EXPERIMENTAL

Drug: ALT-801

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

ALT-801 DRUG

Injected subcutaneously (SC)

ALT-801 Dose Level 1; ALT-801 Dose Level 2; ALT-801 Dose Level 3

Placebo OTHER

Injected subcutaneously (SC)

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent signed prior to entry into the study
• Male or female age 18 to 75 years, inclusive
• Body mass index (BMI) ≥ 30 kg/m2 or BMI ≥ 27 kg/m2 combined with at least one obesity-related comorbidity
• At least one unsuccessful weight loss attempt per investigator judgement
• Agreement to comply with the study-required life-style intervention and treatment during the full duration of the study
• Female subjects of childbearing potential who are not pregnant or breastfeeding, do not plan to become pregnant during the study, and agree to use effective birth control

You may not qualify if:

• Weight gain or loss \> 5% in the 3 months prior to randomization or \>10% in the 6 months prior to screening
• Diabetes and related conditions:
• History or clinical evidence of diabetes mellitus of any type, including Type 1, Type 2, or mature onset diabetes of the young (MODY)
• HbA1c \> 6.5%, fasting glucose ≥ 126 mg/dL (6.9 mmol/L), and/or random glucose of ≥ 200 mg/dL (11.0mmol/L) at screening
• Obesity and related conditions:
• Obesity induced by known genetic causes or endocrine disorders (eg, Cushing Syndrome, inadequately treated hypothyroidism, defined as thyroid-stimulating hormone \[TSH\] \> 6 mIU/L)
• History of bariatric surgery or other surgical treatment for obesity (eg, gastric banding, gastric bypass), or planned surgery or surgical treatment during the study. Liposuction and/or abdominoplasty performed \>1 year before screening is allowed. Endoscopically placed intragastric balloons will be allowed if removed \> 1 year before screening.
• Gastrointestinal conditions:
• History of acute or chronic pancreatitis within 1 year (365 days) before screening
• History of or acute significant gastrointestinal (GI) disorder (eg, peptic ulcers, severe gastroesophageal reflux disease \[GERD\],
• History of GI surgery, including cholecystectomy and antrectomy. Surgery for appendicitis and small bowel resection \>20cm is acceptable.
• History of inflammatory bowel disease, celiac disease or any medical condition or surgery that could affect gastric emptying, stool frequency or stool consistency. (Irritable bowel syndrome is permitted provided that bowel frequency and consistency are normal off treatment.)
• Mental health conditions:
• Untreated depressive disorder, defined as a Patient Health Questionaire-9 (PHQ-9) score of ≥ 15 at screening
• Suicide ideation, defined as type 4 or 5 on the Columbia-Suicide Severity Rating Scale(C-SSRS) at screening, lifelong history of a suicide attempt, or suicidal behavior within 30 days before screening

Sponsors & Collaborators

• Altimmune, Inc.: lead

Study Sites (31)

Altimmune CTM

Birmingham, Alabama, 35020, United States

Location

Altimmune CTM

Mesa, Arizona, 85201, United States

Location

Altimmune CTM

Los Angeles, California, 90001, United States

Location

National Research Institute

Los Angeles, California, 90057, United States

Location

Altimmune CTM

Montclair, California, 91763, United States

Location

Altimmune CTM

Santa Barbara, California, 93101, United States

Location

Altimmune CTM

Boca Raton, Florida, 33427, United States

Location

Altimmune CTM

Clearwater, Florida, 33755, United States

Location

Altimmune CTM

Fort Myers, Florida, 33900, United States

Location

Altimmune CTM

Jacksonville, Florida, 32201, United States

Location

Altimmune CTM

Port Orange, Florida, 32123, United States

Location

Altimmune CTM

Sunrise, Florida, 33319, United States

Location

Altimmune CTM

Savannah, Georgia, 31411, United States

Location

Altimmune CTM

Evanston, Illinois, 60201, United States

Location

Altimmune CTM

Indianapolis, Indiana, 46201, United States

Location

Midwest Institute for Clinical Research

Indianapolis, Indiana, 46260, United States

Location

Altimmune CTM

Louisville, Kentucky, 40202, United States

Location

Altimmune CTM

Baton Rouge, Louisiana, 70801, United States

Location

Altimmune CTM

New Orleans, Louisiana, 70119, United States

Location

Altimmune CTM

Kansas City, Missouri, 64101, United States

Location

Altimmune CTM

Butte, Montana, 59701, United States

Location

Altimmune CTM

Berlin, New Jersey, 08009, United States

Location

Altimmune CTM

New York, New York, 10001, United States

Location

Cornell University, Joan and Sanford Weill Medical College

New York, New York, 10065, United States

Location

Altimmune CTM

Cincinnati, Ohio, 45201, United States

Location

Altimmune CTM

Philadelphia, Pennsylvania, 19092, United States

Location

Altimmune CTM

Knoxville, Tennessee, 37901, United States

Location

Altimmune CTM

Austin, Texas, 78701, United States

Location

Altimmune CTM

Bellaire, Texas, 77401, United States

Location

Altimmune CTM

San Antonio, Texas, 78201, United States

Location

Altimmune CTM

St. George, Utah, 84770, United States

Location

MeSH Terms

Conditions

Obesity; Overweight

Interventions

ALT-801

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sarah K Browne, MD

  Altimmune, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2022
• First Posted: March 25, 2022
• Study Start: March 31, 2022
• Primary Completion: September 28, 2023
• Study Completion: September 28, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

US (31)