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

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled and Parallel Group 48-Week Study to Evaluate the Efficacy and Safety of ALT-801 in the Treatment of Obesity (MOMENTUM Trial)

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.

Study Overview

• Status: Completed
• Conditions: Obesity/Overweight
• Intervention / Treatment: Drug: ALT-801; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 391
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35020
      • Altimmune CTM
  • Arizona
    • Mesa, Arizona, United States, 85201
      • Altimmune CTM
  • California
    • Los Angeles, California, United States, 90057
      • National Research Institute
    • Los Angeles, California, United States, 90001
      • Altimmune CTM
    • Montclair, California, United States, 91763
      • Altimmune CTM
    • Santa Barbara, California, United States, 93101
      • Altimmune CTM
  • Florida
    • Boca Raton, Florida, United States, 33427
      • Altimmune CTM
    • Clearwater, Florida, United States, 33755
      • Altimmune CTM
    • Fort Myers, Florida, United States, 33900
      • Altimmune CTM
    • Jacksonville, Florida, United States, 32201
      • Altimmune CTM
    • Port Orange, Florida, United States, 32123
      • Altimmune CTM
    • Sunrise, Florida, United States, 33319
      • Altimmune CTM
  • Georgia
    • Savannah, Georgia, United States, 31411
      • Altimmune CTM
  • Illinois
    • Evanston, Illinois, United States, 60201
      • Altimmune CTM
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Midwest Institute for Clinical Research
    • Indianapolis, Indiana, United States, 46201
      • Altimmune CTM
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Altimmune CTM
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70801
      • Altimmune CTM
    • New Orleans, Louisiana, United States, 70119
      • Altimmune CTM
  • Missouri
    • Kansas City, Missouri, United States, 64101
      • Altimmune CTM
  • Montana
    • Butte, Montana, United States, 59701
      • Altimmune CTM
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • Altimmune CTM
  • New York
    • New York, New York, United States, 10001
      • Altimmune CTM
    • New York, New York, United States, 10065
      • Cornell University, Joan and Sanford Weill Medical College
  • Ohio
    • Cincinnati, Ohio, United States, 45201
      • Altimmune CTM
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19092
      • Altimmune CTM
  • Tennessee
    • Knoxville, Tennessee, United States, 37901
      • Altimmune CTM
  • Texas
    • Austin, Texas, United States, 78701
      • Altimmune CTM
    • Bellaire, Texas, United States, 77401
      • Altimmune CTM
    • San Antonio, Texas, United States, 78201
      • Altimmune CTM
  • Utah
    • Saint George, Utah, United States, 84770
      • Altimmune CTM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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:

  1. History or clinical evidence of diabetes mellitus of any type, including Type 1, Type 2, or mature onset diabetes of the young (MODY)
  2. 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:

  1. Obesity induced by known genetic causes or endocrine disorders (eg, Cushing Syndrome, inadequately treated hypothyroidism, defined as thyroid-stimulating hormone [TSH] > 6 mIU/L)
  2. 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:

  1. History of acute or chronic pancreatitis within 1 year (365 days) before screening
  2. History of or acute significant gastrointestinal (GI) disorder (eg, peptic ulcers, severe gastroesophageal reflux disease [GERD],
  3. History of GI surgery, including cholecystectomy and antrectomy. Surgery for appendicitis and small bowel resection >20cm is acceptable.
  4. 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:

  1. Untreated depressive disorder, defined as a Patient Health Questionaire-9 (PHQ-9) score of ≥ 15 at screening
  2. 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
  3. Other severe psychiatric disorder (eg, schizophrenia, bipolar disorder)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; Injected subcutaneously (SC)
Experimental: ALT-801 Dose Level 1	Drug: ALT-801; Injected subcutaneously (SC)
Experimental: ALT-801 Dose Level 2	Drug: ALT-801; Injected subcutaneously (SC)
Experimental: ALT-801 Dose Level 3	Drug: ALT-801; Injected subcutaneously (SC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Relative change from baseline in body weight percentage	Baseline to Week 48

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Changes from baseline in Homeostatic Marker Assessment for Insulin Resistance (HOMA-IR)	Baseline to Week 48
Changes from baseline in: a) Systolic blood pressure, b) Diastolic blood pressure	Baseline to Week 48
Change from baseline in proportion of patients using antihypertensive medications	Baseline to Week 48

Collaborators and Investigators

• Sponsor: Altimmune, Inc.
• Investigators: Study Director: Sarah K Browne, MD, Altimmune, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2022
• Primary Completion (Actual): September 28, 2023
• Study Completion (Actual): September 28, 2023

Study Registration Dates

• First Submitted: February 7, 2022
• First Submitted That Met QC Criteria: March 21, 2022
• First Posted (Actual): March 25, 2022

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Obesity; Overweight
• Other Study ID Numbers: ALT-801-211

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No