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

Obesity/Overweight Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05295875
• Other study ID #: ALT-801-211
• Status: Completed
• Phase: Phase 2
• Start date: March 31, 2022
• Est. completion date: September 28, 2023

Study information

• Verified date: November 2023
• Source: Altimmune, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 391
• Est. completion date: September 28, 2023
• Est. primary completion date: September 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Obesity
• Obesity/Overweight
• Overweight

Intervention

Drug:
• ALT-801
Injected subcutaneously (SC)

Other:
• Placebo
Injected subcutaneously (SC)

Locations

Country	Name	City	State
United States	Altimmune CTM	Austin	Texas
United States	Altimmune CTM	Baton Rouge	Louisiana
United States	Altimmune CTM	Bellaire	Texas
United States	Altimmune CTM	Berlin	New Jersey
United States	Altimmune CTM	Birmingham	Alabama
United States	Altimmune CTM	Boca Raton	Florida
United States	Altimmune CTM	Butte	Montana
United States	Altimmune CTM	Cincinnati	Ohio
United States	Altimmune CTM	Clearwater	Florida
United States	Altimmune CTM	Evanston	Illinois
United States	Altimmune CTM	Fort Myers	Florida
United States	Altimmune CTM	Indianapolis	Indiana
United States	Midwest Institute for Clinical Research	Indianapolis	Indiana
United States	Altimmune CTM	Jacksonville	Florida
United States	Altimmune CTM	Kansas City	Missouri
United States	Altimmune CTM	Knoxville	Tennessee
United States	Altimmune CTM	Los Angeles	California
United States	National Research Institute	Los Angeles	California
United States	Altimmune CTM	Louisville	Kentucky
United States	Altimmune CTM	Mesa	Arizona
United States	Altimmune CTM	Montclair	California
United States	Altimmune CTM	New Orleans	Louisiana
United States	Altimmune CTM	New York	New York
United States	Cornell University, Joan and Sanford Weill Medical College	New York	New York
United States	Altimmune CTM	Philadelphia	Pennsylvania
United States	Altimmune CTM	Port Orange	Florida
United States	Altimmune CTM	Saint George	Utah
United States	Altimmune CTM	San Antonio	Texas
United States	Altimmune CTM	Santa Barbara	California
United States	Altimmune CTM	Savannah	Georgia
United States	Altimmune CTM	Sunrise	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Altimmune, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative change from baseline in body weight percentage		Baseline to Week 48
Secondary	Percent proportion of subjects with weight loss of greater than or equal to 5%, 10%, and 15%		Baseline to Week 48
Secondary	Change from baseline in lipids		Baseline to Week 48
Secondary	The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs)		Baseline to Week 48
Secondary	Changes from baseline in Fasting Glucose		Baseline to Week 48
Secondary	Changes from baseline in Hemoglobin A1c		Baseline to Week 48
Secondary	Changes from baseline in Homeostatic Marker Assessment for Insulin Resistance (HOMA-IR)		Baseline to Week 48
Secondary	Changes from baseline in: a) Systolic blood pressure, b) Diastolic blood pressure		Baseline to Week 48
Secondary	Change from baseline in proportion of patients using antihypertensive medications		Baseline to Week 48