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CompletedPhase 2

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)

Lead sponsor

Altimmune, Inc.

Asset

Pemvidutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

31

Recruiting sites

Enrollment

391

actual

Study population

Obesity / overweight

Key I/E criterion

BMI ≥30

Primary endpoint

Body weight, % change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05295875
Org study IDALT-801-211

Timeline

Milestones

Study first posted2022-03-25actual
Study start2022-03-31actual
Primary completion2023-09-28actual
Study completion2023-09-28actual
Last update posted2023-11-29actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

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)

Endpoints (9)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes
3
Cardiometabolic biomarkers
3
Weight & body composition
2
Safety / tolerability / PK
1

Weight & body composition

2 endpoints
Primary/protocol endpoint

Relative change from baseline in body weight percentage

Time frame:Baseline to Week 48

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint/low confidence

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

Time frame:Baseline to Week 48

threshold achievement, improvement

Glycemic / diabetes

3 endpoints
Secondary/protocol endpoint

Changes from baseline in Fasting Glucose

Time frame:Baseline to Week 48

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Changes from baseline in Hemoglobin A1c

Time frame:Baseline to Week 48

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Changes from baseline in Homeostatic Marker Assessment for Insulin Resistance (HOMA-IR)

Time frame:Baseline to Week 48

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Cardiometabolic biomarkers

3 endpoints
Secondary/protocol endpoint

Change from baseline in lipids

Time frame:Baseline to Week 48

change from baseline, improvement

Secondary/protocol endpoint

Changes from baseline in: a) Systolic blood pressure, b) Diastolic blood pressure

Time frame:Baseline to Week 48

change from baseline, improvement

componentsSystolic BP, change, Diastolic BP, change

Secondary/protocol endpoint/low confidence

Change from baseline in proportion of patients using antihypertensive medications

Time frame:Baseline to Week 48

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

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

Time frame:Baseline to Week 48

Treatment-emergent AEs (any)

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.