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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
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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
Exclusion criteria
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
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.
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.)
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
Weight & body composition
2 endpointsRelative change from baseline in body weight percentage
Time frame:Baseline to Week 48
Body weight, % change
percent change from baseline, improvement
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 endpointsChanges from baseline in Fasting Glucose
Time frame:Baseline to Week 48
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Changes from baseline in Hemoglobin A1c
Time frame:Baseline to Week 48
HbA1c, change
change from baseline, improvement
LOINC 4548-4
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 endpointsChange from baseline in lipids
Time frame:Baseline to Week 48
change from baseline, improvement
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
Change from baseline in proportion of patients using antihypertensive medications
Time frame:Baseline to Week 48
change from baseline, improvement
Safety / tolerability / PK
1 endpointThe 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 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.