> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/efficacy-and-safety-of-alt-801-in-the-treatment-of-obesity-46700d91-2e78-4178-90a1-7dddd242a39d > Record changed: 2026-10-13 # Efficacy and Safety of ALT-801 in the Treatment of Obesity NCT05295875 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05295875) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05295875) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05295875) Participants 391 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05295875) Lead sponsor Altimmune, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05295875) Start date 2022-03-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05295875) Number of sites 31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05295875) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05295875) **Short title** Efficacy and Safety of ALT-801 in the Treatment of Obesity Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05295875) **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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05295875) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05295875) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05295875) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05295875) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05295875) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05295875) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05295875) ## Dates **Completion date** 2023-09-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05295875) **First posted** 2022-03-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05295875) **Registry last updated** 2023-11-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05295875) **Primary completion date** 2023-09-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05295875) **Start date** 2022-03-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05295875) ## Size and sites **Actual participants** 391 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05295875) **Participants** 391 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05295875) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05295875) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05295875) **Number of sites** 31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05295875) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05295875) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05295875) **Lead sponsor** Altimmune, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05295875) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05295875) ## Identifiers **Registry ID** NCT05295875 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05295875) **ClinicalTrials.gov ID** NCT05295875 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05295875) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05295875) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05295875) ## Outcomes ### Primary outcomes 1. Relative change from baseline in body weight percentage Timeframe: Baseline to Week 48 ### Secondary outcomes 1. Percent proportion of subjects with weight loss of greater than or equal to 5%, 10%, and 15% Timeframe: Baseline to Week 48 2. Change from baseline in lipids Timeframe: Baseline to Week 48 3. The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs) Timeframe: Baseline to Week 48 4. Changes from baseline in Fasting Glucose Timeframe: Baseline to Week 48 5. Changes from baseline in Hemoglobin A1c Timeframe: Baseline to Week 48 6. Changes from baseline in Homeostatic Marker Assessment for Insulin Resistance (HOMA-IR) Timeframe: Baseline to Week 48 7. Changes from baseline in: a) Systolic blood pressure, b) Diastolic blood pressure Timeframe: Baseline to Week 48 8. Change from baseline in proportion of patients using antihypertensive medications Timeframe: Baseline to Week 48 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05295875) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### 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) Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05295875) ## Sites - Altimmune CTMBirmingham, United States - Altimmune CTMMesa, United States - Altimmune CTMLos Angeles, United States - National Research InstituteLos Angeles, United States - Altimmune CTMMontclair, United States - Altimmune CTMSanta Barbara, United States - Altimmune CTMBoca Raton, United States - Altimmune CTMClearwater, United States - Altimmune CTMFort Myers, United States - Altimmune CTMJacksonville, United States - Altimmune CTMPort Orange, United States - Altimmune CTMSunrise, United States - Altimmune CTMSavannah, United States - Altimmune CTMEvanston, United States - Altimmune CTMIndianapolis, United States - Midwest Institute for Clinical ResearchIndianapolis, United States - Altimmune CTMLouisville, United States - Altimmune CTMBaton Rouge, United States - Altimmune CTMNew Orleans, United States - Altimmune CTMKansas City, United States - Altimmune CTMButte, United States - Altimmune CTMBerlin, United States - Altimmune CTMNew York, United States - Cornell University, Joan and Sanford Weill Medical CollegeNew York, United States - Altimmune CTMCincinnati, United States And 6 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05295875) ## Related records ### Drugs (1) - [Pemvidutide](https://trialight.com/data/asset/pemvidutide-84c00953-821c-44fd-ba06-b55270f15881.md) ### Lead sponsors (1) - [Altimmune, Inc.](https://trialight.com/data/company/altimmune-inc-0fdc674f-7f1f-4d65-bb16-17839afb3154.md) ### Conditions (1) - [Obesity disorder](https://trialight.com/data/condition/obesity-disorder-f3b57dc0-68ac-555c-8f13-0d81e595d9cb.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. Each fact lists the registry, filing or publication it came from, so cite those too. - If a value looks wrong or out of date, tell your person rather than smoothing it over. 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