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Study to Assess the Effect and Safety of ALV-100 on Maintenance of Weight Loss
RecruitingPhase 2
A Double-Blind, Randomized, Multi-Center, Dose-Ranging, Phase 2 Study of the Efficacy and Safety of ALV-100 Versus Placebo for Maintenance of Weight Loss in Patients Previously Treated With Incretin-Based Therapies
Who can join
Ages 18 to 75 · All sexes
Full eligibility criteria
Key inclusion criteria 1. Adult male and female participants, aged ≥18 to ≤75 2. BMI ≥27 kg/m2 at screening. 3. Has been treated with incretin-based therapy for weight management at a stable dose for at least 3 continuous months prior to screening. 4. Tolerating incretin-based therapy at the discretion of the investigator 5. WL of at least 10% while on incretin-based therapy and with stable BW for at least 3 months prior to screening. 6. Willing to maintain their current general diet and physical activity regimen throughout the study. Key exclusion criteria 1. Lifetime history of Type 1 or Type 2 diabetes 2. Prior obesity treatment with surgery or a weight loss device. 3. Obesity caused by known endocrinologic disorders or by known congenital or acquired hypothalamic disease or monogenetic or syndromic forms of obesity. 4. Current or history of (within 3 months prior to screening) treatment with medications that may cause significant weight gain. 5. Family or personal history of MTC or MEN 2 6. Presence or history of malignant neoplasms within the past 5 years prior to screening
About the study
A study of ALV-100 to assess efficacy, safety and tolerability among participants with overweight or obesity who have previously achieved a body weight reduction of ≥10% while treated with incretin-based therapies.
What is being tested
- ALV-100 (drug)
- Placebo (drug)
Sponsor: Alveus Therapeutics, Inc. · Participants: 220 · Started: Aug 10, 2026
Contact the study team
- Study Director · Phone: +1 215-607-2243
Official record on ClinicalTrials.gov — NCT07837973
Locations in the U.S.
| Alabama | University of Alabama - Birmingham, Birmingham |
| Arizona | AMR Clinical, Tempe |
| California | Profound Research, Oceanside |
| Florida | Clinical Neuroscience Solutions, Orlando |
| Illinois | Christie Clinic, Champaign |
| Louisiana | BRCR Global Louisiana, Gretna |
| Michigan | Profound Research, Farmington Hills |
| New York | ALSA Research-Manhattan, New York |
| North Carolina | TMA Headlands, Wilmington |
| Oklahoma | Lynn Health Science Institute, Oklahoma City |
| Tennessee | AMR Clinical, Nashville |
| Utah | AMR Clinical, South Jordan |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.