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NCT07837973PHASE2Recruiting

Study to Assess the Effect and Safety of ALV-100 on Maintenance of Weight Loss

Alveus Therapeutics, Inc.

Start Date

8/10/2026

Completion Date

8/24/2027

Summary

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.

Eligibility Criteria

Age Range: 18 years to 75 years

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

Interventions

DRUG

ALV-100

DRUG

Placebo

Interested in This Trial?

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Conditions

Overweight , ObesityAdults

Locations

University of Alabama - Birmingham

Birmingham, Alabama 35294

United States

AMR Clinical

Tempe, Arizona 85281

United States

Profound Research

Oceanside, California 92058

United States

Clinical Neuroscience Solutions

Orlando, Florida 32801

United States

Christie Clinic

Champaign, Illinois 61822

United States

BRCR Global Louisiana

Gretna, Louisiana 70053

United States

Profound Research

Farmington Hills, Michigan 48334

United States

ALSA Research-Manhattan

New York, New York 10016

United States

TMA Headlands

Wilmington, North Carolina 28403

United States

Lynn Health Science Institute

Oklahoma City, Oklahoma 73112

United States

AMR Clinical

Nashville, Tennessee 37203

United States

AMR Clinical

South Jordan, Utah 84095

United States