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

NCT07837973 | Recruiting Phase 2 FDA Drug

• 1 other identifier: ALV-101-1
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 12

Brief 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.

Conditions

Overweight , Obesity; Adults

Outcome Measures

Primary Outcomes (1)

• Dose response of ALV-100 as assessed by maintenance of weight loss

  Percentage change from baseline to Week 24 in BW

  24 weeks

Secondary Outcomes (8)

• Assess the safety and tolerability of ALV-100

  36 weeks

• Efficacy of ALV-100 compared to placebo as assessed by maintenance of weight loss

  24-36 weeks

• Change from baseline in glycemic control parameters

  24-36 weeks

• Change from baseline in lipid parameters

  24-36 weeks

• Change from baseline in vital signs

  24-36 weeks

Study Arms (4)

Dose A - Schedule 1

EXPERIMENTAL

Participants will receive ALV-100 or volume matched placebo during the treatment period

Drug: ALV-100; Drug: Placebo

Dose B - Schedule 1

EXPERIMENTAL

Participants will receive ALV-100 or volume matched placebo during the treatment period

Drug: ALV-100; Drug: Placebo

Dose C - Schedule 1

EXPERIMENTAL

Participants will receive ALV-100 or volume matched placebo during the treatment period

Drug: ALV-100; Drug: Placebo

Dose A - Schedule 2

EXPERIMENTAL

Participants will receive ALV-100 or volume matched placebo during the treatment period

Drug: ALV-100; Drug: Placebo

Interventions

ALV-100 DRUG

Experimental drug

Dose A - Schedule 1; Dose A - Schedule 2; Dose B - Schedule 1; Dose C - Schedule 1

Placebo DRUG

Volume matched placebo

Dose A - Schedule 1; Dose A - Schedule 2; Dose B - Schedule 1; Dose C - Schedule 1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult male and female participants, aged ≥18 to ≤75
• BMI ≥27 kg/m2 at screening.
• Has been treated with incretin-based therapy for weight management at a stable dose for at least 3 continuous months prior to screening.
• Tolerating incretin-based therapy at the discretion of the investigator
• WL of at least 10% while on incretin-based therapy and with stable BW for at least 3 months prior to screening.
• Willing to maintain their current general diet and physical activity regimen throughout the study.

You may not qualify if:

• Lifetime history of Type 1 or Type 2 diabetes
• Prior obesity treatment with surgery or a weight loss device.
• Obesity caused by known endocrinologic disorders or by known congenital or acquired hypothalamic disease or monogenetic or syndromic forms of obesity.
• Current or history of (within 3 months prior to screening) treatment with medications that may cause significant weight gain.
• Family or personal history of MTC or MEN 2
• Presence or history of malignant neoplasms within the past 5 years prior to screening

Sponsors & Collaborators

• Alveus Therapeutics, Inc.: lead

Study Sites (12)

University of Alabama - Birmingham

Birmingham, Alabama, 35294, United States

RECRUITING

AMR Clinical

Tempe, Arizona, 85281, United States

RECRUITING

Profound Research

Oceanside, California, 92058, United States

RECRUITING

Clinical Neuroscience Solutions

Orlando, Florida, 32801, United States

RECRUITING

Christie Clinic

Champaign, Illinois, 61822, United States

RECRUITING

BRCR Global Louisiana

Gretna, Louisiana, 70053, United States

RECRUITING

Profound Research

Farmington Hills, Michigan, 48334, United States

RECRUITING

ALSA Research-Manhattan

New York, New York, 10016, United States

RECRUITING

TMA Headlands

Wilmington, North Carolina, 28403, United States

RECRUITING

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

RECRUITING

AMR Clinical

Nashville, Tennessee, 37203, United States

RECRUITING

AMR Clinical

South Jordan, Utah, 84095, United States

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Study Director

CONTACT

+1 215-607-2243; clinicaltrials@alveustx.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 24, 2026
• Study Start: August 10, 2026
• Primary Completion (Estimated): August 24, 2027
• Study Completion (Estimated): August 24, 2027
• Last Updated: September 28, 2026

Record last verified: 2026-09

Locations

US (12)