Recruiting
Phase 2

ALV-100

Sponsor:

Alveus Therapeutics, Inc.

Code:

NCT07837973

Conditions

Overweight , Obesity

Adults

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

ALV-100

Placebo

Study Details

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 semaglutide.

Conditions

Overweight , Obesity

Adults

Study ID

NCT07837973

Start date

Aug 10, 2026

Status verified date

Sep, 2026

Completion date

Aug 24, 2027

Anticipated

Primary completion date

Aug 24, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 semaglutide for weight management at a stable dose for at least 3 continuous months prior to screening.
4. Tolerating semaglutide at the discretion of the investigator
5. WL of at least 10% while on semaglutide 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

Study Design

Enrollment

220 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose A - Schedule 1

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

experimental: Dose B - Schedule 1

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

experimental: Dose C - Schedule 1

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

experimental: Dose A - Schedule 2

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

Interventions

ALV-100

Experimental drug

Placebo

Volume matched placebo

Primary outcome measure

  • Dose response of ALV-100 as assessed by maintenance of weight loss [ Time Frame: 24 weeks ]

Central Contacts and Locations

Central contacts

Locations

University of Alabama - Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Principal Investigator:

Garvey, MD

AMR Clinical

Recruiting

Tempe, Arizona, United States, 85281

Contacts

Principal Investigator:

Reedy, MD

Profound Research

Recruiting

Oceanside, California, United States, 92058

Contacts

Principal Investigator:

Lizotte, DO

Clinical Neuroscience Solutions

Recruiting

Orlando, Florida, United States, 32801

Contacts

Principal Investigator:

Miroshnikova, MD

Christie Clinic

Recruiting

Champaign, Illinois, United States, 61822

Contacts

Principal Investigator:

McCormick, DO

BRCR Global Louisiana

Recruiting

Gretna, Louisiana, United States, 70053

Contacts

Principal Investigator:

Nguyen, MD

Profound Research

Recruiting

Farmington Hills, Michigan, United States, 48334

Contacts

Principal Investigator:

Schmeltz, MD

ALSA Research-Manhattan

Recruiting

New York, New York, United States, 10016

Contacts

Principal Investigator:

Bhatt, MD

TMA Headlands

Recruiting

Wilmington, North Carolina, United States, 28403

Contacts

Principal Investigator:

Jones, MD

Lynn Health Science Institute

Recruiting

Oklahoma City, Oklahoma, United States, 73112

Contacts

Principal Investigator:

Griffin, MD

AMR Clinical

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Principal Investigator:

Bowles, MD, PC

AMR Clinical

Recruiting

South Jordan, Utah, United States, 84095

Contacts

Principal Investigator:

Andrews, DO

More Information

Sponsor

Alveus Therapeutics, Inc.

Last update posted

Sep 24, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by Alveus Therapeutics, Inc. on 2026-09-24. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.