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NCT07837973From ClinicalTrials.govRecruiting

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

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

  • Overweight , Obesity
  • Adults

At a glance

Phase
Phase 2
Study type
Interventional
Sponsor
Alveus Therapeutics, Inc.
Enrolment target
220
Started
10 August 2026
Main results due
24 August 2027
Study sites
12
Registry updated
28 September 2026

Can you take part?

  • Ages 18 years to 75 years.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the 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

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(12)

  • University of Alabama - Birmingham

    Birmingham, Alabama, United States

    Recruiting

  • AMR Clinical

    Tempe, Arizona, United States

    Recruiting

  • Profound Research

    Oceanside, California, United States

    Recruiting

  • Clinical Neuroscience Solutions

    Orlando, Florida, United States

    Recruiting

  • Christie Clinic

    Champaign, Illinois, United States

    Recruiting

  • BRCR Global Louisiana

    Gretna, Louisiana, United States

    Recruiting

  • Profound Research

    Farmington Hills, Michigan, United States

    Recruiting

  • ALSA Research-Manhattan

    New York, New York, United States

    Recruiting

  • TMA Headlands

    Wilmington, North Carolina, United States

    Recruiting

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, United States

    Recruiting

  • AMR Clinical

    Nashville, Tennessee, United States

    Recruiting

  • AMR Clinical

    South Jordan, Utah, United States

    Recruiting

Showing 12 of 12 sites. 12 of the 12 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07837973. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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