Weight-loss maintenance with ALV-100 after prior weight loss

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2, randomized, placebo-controlled trial evaluates the safety and tolerability of ALV-100 for maintaining weight loss in adults with overweight or obesity who previously reduced their weight by at least 10% while on incretin-based therapy. Eligible participants are 18 to 75 years old, have BMI ≥23 kg/m2, and have been on a stable dose of incretin therapy for at least 3 months with continued weight stability. Participants will be assigned to receive ALV-100 or placebo and monitored for weight maintenance, safety, and tolerability while maintaining their usual diet and activity. Primary outcomes focus on weight maintenance and adverse events; secondary outcomes may include metabolic measures and quality of life. The trial is sponsored by Alveus Therapeutics, with sites in Alabama and Arizona.

Why it matters

Who can join: the full rules

Key inclusion criteria

1. Adult male and female participants, aged ≥18 to ≤75
2. BMI ≥23 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

Where it's running

• University of Alabama - Birmingham
  Birmingham, Alabama, United States Recruiting
• DM Clinical Research
  Sun City, Arizona, United States Recruiting
• AMR Clinical
  Tempe, Arizona, United States Recruiting
• Profound Research
  Oceanside, California, United States Recruiting
• DM Clinical Research
  Bradenton, Florida, United States Recruiting
• DM Clinical Research
  Doral, Florida, United States Recruiting

Study contacts

• Study coordinator: Study Director
• Email: clinicaltrials@alveustx.com
• Phone: +1 215-607-2243

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.