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
Alveus Therapeutics, Inc.
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
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugALV-100
Experimental drug
- DrugPlacebo
Volume matched placebo
Locations (20)
- University of Alabama - BirminghamBirmingham, Alabama
- DM Clinical ResearchSun City, Arizona
- AMR ClinicalTempe, Arizona
- Profound ResearchOceanside, California
- DM Clinical ResearchBradenton, Florida
- DM Clinical ResearchDoral, Florida