← Back to all trials
Recruiting
NCT07837973
Study to Assess the Effect and Safety of ALV-100 on Maintenance of Weight Loss
Conditions: Overweight , Obesity, Adults
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 220
Sponsor: Alveus Therapeutics, Inc.
Location: University of Alabama - Birmingham Birmingham Alabama
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 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
Source: ClinicalTrials.gov (NCT07837973). StuddyBuddy aggregates publicly available trial information.