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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Dose response of ALV-100 as assessed by maintenance of weight loss — 24 weeks Percentage change from baseline to Week 24 in BW
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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