Clinical Trials - Alveus Therapeutics

ALV-100 is an investigational drug. It has not been approved by the U.S. Food and Drug Administration (FDA). Taking part in a clinical study is voluntary.

Recruiting Phase 2

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

View on clinicaltrials.gov

Summary: To study the efficacy and safety of ALV-100 compared with placebo for maintenance of weight loss in people previously treated with semaglutide or tirzepatide.
Official title: This is a randomized, double-blind, placebo-controlled study. Participants are assigned by chance to one of four ALV-100 dose regimens or placebo for 24 weeks.
Basic eligibility: Adults with obesity or overweight who have lost weight with semaglutide or tirzepatide and whose weight has stabilized. People who have had prior obesity treatment with surgery or a weight loss device are not eligible. Additional criteria apply.
Locations: Alabama, Arizona, California, Florida, Georgia, Illinois, Louisiana, Michigan, New York, North Carolina, Oklahoma, Tennessee, Texas, Utah.

Clinicaltrial.gov ID: NCT07837973
Phase: Phase 2
Enrollment (Estimated): 220
Study Start (Actual): 2026-08-10
Study Completion (Estimated): 2027-08-24
Last update posted: 2026-10-26

Active Phase 1b

Study of ALV-100 to Assess Safety, Tolerability, and PK/PD in Overweight/Obese Participants With or Without Type 2 Diabetes

View on clinicaltrials.gov

Summary: To assess the safety, tolerability, pharmacokinetics (how the body processes the drug), and pharmacodynamics (how the drug affects the body) of ALV-100 in adults with overweight or obesity, with or without type 2 diabetes.
Official title: This is a randomized, double-blind, placebo-controlled study. Participants receive increasing doses of ALV-100 or a matching placebo.
Basic eligibility: Adults aged 18 to 65 with a body mass index (BMI) of 27.0 to 39.9. Additional criteria apply.
Locations: Miami, Florida, Columbus, Ohio, San Antonio, Texas.

Clinicaltrial.gov ID: NCT07399678
Phase: Phase 1b
Enrollment (Estimated): 180
Study Start (Actual): 2025-12-29
Study Completion (Estimated): 2027-10
Last update posted: 2026-10-26

For more information

Full study details, including additional eligibility criteria and study site contacts, are available on ClinicalTrials.gov by searching the study ID, or through the links provided in this page.

Phone Number +1 215-607-2243

Email Contact the study team

Please talk with your healthcare provider about whether a clinical study may be right for you.