Phase 2a Study of Two Dose Levels of S-Pindolol Benzoate ACM-001.1 on Muscle Mass in Obese Adults Taking Semaglutide and After Stopping It

What this Trial Is About

Researchers are studying the effects of ACM-001.1, a drug taken alongside semaglutide, on muscle loss and muscle gain in adults with obesity. Semaglutide is already approved for weight management, but it can cause loss of muscle mass. This phase 2a study aims to assess how ACM-001.1 impacts lean body mass during and after semaglutide treatment in obese patients. The study consists of two 20-week parts separated by a 4-week break without treatment. Participants receive either semaglutide injections or sham fake injections weekly, alongside oral tablets of ACM-001.1 or placebo, taken twice daily. Two doses of ACM-001.1 are tested, and participants are randomly assigned to different groups in a crossover design to compare the effects during semaglutide therapy and after stopping semaglutide. Participants will undergo DEXA scans to measure body composition, heart tests, muscle function tests including handgrip strength, and complete health questionnaires. Blood samples will be collected to monitor overall health. The main outcome is the change in lean body mass during and after semaglutide treatment. The total study duration is about 18 months with close monitoring and questionnaires throughout.

A Study of the Effect of (S)-Pindolol Benzoate (ACM-001.1) on Lean Body Mass (LBM) in Obese Patents During (PROACT 1), and Post-semaglutide Therapy (PROACT 2)