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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)
Sponsor: Actimed Therapeutics Ltd
Summary
Semaglutide is approved for weight management (weight loss and weight maintenance) in adult obese patients. Drug treatments like semaglutide that result in weight-loss can also decrease muscle mass. The purpose of this study is to investigate the effect of ACM-001.1 (the study drug) on how much muscle is lost when a person takes it with semaglutide (PROACT 1) and how much muscle mass is gained when a person continues taking ACM-001.1 but stops taking semaglutide (PROACT 2).
Official title: A Two-part, Phase 2a Randomized, Part Parallel-group, Double-blind Placebo-controlled Cross-over Multi-center Study to Evaluate the Effect of Two Dose Levels of (S)-Pindolol Benzoate (ACM-001.1) on Lean Body Mass in Obese Patients During (PROACT 1), and Post-semaglutide Therapy (PROACT 2)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2025-06-23
Completion Date
2027-03
Last Updated
2026-02-17
Healthy Volunteers
No
Conditions
Interventions
(S)-pindolol benzoate
(S)-pindolol benzoate (ACM-001.1) immediate release tablet containing (S)-pindolol benzoate administered BID.
Semaglutide
Semaglutide, solution for injection in pre-filled pen
Placebo to (S)-pindolol benzoate
Placebo to ACM-001.1 immediate release tablet administered BID
Locations (7)
Clinical Hospital Center 'Dr Dragisa Misovic - Dedinje'
Belgrade, Serbia
Clinical Hospital Center Bezanijska kosa
Belgrade, Serbia
University Clinical Center of Serbia
Belgrade, Serbia
University Clinical Center Kragujevac
Kragujevac, Serbia
Klinika Za Endocrinologiju, Dijabetes I Bolesti Metabolizma
Niš, Serbia
University Clinical Center of Vojvodina
Novi Sad, Serbia
Opsta bolnica Pancevo
Pančevo, Serbia