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RECRUITING
NCT07101939
PHASE2

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

View on ClinicalTrials.gov

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

Interventions

DRUG

(S)-pindolol benzoate

(S)-pindolol benzoate (ACM-001.1) immediate release tablet containing (S)-pindolol benzoate administered BID.

DRUG

Semaglutide

Semaglutide, solution for injection in pre-filled pen

DRUG

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