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)
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)
Actimed Therapeutics Ltd
120 participants
Jun 23, 2025
INTERVENTIONAL
Conditions
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).
Eligibility
Inclusion Criteria2
- Eligible for treatment with semaglutide.
- Have a BMI of ≥30.0 kg/m².
Exclusion Criteria8
- Type 2 diabetes mellitus who in the preceding 90 days have either:
- received a GLP-1RA (including semaglutide),
- had a hypoglycaemic event,
- lost >5 kg weight,
- had a HBA1C over 10.0%.
- Any cardiovascular event within previous 6 months, uncontrolled hypertension, known congestive heart failure, or angina during the past year
- Known severe chronic obstructive pulmonary disease (COPD)
- Concomitant use of beta blockers and patients with contra indications to beta blockers
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Interventions
(S)-pindolol benzoate (ACM-001.1) immediate release tablet containing (S)-pindolol benzoate administered BID.
Semaglutide, solution for injection in pre-filled pen
Placebo to ACM-001.1 immediate release tablet administered BID
Locations(7)
View Full Details on ClinicalTrials.gov
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NCT07101939