Study S001016

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)

ClinicalTrials.gov record

Registration

Registration: NCT07101939
Acronym: PROACT
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE2
Masking: QUADRUPLE
Status: RECRUITING
Enrollment: 120
Start: 2025-06-23
Primary completion: 2027-03
Lead sponsor: Actimed Therapeutics Ltd
Conditions: Obesity; Muscle Loss
Interventions: DRUG:(S)-pindolol benzoate; DRUG:Semaglutide; DRUG:Placebo to (S)-pindolol benzoate
Results posted: FALSE
Individual participant data sharing: UNDECIDED

Registered primary outcomes

The change in lean body mass (LBM) in patients receiving one of two doses of ACM-001.1 whilst also receiving semaglutide. [20 weeks]
The change in lean body mass (LBM) grams/4 weeks over 20 weeks following semaglutide treatment. [20 weeks]

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