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, and Post-semaglutide Therapy (PROACT)
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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 and how much muscle mass is gained when a person continues taking ACM-001.1 but stops taking semaglutide.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Eligible for treatment with semaglutide.
• Have a BMI of ≥30.0 kg/m².
Locations
Other Locations
Serbia
Clinical Hospital Center 'Dr Dragisa Misovic - Dedinje'
RECRUITING
Belgrade
Clinical Hospital Center Bezanijska kosa
RECRUITING
Belgrade
University Clinical Center of Serbia
RECRUITING
Belgrade
University Clinical Center Kragujevac
RECRUITING
Kragujevac
Ubiversity Clinical Center of Vojvodina
RECRUITING
Novi Sad
Contact Information
Primary
Fabio Dorigotti, MD
info@actimedtherapeutics.com
+41 79 653 55 67
Time Frame
Start Date: 2025-06-23
Estimated Completion Date: 2026-09
Participants
Target number of participants: 48
Treatments
Active_comparator: Arm 1 semaglutide, low dose ACM-001.1 or sham injection/placebo during semaglutide theapy
Patients in Arm 1 will be randomized to a crossover design, to receive either semaglutide and low dose ACM-001.1 BID or a sham injection and placebo ACM-001.1 BID during Period 1. Following washout, in Period 2 patients within Arm 1 and Arm 2 will cross-over onto the opposing treatment.
Active_comparator: Arm 2 semaglutide, high dose ACM-001.1 or sham injection/placebo during semaglutide therapy
Patients in Arm 2 will be randomized to a crossover design, to receive either semaglutide and high dose ACM-001.1 BID (Group 2a) or a sham injection and placebo ACM-001.1 BID (Group 2b) during Period 1. Following washout, in Period 2 patients within Arm 1 and Arm 2 will cross-over onto the opposing treatment.
Active_comparator: Arm 3 ACM-001.1 low dose, high dose or placebo following semaglutide therapy
Patients randomized to Arm 3 will receive semaglutide and placebo ACM-001.1 BID during Period 1. Patients in Arm 3 will be further randomised into one of three treatment groups for Period 2:~Group 3a will receive a sham injection and low dose ACM-001.1 BID Group 3b will receive a sham injection and high dose ACM-001.1 BID Group 3c will receive a sham injection and Placebo ACM-001.1 BID
Related Therapeutic Areas
Sponsors
Collaborators: SCIRENT Clinical Research and Science d.o.o.
Leads: Actimed Therapeutics Ltd