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Clinical Trial NCT07101939 (PROACT) for Obesity, Muscle Loss is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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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) Phase 2 120
Clinical Trial NCT07101939 (PROACT) is designed to study Treatment for Obesity, Muscle Loss. It is a Phase 2 interventional study that is recruiting, having started on June 23, 2025, with plans to enroll 120 participants. Led by Actimed Therapeutics Ltd, it is expected to complete by March 1, 2027. The latest data from ClinicalTrials.gov was last updated on February 17, 2026.
Brief 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...Show More
Detailed Description
The study will compare the effects of ACM-001.1 (the study drug) when it is taken at the same time as semaglutide, and after semaglutide treatment has stopped. To allow the measurement of the effect of each treatment type, the study will involve the use of a placebo tablet and a 'sham' (fake) injection of semaglutide.
Various tests will be used to measure the effect of the study drug. These will include a DEXA scan ...
Show MoreOfficial 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)
Conditions
ObesityMuscle LossOther Study IDs
- PROACT
- ACM-001-2024-01-CT
NCT ID Number
Start Date (Actual)
2025-06-23
Last Update Posted
2026-02-17
Completion Date (Estimated)
2027-03
Enrollment (Estimated)
120
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
Keywords
semaglutide
s-pindolol
obesity
glp-1
glucagon-like peptide-1 receptor agonist
lean body mass
s-pindolol
obesity
glp-1
glucagon-like peptide-1 receptor agonist
lean body mass
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Crossover Assignment
Masking
Quadruple
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Active ComparatorArm 1 semaglutide, low dose ACM-001.1 or sham injection/placebo during semaglutide therapy PROACT 1 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. | (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 |
Active ComparatorArm 2 semaglutide, high dose ACM-001.1 or sham injection/placebo during semaglutide therapy PROACT 1 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. | (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 |
Active ComparatorArm 3 ACM-001.1 low dose, high dose or placebo following semaglutide therapy PROACT 2 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 | (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 |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
The change in lean body mass (LBM) in patients receiving one of two doses of ACM-001.1 whilst also receiving semaglutide. | In Arms 1 and 2: The change in lean body mass (LBM) grams/4 weeks over 20 weeks comparing 2 doses of ACM-001.1 with placebo. Body composition parameters will be measured using Dual Energy X-ray absorptiometry (DEXA) scan. | 20 weeks |
The change in lean body mass (LBM) grams/4 weeks over 20 weeks following semaglutide treatment. | In Arm 3: The change in lean body mass (LBM) grams/4 weeks over 20 weeks comparing 2 doses of ACM-001.1 with placebo. Body composition parameters will be measured using Dual Energy X-ray absorptiometry (DEXA) scan. | 20 weeks |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Changes in fat mass during and following semaglutide treatment | In Arms 1 \& 2: The change in fat mass (grams/4 weeks) over 20 weeks during semaglutide treatment comparing 2 doses of ACM-001.1 with placebo will be measured by DEXA scan.
In Arm 3: The change in fat mass (grams/4 weeks) following semaglutide therapy comparing 2 doses of ACM-001.1 with placebo will be measured by DEXA scan. | 20 weeks |
Muscle Strength (Handgrip strength) during and following semaglutide treatment | In Arms 1 \& 2: The change in Handgrip strength (kg/100g of arm lean mass) over 20 weeks comparing 2 doses of ACM-001.1 with placebo.
In Arm 3: The change in Handgrip strength (kg/100g of arm lean mass) over 20 weeks comparing 2 doses of ACM-001.1 with placebo. | 20 weeks |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Eligible for treatment with semaglutide.
Have a BMI of ≥30.0 kg/m².
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
Actimed Therapeutics LtdSCIRENT Clinical Research and Science d.o.o.Study Central Contact
Contact: Fabio Dorigotti, MD, +41 79 653 55 67, [email protected]
7 Study Locations in 1 Countries
Clinical Hospital Center 'Dr Dragisa Misovic - Dedinje', Belgrade, Serbia
Vladan Vukomanovic, Dr., Contact
Recruiting
Clinical Hospital Center Bezanijska kosa, Belgrade, Serbia
Marija Zdravkovic, Prof. Dr., Contact
Marija Zdravkovic, Prof. Dr, Principal Investigator
Recruiting
University Clinical Center of Serbia, Belgrade, Serbia
Vesna Dimitrijevic Sreckovic, Prof. Dr., Contact
Recruiting
University Clinical Center Kragujevac, Kragujevac, Serbia
Miodrag Sreckovic, Dr., Contact
Recruiting
Klinika Za Endocrinologiju, Dijabetes I Bolesti Metabolizma, Niš, Serbia
Sasa Radenkovic, Dr., Contact
Recruiting
University Clinical Center of Vojvodina, Novi Sad, Serbia
Milena Mitrovic, Prof. Dr., Contact
Recruiting
Opsta bolnica Pancevo, Pančevo, Serbia
Ana Kovacevic Kuzmanovic, Dr., Contact
Recruiting