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A Two-part Phase 2a Study to Evaluate Two Doses of (S)-Pindolol Benzoate (ACM-001.1) on Lean Body Mass in Obese Patients During and After Semaglutide Therapy
Led by Actimed Therapeutics Ltd · Updated on 2026-02-17
120
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
Sponsors
A
Actimed Therapeutics Ltd
Lead Sponsor
S
SCIRENT Clinical Research and Science d.o.o.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the effects of ACM-001.1, a drug taken alongside semaglutide, on muscle loss and muscle gain in adults with obesity. Semaglutide is already approved for weight management, but it can cause loss of muscle mass. This phase 2a study aims to assess how ACM-001.1 impacts lean body mass during and after semaglutide treatment in obese patients. The study consists of two 20-week parts separated by a 4-week break without treatment. Participants receive either semaglutide injections or sham (fake) injections weekly, alongside oral tablets of ACM-001.1 or placebo, taken twice daily. Two doses of ACM-001.1 are tested, and participants are randomly assigned to different groups in a crossover design to compare the effects during semaglutide therapy and after stopping semaglutide. Participants will undergo DEXA scans to measure body composition, heart tests, muscle function tests including handgrip strength, and complete health questionnaires. Blood samples will be collected to monitor overall health. The main outcome is the change in lean body mass during and after semaglutide treatment. The total study duration is about 18 months with close monitoring and questionnaires throughout.
CONDITIONS
Brief Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eligible for treatment with semaglutide
- Have a body mass index (BMI) of 30.0 kg/m² or higher
- Aged between 18 and 75 years
- Able to provide informed consent
You will not qualify if you...
- Type 2 diabetes with any of the following in the past 90 days: use of GLP-1RA including semaglutide, hypoglycemic event, weight loss over 5 kg, HbA1C over 10.0%
- Cardiovascular event within the last 6 months
- Uncontrolled high blood pressure
- Known congestive heart failure or angina in the past year
- Severe chronic obstructive pulmonary disease (COPD)
- Current use of beta blockers or contraindications to beta blockers
- Any other condition that may affect study participation or safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 20 weeks per treatment period
Participants will receive two 20-week treatment periods of study drug tablets and weekly injections. In the first period, participants receive semaglutide injections and either low or high dose ACM-001.1 tablets or placebo. After a 4-week washout with no treatment, participants cross over to the opposite treatment for the second 20-week period.
Weekly visits for injections and assessments during each treatment period
Duration - 4 weeks
Participants do not receive any study treatments during this 4-week washout period between the two treatment periods.
No visits required for treatment
Trial Site Locations
Total: 7 locations
1
Clinical Hospital Center 'Dr Dragisa Misovic - Dedinje'
Belgrade, Serbia
Actively Recruiting
2
Clinical Hospital Center Bezanijska kosa
Belgrade, Serbia
Actively Recruiting
3
University Clinical Center of Serbia
Belgrade, Serbia
Actively Recruiting
4
University Clinical Center Kragujevac
Kragujevac, Serbia
Actively Recruiting
5
Klinika Za Endocrinologiju, Dijabetes I Bolesti Metabolizma
Niš, Serbia
Actively Recruiting
6
University Clinical Center of Vojvodina
Novi Sad, Serbia
Actively Recruiting
7
Opsta bolnica Pancevo
Pančevo, Serbia
Actively Recruiting
Research Team
F
Fabio Dorigotti, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
3
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