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)
Recruiting · NCT07101939 · Interventional (participants receive a specific treatment) · Lead sponsor: Actimed Therapeutics Ltd
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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).
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Eligible for treatment with semaglutide.
- Have a BMI of ≥30.0 kg/m².
- Key
Exclusion criteria
- 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
Where it is running
7 locations listed.
- Clinical Hospital Center 'Dr Dragisa Misovic - Dedinje' - Belgrade, Serbia
- Clinical Hospital Center Bezanijska kosa - Belgrade, Serbia
- University Clinical Center of Serbia - Belgrade, Serbia
- University Clinical Center Kragujevac - Kragujevac, Serbia
- Klinika Za Endocrinologiju, Dijabetes I Bolesti Metabolizma - Niš, Serbia
- University Clinical Center of Vojvodina - Novi Sad, Serbia
- Opsta bolnica Pancevo - Pančevo, Serbia