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)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: (S)-pindolol benzoate, Semaglutide, Placebo to (S)-pindolol benzoate.
- Who it may be relevant to
- Registry conditions: Obesity, Muscle Loss. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Serbia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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)
Overview
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).
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 (like an X-ray). The study will also include measurements of weight, tests on the heart, and tests of muscle function. Questionnaires relating to health and well-being will also be used. Blood samples will be taken and tested to check overall health.
The study takes place in two parts, each lasting 20 weeks. Between each 20-week period) there is a 4-week 'wash-out' period during which patients will not receive any treatment.
ACM-001.1 (or placebo) is a tablet for oral administration (by mouth). Two doses of ACM-001.1 are being tested in this study. The semaglutide or sham injection will be administered once every week.
The study is 'double-blind', neither the patient or the doctor will know if the patient is taking ACM-001.1 or placebo or which dose they receive.
The total study is expected to run for approximately 18 months.
Interventions
- Drug (S)-pindolol benzoate
(S)-pindolol benzoate (ACM-001.1) immediate release tablet containing (S)-pindolol benzoate administered BID. - Drug Semaglutide
Semaglutide, solution for injection in pre-filled pen - Drug Placebo to (S)-pindolol benzoate
Placebo to ACM-001.1 immediate release tablet administered BID
Primary outcome measures
- The change in lean body mass (LBM) in patients receiving one of two doses of ACM-001.1 whilst also receiving semaglutide. [Time frame: 20 weeks]
- The change in lean body mass (LBM) grams/4 weeks over 20 weeks following semaglutide treatment. [Time frame: 20 weeks]
Secondary outcome measures (2)
- Changes in fat mass during and following semaglutide treatment [Time frame: 20 weeks]
- Muscle Strength (Handgrip strength) during and following semaglutide treatment [Time frame: 20 weeks]
Eligibility criteria
Inclusion criteria
Eligible for treatment with semaglutide.
Have a BMI of ≥30.0 kg/m².
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Serbia · 7 centers
- Clinical Hospital Center 'Dr Dragisa Misovic - Dedinje' — Belgrade
- Clinical Hospital Center Bezanijska kosa — Belgrade
- University Clinical Center of Serbia — Belgrade
- University Clinical Center Kragujevac — Kragujevac
- Klinika Za Endocrinologiju, Dijabetes I Bolesti Metabolizma — Niš
- University Clinical Center of Vojvodina — Novi Sad
- Opsta bolnica Pancevo — Pančevo
Identifiers
NCT: NCT07101939 · ACM-001-2024-01-CT