A Study of the Effect of (S)-Pindolol Benzoate (ACM-001.1) on Lean Body Mass (LBM) in Obese Patents During, and Post-semaglutide Therapy
- Conditions
- ObesityMuscle Loss
- Interventions
- Registration Number
- NCT07101939
- Lead Sponsor
- Actimed Therapeutics Ltd
- 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 and how much muscle mass is gained when a person continues taking ACM-001.1 but stops taking semaglutide.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 48
Eligible for treatment with semaglutide.
Have a BMI of ≥30.0 kg/m².
Key
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Arm 1 semaglutide, low dose ACM-001.1 or sham injection/placebo during semaglutide theapy (S)-pindolol benzoate 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. Arm 1 semaglutide, low dose ACM-001.1 or sham injection/placebo during semaglutide theapy Semaglutide 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. Arm 1 semaglutide, low dose ACM-001.1 or sham injection/placebo during semaglutide theapy Placebo to (S)-pindolol benzoate 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. Arm 2 semaglutide, high dose ACM-001.1 or sham injection/placebo during semaglutide therapy (S)-pindolol benzoate 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. Arm 2 semaglutide, high dose ACM-001.1 or sham injection/placebo during semaglutide therapy Semaglutide 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. Arm 2 semaglutide, high dose ACM-001.1 or sham injection/placebo during semaglutide therapy Placebo to (S)-pindolol benzoate 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. Arm 3 ACM-001.1 low dose, high dose or placebo following semaglutide therapy (S)-pindolol benzoate 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 Arm 3 ACM-001.1 low dose, high dose or placebo following semaglutide therapy Semaglutide 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 Arm 3 ACM-001.1 low dose, high dose or placebo following semaglutide therapy Placebo to (S)-pindolol benzoate 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
- Primary Outcome Measures
Name Time Method The change in lean body mass (LBM) in patients receiving one of two doses of ACM-001.1 whilst also receiving semaglutide. 20 weeks 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.
The change in lean body mass (LBM) grams/4 weeks over 20 weeks following semaglutide treatment. 20 weeks 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.
- Secondary Outcome Measures
Name Time Method Changes in fat mass during and following semaglutide treatment 20 weeks 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.Muscle Strength (Handgrip strength) during and following semaglutide treatment 20 weeks 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.
Trial Locations
- Locations (5)
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
Ubiversity Clinical Center of Vojvodina
🇷🇸Novi Sad, Serbia
Clinical Hospital Center 'Dr Dragisa Misovic - Dedinje'🇷🇸Belgrade, SerbiaVladan Vukomanovic, Dr.Contact