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).
None
received a GLP-1RA (including semaglutide),
had a hypoglycaemic event,
lost >5 kg weight,
had a HBA1C over 10.0%.
Crossover
(S)-pindolol benzoate
Drug(S)-pindolol benzoate (ACM-001.1) immediate release tablet containing (S)-pindolol benzoate administered BID.
Semaglutide
DrugSemaglutide, solution for injection in pre-filled pen
Placebo to (S)-pindolol benzoate
DrugPlacebo to ACM-001.1 immediate release tablet administered BID
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.
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.
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.
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.
An evaluation of changes in body weight during and following semaglutide treatment
In Arms 1 \& 2: An evaluation of changes in body weight (kg/4 weeks) as the change from baseline (Period 1) over 20 weeks comparing 2 doses of ACM-001.1 with placebo. In Arm 3: An evaluation of changes in body weight (kg/4 weeks) as the change from baseline at the end of semaglutide therapy comparing 2 doses of ACM-001.1 with placebo.
Change in lean body mass (LBM) at the end of semaglutide therapy comparing 2 doses of ACM-001.1 with placebo
In Arm 3: The change in lean body mass (LBM) (g/4 weeks) after completing a period of 20 weeks of semaglutide therapy (plus placebo) comparing 2 doses of ACM-001.1 with placebo
Evaluation of hip:waist ratio during and following semaglutide treatment
In Arms 1 \& 2: An evaluation of changes in hip:waist ratio (each circumference measured in cm) as the change from baseline (Period 1) over 20 weeks comparing 2 doses of ACM-001.1 with placebo. In Arm 3: An evaluation of changes in hip:waist ratio (each circumference measured in cm) as the change from baseline at the end of semaglutide therapy comparing 2 doses of ACM-001.1 with placebo.
Change in body composition (bone mineral composition) during and following semaglutide treatment
In Arms 1 \& 2: An evaluation of changes in body composition (bone mineral composition (grams/4 weeks)) as the change from baseline (Period 1) over 20 weeks comparing 2 doses of ACM-001.1 with placebo. In Arm 3: An evaluation of changes in body composition (bone mineral composition (grams/4 weeks)) as the change from baseline at the end of semaglutide therapy comparing 2 doses of ACM-001.1 with placebo.
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Actimed Therapeutics Ltd
Lead sponsor
SCIRENT Clinical Research and Science d.o.o.
Collaborator
