Muscle Loss, Obesity
Conditions
Keywords
semaglutide, s-pindolol, obesity, glp-1, glucagon-like peptide-1 receptor agonist, lean body mass
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 (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.
DRUGSemaglutide
Semaglutide, solution for injection in pre-filled pen
DRUGPlacebo to (S)-pindolol benzoate
Placebo to ACM-001.1 immediate release tablet administered BID
Sponsors
Actimed Therapeutics Ltd
SCIRENT Clinical Research and Science d.o.o.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
A two-part, randomized, part parallel-group, double-blind placebo-controlled cross-over multi-center study
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Key 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Serbia
Contacts
CONTACTFabio Dorigotti, MD
Outcome results
None listed