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)

Actimed Therapeutics

Status and phase: Enrolling; Phase 2

Conditions: Obesity; Muscle Loss

Treatments: Drug: Placebo to (S)-pindolol benzoate; Drug: (S)-pindolol benzoate; Drug: Semaglutide

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT07101939

ACM-001-2024-01-CT

Details and patient eligibility

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).

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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120 participants in 3 patient groups

Arm 1 semaglutide, low dose ACM-001.1 or sham injection/placebo during semaglutide therapy PROACT 1

Active Comparator group

Description:

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.

Treatment:

Drug: Semaglutide

Drug: (S)-pindolol benzoate

Drug: Placebo to (S)-pindolol benzoate

Arm 2 semaglutide, high dose ACM-001.1 or sham injection/placebo during semaglutide therapy PROACT 1

Active Comparator group

Description:

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.

Treatment:

Drug: Semaglutide

Drug: (S)-pindolol benzoate

Drug: Placebo to (S)-pindolol benzoate

Arm 3 ACM-001.1 low dose, high dose or placebo following semaglutide therapy PROACT 2

Active Comparator group

Description:

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

Treatment:

Drug: Semaglutide

Drug: (S)-pindolol benzoate

Drug: Placebo to (S)-pindolol benzoate