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)

Официальное название

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)

Обзор

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).

Подробное описание

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.

Вмешательства

• Препарат (S)-pindolol benzoate
  (S)-pindolol benzoate (ACM-001.1) immediate release tablet containing (S)-pindolol benzoate administered BID.
• Препарат Semaglutide
  Semaglutide, solution for injection in pre-filled pen
• Препарат Placebo to (S)-pindolol benzoate
  Placebo to ACM-001.1 immediate release tablet administered BID

Первичные конечные точки

• The change in lean body mass (LBM) in patients receiving one of two doses of ACM-001.1 whilst also receiving semaglutide. [Срок оценки: 20 weeks]
• The change in lean body mass (LBM) grams/4 weeks over 20 weeks following semaglutide treatment. [Срок оценки: 20 weeks]

Вторичные конечные точки (2)

• Changes in fat mass during and following semaglutide treatment [Срок оценки: 20 weeks]
• Muscle Strength (Handgrip strength) during and following semaglutide treatment [Срок оценки: 20 weeks]

Критерии участия

Критерии включения

Eligible for treatment with semaglutide.

Have a BMI of ≥30.0 kg/m².

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Сербия · 7 центров

• 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

Идентификаторы

NCT: NCT07101939 · ACM-001-2024-01-CT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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