Efficacy and Safety of Aleniglipron in Participants With Obesity or Overweight With a Weight-Related Comorbidity (ACCOMPLISH-1)

Официальное название

A Randomized, Double-Blind, Placebo-Controlled, Pivotal Phase 3 Study to Evaluate the Long-Term Efficacy and Safety of Multiple Maintenance Doses of Once Daily Oral Aleniglipron for Chronic Weight Management in Adults With Obesity or Overweight and a Weight-Related Comorbidity

Обзор

Study GSBR-1290-12 is a Phase 3 pivotal, multicenter, global, randomized, placebo-controlled, double-blind study to investigate the long-term efficacy, safety, and tolerability of 3 maintenance doses of aleniglipron once daily (QD) compared with placebo, when used in combination with a reduced-calorie diet and increased physical activity. All participants will be randomized to at least 76 weeks of treatment to evaluate the effects on long term body weight changes, tolerability, and safety. In addition, the study will compare the effects between aleniglipron and placebo on blood pressure (BP), lipid parameters, patient-reported outcomes.

Вмешательства

• Препарат Aleniglipron
  Drug: aleniglipron administered orally Drug
• Препарат Placebo
  Drug: placebo administered orally

Первичные конечные точки

• Percent change in body weight from Baseline [Срок оценки: Baseline and Week 76]

Вторичные конечные точки (12)

• Change in body weight (absolute) from Baseline [Срок оценки: Baseline and week 76]
• Percentage of participants who achieve ≥5% reduction in body weight [Срок оценки: Baseline and week 76]
• Percentage of participants who achieve ≥10% reduction in body weight [Срок оценки: Baseline and week 76]
• Percentage of participants who achieve ≥15% reduction in body weight [Срок оценки: Baseline and week 76]
• Percentage of participants who achieve ≥20% reduction in body weight [Срок оценки: Baseline and week 76]
• Change in waist circumference from Baseline [Срок оценки: Baseline and week 76]
• Change in resting systolic blood pressure from Baseline [Срок оценки: Baseline and week 76]
• Percent change in fasting triglycerides and non-HDL cholesterol from Baseline [Срок оценки: Baseline and week 76]
• Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version physical function from Baseline [Срок оценки: Baseline and week 76]
• Change in HbA1c from Baseline [Срок оценки: Baseline and week 76]
• Change in body mass index from Baseline [Срок оценки: Baseline and week 76]
• Percent change in fasting total cholesterol from Baseline [Срок оценки: Baseline and week 76]

Критерии участия

Критерии включения

• Signed informed consent
• BMI ≥30 kg/m2 (obese) or BMI ≥27 kg/m2 (overweight) and presence of ≥1 of the obesity related comorbidities.

Критерии исключения

• Previously documented diagnosis of type 1 diabetes, type 2 diabetes, or any other type of diabetes.
• Self-reported change in body weight >5 kg within 3 months before Screening.
• Have prior or planned surgical or non-surgical treatment for obesity.
• Have or plan to have endoscopic and/or device-based therapy for obesity.
• Have obesity induced by other endocrine disorders.
• Impaired renal function at Screening
• Chronic malabsorption

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 71 центр

• ACCOMPLISH-1 Research Site — Birmingham
• ACCOMPLISH-1 Research Site — Birmingham
• ACCOMPLISH-1 Research Site — Phoenix
• ACCOMPLISH-1 Research Site — Sun City West
• ACCOMPLISH-1 Research Site — Tucson
• ACCOMPLISH-1 Research Site — Escondido
• ACCOMPLISH-1 Research Site — Gardena
• ACCOMPLISH-1 Research Site — La Jolla
• … и ещё 63 центра

Идентификаторы

NCT: NCT07654361 · GSBR-1290-12

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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