Safety and Efficacy of ABBV-295 in Adults With Obesity or Overweight With Weight-Related Comorbidities

Официальное название

A Phase 2 Dose-Finding Study to Assess the Safety and Efficacy of ABBV-295 in Adults With Obesity or Overweight With Weight-Related Comorbidities

Обзор

Obesity is a condition where a person has excessive body fat, defined by a body mass index (BMI) of 30 kg/m2 or higher. The goal of this study is to evaluate the effect of various doses of ABBV-295 compared to placebo on reducing body weight at Week 32 in participants with obesity or overweight with weight-related comorbidities. ABBV-295 is an investigational long-acting amylin analog being developed for chronic weight management. Participants are placed into multiple treatment groups with different dosing paradigms of ABBV-295 or placebo. Participants will not know which treatment they are receiving, and there is a chance of being assigned to placebo. Adults with obesity or overweight (as defined by BMI) with weight-related comorbidities will be enrolled. Approximately 360 participants will be enrolled in the study at approximately 70 sites in the United States and Puerto Rico. Participants will receive subcutaneous (SC) injections of ABBV-295 solution for injection or matching placebo administered via pre-filled syringes for 52 weeks during the Double-Blind Period. There may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures. Participants will attend regular visits during the study at a hospital or clinic. The effects of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Вмешательства

• Препарат ABBV-295
  Subcutaneous
• Препарат Placebo
  Subcutaneous

Первичные конечные точки

• Percent Change From Baseline in Body Weight [Срок оценки: Baseline (Week 0) to Week 32]
• Number of Participants with Adverse Events (AEs) [Срок оценки: Up to approximately week 52]

Вторичные конечные точки (12)

• Percent Change From Baseline in Body Weight [Срок оценки: Baseline (Week 0) through Week 52]
• Change in Body Weight From Baseline [Срок оценки: Baseline (Week 0) through Week 32]
• Change in Body Weight From Baseline [Срок оценки: Baseline (Week 0) through Week 52]
• Change in Body Mass Index From Baseline [Срок оценки: Baseline (Week 0) through Week 32]
• Change in Body Mass Index From Baseline [Срок оценки: Baseline (Week 0) through Week 52]
• Change in Waist Circumference From Baseline [Срок оценки: Baseline (Week 0) through Week 32]
• Change in Waist Circumference From Baseline [Срок оценки: Baseline (Week 0) through Week 52]
• Percentage of Participants Who Achieve ≥5% Body Weight Reduction [Срок оценки: Week 32]
• Percentage of Participants Who Achieve ≥5% Body Weight Reduction [Срок оценки: Week 52]
• Percentage of Participants Who Achieve ≥10% Body Weight Reduction [Срок оценки: Week 32]
• Percentage of Participants Who Achieve ≥10% Body Weight Reduction [Срок оценки: Week 52]
• Percentage of Participants Who Achieve ≥15% Body Weight Reduction [Срок оценки: Week 32]

Критерии участия

Критерии включения

• BMI ≥ 30.0 kg/m2 at Screening (BMI is calculated as weight in kg divided by the square of height measured in meters) OR
• BMI ≥ 27.0 to < 30.0 kg/m2 at Screening (BMI is calculated as weight in kg divided by the square of height measured in meters) with at least one of the following weight-related comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease, metabolic dysfunction-associated steatotic liver disease (MASLD).

Критерии исключения

• Self-reported change in body weight ≥ 5% within 3 months prior to Screening
• Hemoglobin A1c (HbA1c) ≥ 6.5% (48 mmol/mol) at Screening
• Fasting glucose ≥126 mg/dL (7.0 mmol/L) or random glucose test ≥ 200 mg/dL (11.1 mmol/L)
• History of type 1 or type 2 diabetes mellitus
• Treatment with any medication or product used for obesity or weight management within 180 days prior to Screening Unstable or severe cardiovascular disease (e.g., myocardial infarction, stroke, hospitalization for: unstable angina pectoris, transient ischemic attack, or heart failure) within 180 days prior to Screening.
• The participant has a concurrent disease, condition, or is in a situation which, in the investigator's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study.

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

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07752979 · M25-998

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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