Study of Olatorepatide in Adult Participants Living With Overweight or Obesity Without Diabetes

Официальное название

A Phase 2, Randomized, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of Olatorepatide, a GLP-1/GIP Receptor Agonist, With Different Doses and Drug-Titration Algorithms in Participants Living With Overweight or Obesity

Обзор

This study will test an experimental drug called olatorepatide ("study drug") to determine how safe and effective this drug is compared to placebo and how easily the body can accept this drug at different doses and dosing schedules without causing side effects, as well as how the drug is processed in the body by participants with overweight or obesity but do not have diabetes. The study is looking at: * What side effects the study drug might cause * How much study drug is in the blood at different times * How well the study drug works * What effects the study drug may have on the body at different dosing schedules * If the body makes antibodies to the study drug as this may cause the study drug to not work as well

Вмешательства

• Препарат Olatorepatide
  Administered per the protocol
• Препарат Placebo
  Administered per the protocol

Первичные конечные точки

• Occurrence of Treatment-Emergent Adverse Events (TEAEs) [Срок оценки: Up to approximately 60 weeks]
• Severity of TEAEs [Срок оценки: Up to approximately 60 weeks]
• Percent change in body weight [Срок оценки: From baseline to week 52]

Вторичные конечные точки (3)

• Olatorepatide concentrations [Срок оценки: Up to approximately 60 weeks]
• Occurrence of Anti-Drug Antibody (ADA) to olatorepatide [Срок оценки: Up to approximately 52 weeks]
• Magnitude of ADA to olatorepatide [Срок оценки: Up to approximately 52 weeks]

Критерии участия

Критерии включения

• Body Mass Index (BMI) ≥30.0 kg/m\^2 to <45.0 kg/m\^2 at screening OR
• BMI ≥27.0 kg/m\^2 at screening with at least 1 of the following weight-related co-morbidities: Hypertension, Dyslipidemia, Prediabetes, established Obstructive Sleep Apnea (OSA), established Coronary Artery Disease (CAD), Heart failure, established cerebrovascular disease as described in the protocol

Критерии исключения

• Previous or current diagnosis of Type 1 or Type 2 diabetes at screening
• Change in body weight >5 kg within approximately 3 months before screening as described in the protocol
• Bariatric surgery, including any procedures to revise, reverse, or remove any previous bariatric surgery interventions as described in the protocol
• History of acute or chronic pancreatitis, cholecystitis, or symptomatic gallbladder stones
• History or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2

Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply

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: NCT07685808 · HS-20094-OB-25106

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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