2025-523104-71-00招募中3 期
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Once-Weekly RO7795068 Administered to Participants With Obesity or Overweight Without Type 2 Diabetes
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 754
- 试验地点
- 74
研究概览
简要总结
To evaluate the effect of RO7795068 compared with placebo on weight management with respect to Percent (%) change from baseline in body weight at Week 72
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years at the time of signing Informed Consent Form
- •Ability and willingness to comply with all aspects of the protocol including completion of all procedures, study visits, questionnaires, assessments for the duration of the study
- •Ability and willingness to self-administer the study drug (or receive an injection from a trained individual if visually impaired or with physical limitations)
- •Body mass index (BMI) ≥ 30.0 kg/m2 OR BMI ≥ 27.0 and <30.0 kg/m2 and diagnosed with at least one of the following weight-related comorbidities: – Prediabetes as defined by the 2025 American Diabetes Association (ADA) Standards of Medical Care in Diabetes, i.e., HbA1c 5.7–6.4% (39–47 mmol/mol) or fasting plasma glucose 100–125 mg/dL (5.6–6.9 mmol/L) as determined by laboratory test during screening – Hypertension: defined as current stable use (minimum 4 weeks prior to screening) of blood pressure lowering agents initiated for hypertension, or with systolic blood pressure ≥130 mm Hg or diastolic blood pressure ≥ 80 mm Hg during screening – Dyslipidemia: defined as current stable use (minimum 4 weeks prior to screening) of lipid-lowering agents initiated for dyslipidemia, or with low-density lipoprotein (LDL) ≥160 mg/dL (4.1 mmol/L) or triglycerides ≥150 mg/dL (1.7 mmol/L), or high-density lipoprotein (HDL) < 40 mg/dL (1.0 mmol/L) for men or HDL < 50 mg/dL (1.3 mmol/L) for women as determined by laboratory test during screening – Obstructive sleep apnea – Weight-related cardiovascular disease (including, but not limited to, ischemic cardiovascular disease, New York Heart Association (NYHA) Functional Class I-III heart failure)
- •History of ≥ 1 self-reported unsuccessful diet/exercise effort to lose body weight
- •Agreement to adhere to the contraception requirements
排除标准
- •History of Type 1 Diabetes Mellitus (T1DM) or T2DM, or history of ketoacidosis or hyperosmolar state/coma Prior, but not current, diagnosis of gestational diabetes is allowed if no history of diabetes is recorded since.
- •Self-reported change in body weight >5 kg within 3 months prior to screening
- •Obesity induced by other endocrinologic disorders (e.g., Cushing’s syndrome) or diagnosed monogenetic or syndromic forms of obesity (e.g., melanocortin 4 receptor deficiency or Prader-Willi syndrome)
- •Prior or planned surgical treatment for obesity Liposuction or abdominoplasty if performed more than 1 year prior to screening is allowed.
- •Known clinically significant gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction)
- •History of acute or chronic pancreatitis or clinically significant gallbladder disease History of acute pancreatitis caused by gallstones or clinically significant gallbladder disease is allowed if the participant had a cholecystectomy to resolve the problem at least 3 months prior to screening.
研究组 & 干预措施
RO7795068 Placebo
Placebo
干预措施: RO7795068 Placebo (Drug)
RO7795068, RO7795068, RO7795068, RO7795068, RO7795068, RO7795068
Test
干预措施: RO7795068 (Drug)
研究者
Trial Information System - TISL
Scientific
F. Hoffmann-La Roche AG
研究点 (74)
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