NCT06867718已完成2 期
A Phase 2 Study of Once-Daily RGT001-075 Compared With Placebo in Participants Who Have Obesity or Are Overweight With Weight-Related Comorbidities (COMO-1)
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 267
- 试验地点
- 47
- 主要终点
- Percent change from baseline in body weight at Week 36
研究概览
简要总结
This is a phase 2, 36-week randomized, double-blind, placebo-controlled, parallel arm study that will evaluate the safety, tolerability, weight loss efficacy, pharmacodynamic effects, and pharmacokinetics of RGT001-075 in adults who are obese (BMI ≥30 kg/m²) or who are overweight (BMI ≥27 kg/m²) with at least one weight-related comorbidity. RGT001-075 or matching placebo will be administered once daily.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age 18-75 years (inclusive) at the time of signing informed consent.
- •Hemoglobin A1c (HbA1c) <6.5% at screening.
- •BMI ≥30 kg/m².
- •BMI ≥27 kg/m² and <30 kg/m² with at least 1 weight-related comorbidity:
- •hypertension
- •dyslipidemia
- •cardiovascular (CV) disease
- •obstructive sleep apnea
- •Have a stable body weight (< 5% change) for the 3 months prior to randomization.
排除标准
- •(Obesity Related):
- •Have obesity induced by other endocrine disorders (for example, Cushing's syndrome) or diagnosed monogenetic or syndromic forms of obesity (for example, Melanocortin 4 Receptor deficiency or Prader-Willi Syndrome).
- •Have a prior or planned surgical treatment for obesity.
- •Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months before screening such as mucosal ablation, gastric artery embolization, intragastric balloon, duodenal-jejunal endoluminal liner.
- •Have been treated with prescribed or OTC drugs or alternative remedies that promote weight loss within the last 3 months before screening.
- •Exclusion Criteria (Medical Conditions)
- •Have a history of acute or chronic pancreatitis.
- •Have current symptomatic gallbladder disease or biliary disease.
- •Have known liver disease other than MASLD.
- •Have a known self or family history (first-degree relative) of multiple endocrine neoplasia type 2A or type 2B, thyroid C-cell hyperplasia, or medullary thyroid carcinoma (MTC).
- •Have a serum calcitonin ≥20 pg/mL.
- •Have an eGFR <30 mL/min/1.73 m², as determined by the central laboratory at screening.
- •Have a history of Major Depressive Disorder (MDD) or other severe psychiatric disorders (e.g., schizophrenia or bipolar disorder) within the last 2 years.
- •Have had any exposure to GLP-1 analogs, or other related compounds within the prior 3 months or any prior history of clinically significant side effects from GLP-1 receptor agonist (GLP-1 RA) or other related compounds containing GLP-1.
研究组 & 干预措施
RGT4
Experimental
Study Drug: RGT001-075 (Dose 4)
干预措施: RGT001-075 (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo Comparator (Drug)
RGT1
Experimental
Study Drug: RGT001-075 (Dose 1)
干预措施: RGT001-075 (Drug)
RGT2
Experimental
Study Drug: RGT001-075 (Dose 2)
干预措施: RGT001-075 (Drug)
RGT3
Experimental
Study Drug: RGT001-075 (Dose 3)
干预措施: RGT001-075 (Drug)
结局指标
主要结局
Percent change from baseline in body weight at Week 36
时间窗: Baseline and 36 weeks
Least Squares (LS) mean using mixed model repeated measures (MMRM)
次要结局
- Percent change from baseline in body weight at Week 26(Baseline and 26 weeks)
- Incidence of treatment emergent adverse events (TEAEs), TESAEs, TEAESIs overall(Baseline through week 36)
- Ambulatory Blood Pressure Monitoring (ABPM)(Baseline, 26 weeks)
- AUC0-last(week 15)
- AUC0-inf(week 15)
- Cmax(week15)
- Tmax(week 15)
- t1/2(week 15)
研究者
研究点 (47)
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