NCT07505303进行中（未招募）2 期
A Phase 2a, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of ECC4703 as an Adjunct to Semaglutide in Adults With Obesity
Eccogene15 个研究点 分布在 1 个国家目标入组 151 人开始时间: 2026年3月23日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 151
- 试验地点
- 15
研究概览
简要总结
The primary objective of this trial is to evaluate the effect of oral ECC4703 on body weight reduction and in a sub-study on liver fat content as assessed by change in magnetic resonance imaging proton density fat fraction (MRI-PDFF) at Week 20.
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
- Triple (Participant, Care Provider, 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
- 是
入选标准
- •Capable of providing written informed consent and complying with all trial procedures.
- •Willing to comply with contraception requirements (as applicable to males and females of childbearing potential).
- •Obese with BMI ≥30 kg/m^2 and stable body weight within 6 months prior to screening.
- •HbA1c ≤6.5%.
- •Estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m^2 (per CKD-EPI 2021 formula).
- •If participant consents to enter the imaging substudy, has liver fat content by MRI-PDFF >8% at baseline (Week 9).
排除标准
- •History or current diagnosis of type 1 or type 2 diabetes mellitus.
- •Weight change >5% of total body weight within 6 months prior to screening or planned initiation of a weight loss program or use of weight-altering medication.
- •Obesity induced by endocrine disorders such as Cushing's syndrome or monogenic or syndromic obesity such as Prader-Willi syndrome.
- •Use of GLP-1 agonist treatment within the last 6 months prior to screening.
- •History or current evidence of a pituitary disorder.
- •Have current treatment with or history (within 3 months prior to screening) of treatment with medications that may cause significant weight gain.
- •ALT or AST >1.5×ULN, or ALP >1.5×ULN at screening.
- •Documented evidence or clinical signs/symptoms of advanced liver disease including liver cirrhosis, portal hypertension, or hepatic decompensation.
- •History of significant alcohol consumption for >3 consecutive months within a year prior to screening.
- •Current or past therapy with THR-β agonists (eg, resmetirom).
- •Active untreated hyperthyroidism or hyperthyroidism currently treated with antithyroid medications including methimazole or propylthiouracil.
- •Clinically significant thyroid dysfunction including uncontrolled hypothyroidism or hyperthyroidism.
- •History of bariatric surgery, fitting of a weight loss device, or intestinal bypass surgery within 5 years prior to screening.
- •History of major surgery within 8 weeks prior to screening.
- •Clinically relevant acute or chronic medical condition or unstable disease of the cardiovascular, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic, psychiatric, immune or dermatologic system.
研究者
研究点 (15)
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