NCT07011797已完成2 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of CX11 Tablets in Overweight/Obese Participants
Corxel Pharmaceuticals34 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2025年6月17日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 34
- 主要终点
- Percentage change in body weight from baseline
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled Phase 2 clinical study:
- To evaluate the efficacy of different dose levels of CX11 tablets in body weight reduction as compared to placebo.
- To compare the changes of effects in weight and weight-related indicators at the visit time points.
- To evaluate the tolerability and safety of different doses of CX11 tablets in overweight/obese participants.
- To assess the pharmacokinetics (PK) of different doses of CX11 tablets in overweight/obese participants.
Overweight/obese participants who are successfully screened will be randomized in a 1:1:1:1:1 ratio to different doses of CX11 tablets or placebo. All participants will enter a 2-week follow-up period after 36 weeks of treatment for safety observation.
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
- •Participants who meet all of the following criteria will be eligible to participate in this study:
- •Between 18 and 75 years old. Both men and women can participate, but women may make up to 70% of the participants.
- •BMI of 30 or higher, or a BMI between 27 and 30 with at least one related health condition such as prediabetes, high blood pressure, abnormal cholesterol levels, fatty liver, or sleep apnea due to being overweight.
- •HbA1c level below 6.5% and fasting blood sugar levels below 126 mg/dL.
- •Have tried and failed to lose weight through diet and exercise at least once before the study and must have had a stable body weight (less than a 5% change) in the 90 days before the study.
- •Participants and their partners must not plan to become pregnant or donate sperm/eggs during the study and for 90 days after. They must agree to use effective contraception for at least 6 months prior to screening and continue their chosen contraception method throughout the study. Women who could become pregnant must have a negative pregnancy test 24 hours before the first dose of study drug.
- •Willing to maintain a stable diet and exercise routine during the study and keep a diary of their activities.
- •Understand the study procedures, be willing to follow the study rules strictly, and sign a consent form voluntarily.
排除标准
- •Participants who meet any of the following criteria will be excluded from this study:
- •Known or suspected hypersensitivity to GLP-1 receptor agonists or similar products.
- •Took part in another clinical study and received treatment within the last 90 days or within 5 drug elimination half-lives.
- •Any type of diabetes.
- •Obesity caused by hormonal or genetic issues such as thyroid problems, Cushing's syndrome, or other specific conditions.
- •Have had or plan to have obesity treatment surgery or use weight loss devices, with some exceptions if done over a year ago.
- •Have used certain medications or therapies for weight loss or conditions affecting weight, including GLP-1 receptor agonists and other related drugs, within the last 90 days.
- •Recent serious heart problems, uncontrolled high blood pressure, or certain ECG abnormalities.
- •History of pancreatitis, gallbladder disease (except for those treated with cholecystectomy), or evidence of hypothyroidism (except for participants who have normal thyroid function at screening and have been on a stable dose thyroid replacement for at least 90 days and are expected to maintain a stable dose during the study) or hyperthyroidism or thyrotoxicosis.
- •History of cancer in the last 5 years, except for localized basal or squamous skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer.
- •Serious gastrointestinal diseases or surgeries that affect drug absorption.
- •Active liver disease, excluding nonalcoholic fatty liver disease.
- •Other serious health conditions that could increase study risk or make participation inappropriate, including certain psychiatric disorders.
- •Recent history of unexplained fainting or family history of long QT syndrome or sudden death.
- •History of organ transplant or severe autoimmune diseases.
- •Had major surgery within the last 6 months or plan to have surgery soon.
- •Significant abnormalities in kidney function, liver enzymes, blood tests, or other specified lab results.
- •Positive for hepatitis B, hepatitis C, or HIV.
- •Donated blood, lost a lot of blood, or received a transfusion in the last 90 days.
- •Exceed weekly alcohol intake limits or have a history of drug abuse (including cannabis, its derivatives, or any cannabis-containing products; except for prescribed drug for medical purpose).
- •Women who are pregnant or breastfeeding.
- •Any other disease, condition, or medication that the investigator believes would interfere with the study.
研究组 & 干预措施
120 mg group
Experimental
干预措施: CX11 (Drug)
Placebo group
Placebo Comparator
干预措施: Placebo (Other)
200 mg fast titration group
Experimental
干预措施: CX11 (Drug)
200 mg slow titration group
Experimental
干预措施: CX11 (Drug)
160 mg group
Experimental
干预措施: CX11 (Drug)
结局指标
主要结局
Percentage change in body weight from baseline
时间窗: At Week 26
次要结局
- Proportion of participants achieving ≥ 5% body weight reduction from baseline(At Week 36)
- Percentage change in body weight from baseline(At Week 36)
- Proportion of participants achieving ≥ 10% body weight reduction from baseline(At Week 26 and Week 36)
- Change in body weight from baseline(At Week 26 and Week 36)
- Change in waist circumference from baseline(At Week 26 and Week 36)
- Change in body mass index (BMI) from baseline(At Week 26 and Week 36)
- Number of adverse events (AEs)(Study duration, approximately 38 weeks)
- Number of treatment-emergent adverse events (TEAEs)(Study duration, approximately 38 weeks)
- Number of AE of special interest (AESI)(Study duration, approximately 38 weeks)
- Number of serious adverse events (SAEs)(Study duration, approximately 38 weeks)
- Columbia-Suicide Severity Rating Scale [C-SSRS](At Day 1, Week 12, Week 26, Week 36 or at early termination (ET))
- Patient Health Questionnaire-9 [PHQ-9](At Day 1, Week 12, Week 26, Week 36 or at ET)
- Maximum steady-state plasma concentration (Cmax,ss)(Day 1 through Week 26)
- Minimum steady-state plasma concentration (Cmin,ss)(Day 1 through Week 26)
- Time to maximum steady-state plasma concentration (Tmax,ss)(Day 1 through Week 26)
- Area under the curve from 0 h to the time of the last quantifiable concentration (AUC0-last,ss)(Day 1 through Week 26)
- Area under the concentration-time curve over the dosing interval (AUC0-tau)(Day 1 through Week 26)
研究者
研究点 (34)
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