A Randomized, Double-Blind, Placebo-Controlled Phase III Study to Assess the Efficacy and Safety of CG-DL (Korglutide) in Weight Management in Obese Individuals with and without Type 2 Diabetes
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- To evaluate the efficacy of Korglutide compared to placebo in inducing weight loss over a 12-week treatment period in obese individuals with and without Type 2 diabetes.
研究概览
简要总结
The proposed study is a multi-centre, randomized, double-blind, placebo-controlled, parallelgroup clinical trial. The trial will enrol a total of 100 subjects, divided into two distinct cohorts.
The first cohort will consist of obese subject without a diagnosis of diabetes, while the second cohort will include obese individuals who have been diagnosed with Type 2 Diabetes Mellitus (T2DM). Each cohort will include 50 subjects, and both groups will receive either the investigational medicinal product, Korglutide, or a matching placebo.
The total duration of the study for each subject will be approximately 16 weeks. This will be divided into three main phases: a screening period lasting up to two weeks, a treatment period spanning 12 weeks, and a final follow-up period of two weeks after the treatment phase.
During the treatment phase, subjects will be administered Korglutide or placebo once daily. The drug will be provided in sachet form, dissolved in water, and consumed orally, as this is the intended method of administration for Korglutide. Subjects in the treatment group will receive the active drug, while those in the control group will receive a matching placebo that mimics the appearance and taste of Korglutide. The specific dosage will be determined based on prior studies,
with adjustments made to ensure both safety and efficacy in this patient population.
Randomization will occur on a 1:1 ratio, with half of the subjects in each cohort receiving Korglutide and the other half receiving placebo. Stratification will occur based on two key factors:
first, by cohort (obese individuals without diabetes vs. obese individuals with T2DM), and second, by baseline Body Mass Index (BMI), with subjects stratified into three categories—BMI of 30– 34.9 kg/m², BMI of 35–39.9 kg/m², and BMI of 40 kg/m² or greater.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Adults male and female subjects aged 18 to 65 years at the time of screening 2.Body Mass Index BMI Non-diabetic cohort BMI more than equal to 30 kg per meter square Diabetic cohort Type 2 Diabetes BMI more than equal to 27 kg per meter square 3.Type 2 Diabetes Mellitus Diabetic Cohort Diagnosed at least 6 months prior to screening Glycated hemoglobin HbA1c between 7.0 percent and 10.0 Percent at screening.
- •On a stable regimen of oral antidiabetic drugs OADs or insulin for at least 3 months before randomization.
- •Demonstrates a stable body weight Pulse or Minus 5 kg for at least 3 months before screening
- •Waist Circumference more than equal to 88 cm in women; more than equal to 102 cm in men.
- •Must follow a calorie-controlled diet and be willing to adhere to physical activity recommendations during the trial.
- •Subjects must provide signed and dated informed consent before screening procedures.
排除标准
- •Women who are pregnant, planning to become pregnant during the study, or currently breastfeeding will be excluded.
- •Female subjects of childbearing potential must have a negative pregnancy test at screening and must agree to use effective contraception throughout the duration of the study.
- •If a subject becomes pregnant during the study, she will be discontinued immediately, and appropriate follow-up procedures will be initiated to ensure safety.
- •Subjects with Type 1 Diabetes Mellitus will be excluded due to the differing metabolic mechanisms and treatment goals from those with Type 2 Diabetes Mellitus T2DM.
- •Subjects with a history of major cardiovascular events, including myocardial infarction, stroke, unstable angina, or heart failure NYHA Class III or IV in the past 6 months, will be excluded.
- •This ensures patient safety, as weight loss medications may have cardiovascular effects.
- •Individuals with uncontrolled hypertension systolic blood pressure more than 180 mmHg or diastolic blood pressure more than 100 mmHg will be excluded.
- •Properly managed blood pressure is essential, as fluctuations may complicate the trial.
- •Those with a history of eating disorders, such as anorexia nervosa, bulimia, or binge-eating disorder, will be excluded, as participation in a weight loss trial may exacerbate disordered eating behaviours.
- •Subjects with significant liver or kidney dysfunction, such as cirrhosis or end-stage renal disease eGFR less than 30 mL per min per 1.73 meter square, will be excluded due to the potential risks of drug accumulation and impaired metabolism of Korglutide.
- •Subjects who have undergone bariatric surgery or are planning to undergo such surgery during the study will be excluded.
- •Surgical interventions for weight loss could confound the trials outcomes.
- •Endocrine tumours Multiple endocrine neoplasia, type 2 MEN 2 or if someone in your family had these tumours.
- •Individuals who have used weightloss medications such as phentermine, orlistat, liraglutide or participated in structured weight loss programs within 3 months before screening will be excluded to ensure the effects observed are from Korglutide alone.
- •Subjects with a history of acute or chronic pancreatitis and Gallbladder diseases will be excluded.
- •Certain weight loss drugs have been associated with an increased risk of pancreatitis, and this risk must be minimized.
- •This is to avoid complicating factors from cancer treatments or the disease itself.
- •Subjects with severe psychiatric disorders such as major depression, schizophrenia, or active substance abuse will be excluded, as these conditions could interfere with adherence to the study protocol and accurate reporting of adverse effects.
- •Subjects who have taken any investigational drug or participated in another clinical trial within the past 30 days will be excluded.
- •This prevents interference from other untested treatments.
- •Subjects with known hypersensitivity to Korglutide or any of its components will be excluded from the trial to prevent adverse reactions.
- •Individuals with chronic gastrointestinal conditions like Crohns disease, ulcerative colitis, or irritable bowel syndrome that could affect nutrient absorption or metabolism will be excluded, as these conditions may interfere with the outcomes.
- •Subjects with a recent history within 12 months of alcohol or drug abuse will be excluded.
- •These conditions could compromise the subject’s ability to follow the study protocol or affect the study outcomes.
- •Individuals with severe hyperlipidaemia triglycerides more than 500 mg per dL that is uncontrolled by medication or diet will be excluded due to potential cardiovascular risks during the study.
- •Subjects who, in the investigators opinion, are unlikely to adhere to the study protocol e.g., non-compliance with treatment, frequent travel, or other significant life events will be excluded to maintain the integrity of the data collected.
结局指标
主要结局
To evaluate the efficacy of Korglutide compared to placebo in inducing weight loss over a 12-week treatment period in obese individuals with and without Type 2 diabetes.
时间窗: The primary efficacy endpoint will be the percent change in body weight from baseline to the end of the treatment period Baseline to Week 12.
次要结局
- 1. Proportion of Subjects Achieving more than equal to 5 percent Weight Loss.(Week 12)
- 2. Proportion of Subjects Achieving more than 10 percent Weight Loss.(Week 12)
- 3. Change in Waist Circumference.(Baseline, Week 12)
- 4.Changes in HbA1c for Diabetic Cohort.(Baseline, Week 12)
- 5. Changes in Fasting Plasma Glucose.(Baseline, Week 12)
- 6. Changes in Lipid Profile(Baseline, Week 12)
- 7. Changes in Blood Pressure(Baseline, Week 12)
研究者
Dr Aditi Datta
Biosite Research Private Limited