NCT06628362进行中（未招募）2 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of Once-Weekly CT-388 Administered Subcutaneously for 48 Weeks to Participants Who Are Overweight or Obese With Type 2 Diabetes Mellitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 447
- 试验地点
- 70
- 主要终点
- Percent Change in Body Weight from Baseline to Week 36
研究概览
简要总结
This is a multi-center, randomized, double-blind, placebo-controlled, parallel group dose-finding study to evaluate the efficacy and safety of enicepatide at low, middle, and high doses in participants who are overweight or obese with Type 2 diabetes mellitus (T2DM).
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, 18 to 75 years of age
- •Body mass index (BMI) ≥25.0 kg/m^2
- •Have a diagnosis of Type 2 Diabetes Mellitus (T2DM) according to the World Health Organization classification or other locally applicable standards
- •Have an HbA1c ≥7% and ≤10.5%
- •Management of T2DM with diet and exercise alone, metformin, or a sodium-glucose cotransporter-2 (SGLT-2) inhibitor, as monotherapy or in combination, per approved local label
- •At least one self-reported unsuccessful diet/exercise effort to lose body weight
排除标准
- •Have Type 1 Diabetes Mellitus (T1DM), history of ketosis or hyperosmolar state/coma, or any other types of diabetes except T2DM
- •Have had 1 or more episodes of Level 3 hypoglycemia or have had hypoglycemia unawareness within 3 months prior to screening
- •Have history or presence of proliferative diabetic retinopathy, diabetic macular edema, or non-proliferative diabetic retinopathy that requires acute treatment
- •Have evidence of clinically significant autonomic neuropathy (symptoms may include resting tachycardia, orthostatic hypotension, or diabetic diarrhea)
- •Had treatment with any oral antihyperglycemic medications, with the exception of metformin or SGLT-2 inhibitors, within 3 months prior to screening or planned concurrent treatment with these medications during the study
- •Had treatment with injectable antihyperglycemic medication, with the exception of short-term insulin, within 6 months prior to screening or planned concurrent treatment with these medications during the study
- •Self-reported body weight change of >5 kg within 3 months before screening
- •Any unbalanced/extreme diets, such as very low calorie, low carbohydrate, very high protein, ketogenic, or intermittent diets, within 3 months of the screening visit, or plan to be on such diets during the study
- •Current or recent use of any treatment that promotes weight loss or glucose metabolism
- •Current or recent use of treatment that may cause weight gain
- •Prior or planned surgical treatment or procedure for obesity, except for liposuction or abdominoplasty if performed >1 year prior to screening. Participants with a history of devices, such as LAP-BAND® or intragastric balloon, are permitted, if devices were removed >1 year prior to screening.
- •History of clinically significant or active gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction, intestinal obstruction), or chronic use of medications that directly affect GI motility
- •History of chronic pancreatitis or acute pancreatitis or have signs and symptoms of acute pancreatitis at screening
- •Have obesity induced by other endocrinologic disorders (e.g., Cushing syndrome) or diagnosed monogenetic or syndromic forms of obesity
- •History or diagnosis of significant active or unstable major depressive disorder or any history/diagnosis of other severe psychiatric conditions (e.g., schizophrenia; bipolar disorder; other serious mood disorder or anxiety disorder, or hyperactivity disorder) within the last year before screening
- •History of any hematologic conditions that may interfere with HbA1c measurement (e.g., hemolytic anemias, sickle cell disease, other hemoglobinopathies)
- •Family or personal history of medullary thyroid carcinoma
- •Women who are pregnant, breastfeeding, or intend to become pregnant, or are of childbearing potential and not using a highly effective contraceptive method as required per protocol
研究组 & 干预措施
Arm 1: Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Arm 3: Enicepatide Dose Level 2
Experimental
干预措施: Enicepatide (Drug)
Arm 4: Enicepatide Dose Level 3
Experimental
干预措施: Enicepatide (Drug)
Arm 5: Enicepatide Dose Level 4 (High)
Experimental
干预措施: Enicepatide (Drug)
Arm 2: Enicepatide Dose Level 1 (Low)
Experimental
干预措施: Enicepatide (Drug)
结局指标
主要结局
Percent Change in Body Weight from Baseline to Week 36
时间窗: Baseline to Week 36
Change in Glycated Hemoglobin (HbA1c) from Baseline to Week 36
时间窗: Baseline to Week 36
次要结局
- Percent Change in Body Weight from Baseline to Week 48(Baseline to Week 48)
- Change in HbA1c from Baseline to Week 48(Baseline to Week 48)
- Percentage of Participants with HbA1c <7.0% at Weeks 36 and 48(Weeks 36 and 48)
- Percentage of Participants with Body Weight Reduction ≥5%, ≥10%, ≥15%, ≥20%, and ≥25% from Baseline to Week 36(Baseline and Week 36)
- Percentage of Participants with Body Weight Reduction ≥5%, ≥10%, ≥15%, ≥20%, and ≥25% from Baseline to Week 48(Baseline and Week 48)
- Percent Change in Body Weight from Baseline to Week 28(Baseline and Week 28)
- Absolute Change in Body Weight (kg) from Baseline to Weeks 36 and 48(Baseline to Weeks 36 and 48)
- Percent Change in Body Weight from Baseline to Weeks 16, 28, 36, and 48 by Obesity Class(Baseline to Weeks 16, 28, 36, and 48)
- Change in HbA1c from Baseline to Weeks 16 and 28(Baseline to Weeks 16 and 28)
- Change in HbA1c from Baseline to Weeks 16, 28, 36, and 48 by Obesity Class(Baseline to Weeks 16, 28, 36, and 48)
- Percentage of Participants with HbA1c ≤6.5% at Weeks 16, 28, 36, and 48(Weeks 16, 28, 36, and 48)
- Percentage of Participants with HbA1c <5.7% at Weeks 16, 28, 36, and 48(Weeks 16, 28, 36, and 48)
- Change in 7-point Self-Monitored Blood Glucose (SMBG) Profile at Weeks 16, 28, 36, and 48(Weeks 16, 28, 36, and 48)
- Percentage of Participants who Achieve HbA1c ≤6.5% and ≥10.0% Weight Reduction at Weeks 16, 28, 36, and 48(Baseline, Weeks 16, 28, 36, and 48)
- Percentage of Participants who Achieve HbA1c <7.0% and ≥5.0% Weight Reduction at Weeks 16, 28, 36, and 48(Baseline, Weeks 16, 28, 36, and 48)
- Change in Body Mass Index (BMI) from Baseline to Weeks 36 and 48(Baseline, Weeks 36 and 48)
- Change in Waist Circumference from Baseline to Weeks 36 and 48(Baseline, Weeks 36 and 48)
- Change in Hip Circumference from Baseline to Weeks 36 and 48(Baseline, Weeks 36 and 48)
- Change in Waist-to-Hip Ratio from Baseline to Weeks 36 and 48(Baseline, Weeks 36 and 48)
- Change in Waist-to-Height Ratio from Baseline to Weeks 36 and 48(Baseline, Weeks 36 and 48)
- Change in Fasting Plasma Glucose from Baseline to Weeks 16, 28, 36, and 48(Baseline to Weeks 16, 28, 36, and 48)
- Change in Fasting Insulin from Baseline to Weeks 16, 28, 36, and 48(Baseline to Weeks 16, 28, 36, and 48)
- Change in Fasting C-peptide from Baseline to Weeks 16, 28, 36, and 48(Baseline to Weeks 16, 28, 36, and 48)
- Change in Fasting Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) from Baseline to Weeks 16, 28, 36, and 48(Baseline to Weeks 16, 28, 36, and 48)
研究者
研究点 (70)
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