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

Carmot Therapeutics, Inc.70 个研究点分布在 1 个国家目标入组 360 人2024年11月21日

适应症Overweight or Obese Type 2 Diabetes Mellitus (T2DM)

干预措施Placebo Enicepatide

概览

阶段: 2 期
干预措施: Placebo
疾病 / 适应症: Overweight or Obese
发起方: Carmot Therapeutics, Inc.
入组人数: 360
试验地点: 70
主要终点: Percent Change in Body Weight from Baseline to Week 36
状态: 进行中（未招募）
最后更新: 15天前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

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).

注册库

clinicaltrials.gov

开始日期

2024年11月21日

结束日期

2026年9月24日

最后更新

15天前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Carmot Therapeutics, Inc.

责任方

Sponsor

入排标准

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

研究组 & 干预措施

Arm 1: Placebo

干预措施: Placebo

Arm 3: Enicepatide Dose Level 2

干预措施: Enicepatide

Arm 4: Enicepatide Dose Level 3

干预措施: Enicepatide

Arm 5: Enicepatide Dose Level 4 (High)

干预措施: Enicepatide

Arm 2: Enicepatide Dose Level 1 (Low)

干预措施: Enicepatide

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)