NCT05110846CompletedPhase 2
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multiple-Center Study to Evaluate the Efficacy, Safety, and Tolerability of CT-868 Administered for 26 Weeks to Overweight and Obese Participants With Type 2 Diabetes Mellitus
Carmot Therapeutics, Inc.5 sites in 1 country103 target enrollmentStarted: February 22, 2022Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Carmot Therapeutics, Inc.
- Enrollment
- 103
- Locations
- 5
- Primary Endpoint
- Change from Baseline in Glycated Hemoglobin A1c (HbA1c) at Week 26
Study Overview
Brief Summary
A study to assess the effect of CT-868 in lowering glycated hemoglobin A1c (HbA1c) in overweight and obese participants with inadequately controlled Type 2 diabetes mellitus (T2DM).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Males or Females with T2DM
- •BMI of ≥27 kg/m2, inclusive
- •18-75 years old, inclusive
- •Stable body weight for 3 months
Exclusion Criteria
- •Significant medical history
- •Uncontrolled diabetes
- •History of malignancy
Arms & Interventions
CT-868 1.75 mg
Experimental
Participants in the CT-868 1.75 mg arm received 1.0 mg/day for 2 weeks followed by 1.75 mg/day for the remaining treatment period.
Intervention: CT-868 (Drug)
CT-868 4.0 mg
Experimental
Participants in the CT-868 4.0 mg arm escalated through 1.0 mg/day for 2 weeks, 1.75 mg/day for 2 weeks, 2.5 mg/day for 4 weeks, 3.25 mg/day for 4 weeks, to 4.0 mg/day for the remaining 14 weeks.
Intervention: CT-868 (Drug)
Placebo
Placebo Comparator
Participants in the placebo arm received volume- and regimen-matched placebo.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change from Baseline in Glycated Hemoglobin A1c (HbA1c) at Week 26
Time Frame: Baseline and Week 26
Secondary Outcomes
- Change from Baseline in HbA1c at Week 12(Baseline and Week 12)
- Percentage of Participants Achieving HbA1c <5.7% at Weeks 12 and 26(Baseline and Weeks 12 and 26)
- Percentage of Participants Achieving HbA1c ≤6.5% at Weeks 12 and 26(Baseline and Weeks 12 and 26)
- Percentage of Participants Achieving HbA1c <7.0% at Weeks 12 and 26(Baseline and Weeks 12 and 26)
- Percent Change from Baseline in Body Weight at Weeks 12 and 26(Baseline and Weeks 12 and 26)
- Absolute (kg) Change from Baseline in Body Weight at Weeks 12 and 26(Baseline and Weeks 12 and 26)
- Percentage of Participants with ≥5% Body Weight Loss from Baseline at Weeks 12 and 26(Baseline and Weeks 12 and 26)
- Percentage of Participants with ≥10% Body Weight Loss from Baseline at Weeks 12 and 26(Baseline and Weeks 12 and 26)
- Percentage of Participants with ≥15% Body Weight Loss from Baseline at Weeks 12 and 26(Baseline and Weeks 12 and 26)
- Percentage of Participants with ≥20% Body Weight Loss from Baseline at Weeks 12 and 26(Baseline and Weeks 12 and 26)
- Change from Baseline in Fasting Plasma Glucose at Weeks 12 and 26(Baseline and Weeks 12 and 26)
- Change from Baseline in Fasting Insulin at Weeks 12 and 26(Baseline and Weeks 12 and 26)
- Change from Baseline in Waist Circumference at Weeks 12 and 26(Baseline and Weeks 12 and 26)
- Change from Baseline in Hip Circumference at Weeks 12 and 26(Baseline and Weeks 12 and 26)
- Change from Baseline in Waist-to-Hip Ratio at Weeks 12 and 26(Baseline and Weeks 12 and 26)
- Change from Baseline in Waist-to-Height Ratio at Weeks 12 and 26(Baseline and Weeks 12 and 26)
- Change from Baseline in Body Mass Index (BMI) at Weeks 12 and 26(Baseline and Weeks 12 and 26)
- Change from Baseline in Total Cholesterol at Weeks 12 and 26(Baseline and Weeks 12 and 26)
- Change from Baseline in Triglycerides at Weeks 12 and 26(Baseline and Weeks 12 and 26)
- Change from Baseline in Low Density Lipoprotein (LDL) Cholesterol at Weeks 12 and 26(Baseline and Weeks 12 and 26)
- Change from Baseline in High Density Lipoprotein (HDL) Cholesterol at Weeks 12 and 26(Baseline and Weeks 12 and 26)
- Change from Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Weeks 12 and 26(Baseline and Weeks 12 and 26)
- Change from Baseline in Apolipoprotein B at Weeks 12 and 26(Baseline and Weeks 12 and 26)
- Change from Baseline in Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) at Weeks 12 and 26(Baseline and Weeks 12 and 26)
- Change from Baseline in Quantitative Insulin Sensitivity Check Index (QUICKI) at Weeks 12 and 26(Baseline and Weeks 12 and 26)
- Percentage of Participants with at Least One Treatment-Emergent Adverse Event(From first dose of study drug until 4 weeks after the last dose of study drug (30 weeks))
- Percentage of Participants with at Least One Hypoglycemic Event(From first dose of study drug until 4 weeks after the last dose of study drug (30 weeks))
- Percentage of Participants Testing Positive for Anti-Drug Antibodies to CT-868 at Baseline and Anytime Post-Baseline(Baseline and Post-Baseline (up to 30 weeks))
Investigators
Study Sites (5)
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