A Study to Assess CT-868 and the Relationship Between Insulin Secretory Response and Ambient Blood Glucose
A Randomized, Double-Blind, Placebo and Comparator-Controlled Crossover Study to Assess Pharmacokinetic and Pharmacodynamic Effects of CT-868 on the Relationship Between Insulin Secretory Response and Ambient Blood Glucose in Obese Male Subjects and Subjects with T2DM
1 other identifier
interventional
32
1 country
1
Brief Summary
A Study to Assess the Effect of CT-868 and the Relationship Between Insulin Secretory Response and Ambient Blood Glucose in Obese Male Subjects and Subjects with T2DM.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 diabetes
Started Jul 2021
Typical duration for phase_1 diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 14, 2021
CompletedStudy Start
First participant enrolled
July 16, 2021
CompletedFirst Posted
Study publicly available on registry
July 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 22, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 22, 2022
CompletedMarch 28, 2025
March 1, 2025
9 months
July 14, 2021
March 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in insulin secretion rate and ambient glucose levels
Baseline up to 4 days
Secondary Outcomes (2)
Change in blood insulin levels at each level of glucose infusion
Baseline up to 4 days
Change in blood glucose levels at each level of glucose infusion
Baseline up to 4 days
Study Arms (3)
CT-868
EXPERIMENTALSC dose of CT-868 Intervention: Drug: CT-868
Placebo
PLACEBO COMPARATORSC dose of placebo matching CT-868 dose Intervention: Drug: Placebo
Active Comparator
ACTIVE COMPARATORSC dose of Active Comparator Intervention: Drug: Active Comparator
Interventions
Eligibility Criteria
You may qualify if:
- Part 1: Obese Otherwise Healthy Males
- Part 2: Males or Females with T2D
- Part 1: BMI 30.0-35.0, inclusive
- Part 2: BMI 27.0-45.0, inclusive
- years old, inclusive
- Stable body weight for 2 months
You may not qualify if:
- Significant medical history
- Uncontrolled hypertension
- History of malignancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Carmot Clinical Research Unit 101
Chula Vista, California, 91911, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Carmot Therapeutics, Inc., a member of the Roche Group
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2021
First Posted
July 22, 2021
Study Start
July 16, 2021
Primary Completion
April 22, 2022
Study Completion
April 22, 2022
Last Updated
March 28, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share