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CompletedNCT04973111Updated Mar 28, 2025

A Study to Assess CT-868 and the Relationship Between Insulin Secretory Response and Ambient Blood Glucose

A Phase 1 interventional study of CT-868 as SC Injection and Placebo as SC Injection in Diabetes, sponsored by Carmot Therapeutics, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-28.

Sponsored by Carmot Therapeutics, Inc. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Apr 2022, 4 years 5 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes

Keywords

  • Diabetes Mellitus
  • Diabetes Mellitus, Type 2
  • Overweight
  • Metabolic Diseases
  • Body Weight
03

In context

Lead sponsor

Carmot Therapeutics, Inc. is the lead sponsor of 7 studies on the registry; none are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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
  • 18-65 years old, inclusive
  • Stable body weight for 2 months

Exclusion criteria

Exclusion Criteria:

  • Significant medical history
  • Uncontrolled hypertension
  • History of malignancy
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    CT-868

    SC dose of CT-868 Intervention: Drug: CT-868

    Drug: CT-868 as SC Injection

  • Placebo comparator
    Placebo

    SC dose of placebo matching CT-868 dose Intervention: Drug: Placebo

    Drug: Placebo as SC Injection

  • Active comparator
    Active Comparator

    SC dose of Active Comparator Intervention: Drug: Active Comparator

    Drug: Active Comparator as SC Injection

Interventions

  • DrugCT-868 as SC Injection

    CT-868

  • DrugPlacebo as SC Injection

    Placebo

  • DrugActive Comparator as SC Injection

    Active Comparator

06

What researchers measure

Primary outcomes

  1. Change in insulin secretion rate and ambient glucose levels

    Time frame: Baseline up to 4 days

Secondary outcomes

  1. Change in blood insulin levels at each level of glucose infusion

    Time frame: Baseline up to 4 days

  2. Change in blood glucose levels at each level of glucose infusion

    Time frame: Baseline up to 4 days

07

Study locations

1 site
  • Carmot Clinical Research Unit 101
    Chula Vista, California 91911, United States
08

References and documents

Related links

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04973111
Lead sponsor
Carmot Therapeutics, Inc.
Responsible party
Sponsor
First posted
Jul 22, 2021
Start date
Jul 16, 2021
Primary completion
Apr 22, 2022
Completion
Apr 22, 2022
Last update
Mar 28, 2025

Study contacts

Clinical Trials
study director · Carmot Therapeutics, Inc., a member of the Roche Group

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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