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

NCT ID: NCT04973111

Last Updated: 2025-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-16

Study Completion Date

2022-04-22

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CT-868

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

Group Type EXPERIMENTAL

CT-868 as SC Injection

Intervention Type DRUG

CT-868

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo as SC Injection

Intervention Type DRUG

Placebo

Active Comparator

SC dose of Active Comparator Intervention: Drug: Active Comparator

Group Type ACTIVE_COMPARATOR

Active Comparator as SC Injection

Intervention Type DRUG

Active Comparator

Interventions

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CT-868 as SC Injection

CT-868

Intervention Type DRUG

Placebo as SC Injection

Placebo

Intervention Type DRUG

Active Comparator as SC Injection

Active Comparator

Intervention Type DRUG

Eligibility Criteria

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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

* Significant medical history
* Uncontrolled hypertension
* History of malignancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Carmot Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Carmot Therapeutics, Inc., a member of the Roche Group

Locations

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Carmot Clinical Research Unit 101

Chula Vista, California, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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CT-868-003

Identifier Type: -

Identifier Source: org_study_id

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