Phase 1 Study of CT-996 in Overweight/Obese Participants and Patients With Type 2 Diabetes Mellitus

November 26, 2025 updated by: Carmot Australia First Pty Ltd

A Double-Blind, Randomized, Placebo-Controlled Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of CT-996 in Overweight/Obese Participants and in Patients With Type 2 Diabetes Mellitus

This study is designed to assess the safety and tolerability, pharmacokinetics, and pharmacodynamics of CT-996 in overweight/obese participants and participants with Type 2 Diabetes Mellitus (T2DM).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a multi-center, randomized, double-blind, placebo-controlled, dose escalation, first in human study designed to assess the safety and tolerability, pharmacokinetics, and pharmacodynamics of CT-996 when administered as single ascending doses (SAD) and multiple-ascending doses (MAD) in overweight/obese participants and as multiple doses (MD) in patients with T2DM.

Study Type

Interventional

Enrollment (Actual)

94

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Melbourne, Australia, 3004
        • Nucleus Network Pty Ltd.
  • Mexico
      • San Pedro Garza García, Mexico, 66260
        • Avant Santé Research Center S.A. de C.V.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Participants 18-65 years old, inclusive
  • BMI of 25 - 40, inclusive
  • Stable body weight for two months

Additional Inclusion Criterion for Part 3 (MD T2DM cohorts) only:

  • Participants in Part 3 should have a documented diagnosis of Type 2 Diabetes Mellitus (T2DM)
  • Participants in Part 3 should have glycated hemoglobin (HbA1c) between 7.0% and 10.0%

Exclusion Criteria:

  • History of significant medical conditions and malignancy
  • Uncontrollable hypertension
  • History of alcoholism or drug addiction within 1 year prior to Screening
  • Current or recent participation in an investigational clinical trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1: CT-996 SAD Cohort 1
Drug: CT-996
Capsule of CT-996
Other Names:
  • RG6652
  • RO7795081
Experimental: Part 1: CT-996 SAD Cohort 2
Drug: CT-996
Capsule of CT-996
Other Names:
  • RG6652
  • RO7795081
Experimental: Part 1: CT-996 SAD Cohort 3, Then SAD Cohort 5
During SAD Cohort 3, participants will be dosed under fasted conditions. During SAD Cohort 5, the same participants will receive the same dose under high-fat fed conditions.
Drug: CT-996
Capsule of CT-996
Other Names:
  • RG6652
  • RO7795081
Experimental: Part 1: CT-996 SAD Cohort 4
Drug: CT-996
Capsule of CT-996
Other Names:
  • RG6652
  • RO7795081
Experimental: Part 1: CT-996 SAD Cohort 6
Drug: CT-996
Capsule of CT-996
Other Names:
  • RG6652
  • RO7795081
Placebo Comparator: Part 1: Placebo SAD Cohort
Drug: Placebo
Capsule of placebo matching CT-996.
Experimental: Part 2: CT-996 MAD Cohort 1
Drug: CT-996
Capsule of CT-996
Other Names:
  • RG6652
  • RO7795081
Experimental: Part 2: CT-996 MAD Cohort 2
Drug: CT-996
Capsule of CT-996
Other Names:
  • RG6652
  • RO7795081
Experimental: Part 2: CT-996 MAD Cohort 3
Drug: CT-996
Capsule of CT-996
Other Names:
  • RG6652
  • RO7795081
Placebo Comparator: Part 2: Placebo MAD Cohort
Drug: Placebo
Capsule of placebo matching CT-996.
Experimental: Part 3: CT-996 MD T2DM Cohort 1
Drug: CT-996
Capsule of CT-996
Other Names:
  • RG6652
  • RO7795081
Experimental: Part 3: CT-996 MD T2DM Cohort 2
Drug: CT-996
Capsule of CT-996
Other Names:
  • RG6652
  • RO7795081
Placebo Comparator: Part 3: Placebo MD T2DM Cohort
Drug: Placebo
Capsule of placebo matching CT-996.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of Treatment-Emergent Adverse Events
Time Frame: From first study drug administration until last safety follow-up (up to 31 days [Part 1] or 58 days [Parts 2 and 3])
From first study drug administration until last safety follow-up (up to 31 days [Part 1] or 58 days [Parts 2 and 3])

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Observed Plasma Concentration (Cmax) of CT-996
Time Frame: At prespecified timepoints from Day 1 to Day 5 (Part 1) or Day 33 (Parts 2 and 3)
At prespecified timepoints from Day 1 to Day 5 (Part 1) or Day 33 (Parts 2 and 3)
Time to Maximum Observed Plasma Concentration (Tmax) of CT-996
Time Frame: At prespecified timepoints from Day 1 to Day 5 (Part 1) or Day 33 (Parts 2 and 3)
At prespecified timepoints from Day 1 to Day 5 (Part 1) or Day 33 (Parts 2 and 3)
Area Under the Concentration-Time Curve (AUC) from Time 0 to the Time of Last Measurable Concentration (AUC0-t) of CT-996
Time Frame: At prespecified timepoints from Day 1 to Day 5 (Part 1) or Day 33 (Parts 2 and 3)
At prespecified timepoints from Day 1 to Day 5 (Part 1) or Day 33 (Parts 2 and 3)
AUC from Time 0 Extrapolated to Infinity (AUC0-inf) of CT-996
Time Frame: At prespecified timepoints from Day 1 to Day 5 (Part 1) or Day 33 (Parts 2 and 3)
At prespecified timepoints from Day 1 to Day 5 (Part 1) or Day 33 (Parts 2 and 3)
Apparent Terminal Elimination Half-Life (t1/2) of CT-996
Time Frame: At prespecified timepoints from Day 1 to Day 5 (Part 1) or Day 33 (Parts 2 and 3)
At prespecified timepoints from Day 1 to Day 5 (Part 1) or Day 33 (Parts 2 and 3)
Part 1 Cohorts: Clearance (CL) of CT-996
Time Frame: At prespecified timepoints from Day 1 to Day 5
At prespecified timepoints from Day 1 to Day 5
Part 1 Cohorts: Volume of Distribution (V) of CT-996
Time Frame: At prespecified timepoints from Day 1 to Day 5
At prespecified timepoints from Day 1 to Day 5
Part 2 Cohorts: Minimum Observed Plasma Concentration (Cmin) of CT-996
Time Frame: At prespecified timepoints from Day 1 to Day 33
At prespecified timepoints from Day 1 to Day 33
Parts 2 and 3 Cohorts: Clearance Divided by the Bioavailable Fraction (CL/F) of CT-996
Time Frame: At prespecified timepoints from Day 1 to Day 33
At prespecified timepoints from Day 1 to Day 33
Parts 2 and 3 Cohorts: Volume of Distribution Divided by the Bioavailable Fraction (Vz/F) of CT-996
Time Frame: At prespecified timepoints from Day 1 to Day 33
At prespecified timepoints from Day 1 to Day 33
Part 1 SAD Cohorts 3 and 5: Food Effect of a High-Fat Meal on Cmax of CT-996
Time Frame: At prespecified timepoints for up to 14 days
Determine the effect of a high-fat meal on the PK of CT-996 following a single dose
At prespecified timepoints for up to 14 days
Part 1 SAD Cohorts 3 and 5: Food Effect of a High-Fat Meal on AUC of CT-996
Time Frame: At prespecified timepoints for up to 14 days
Determine the effect of a high-fat meal on the PK of CT-996 following a single dose
At prespecified timepoints for up to 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carmot Australia First Pty Ltd

Collaborators

Hoffmann-La Roche
Carmot Therapeutics, Inc.

Investigators

  • Study Director: Clinical Trials, Carmot Therapeutics, Inc., a Member of the Roche Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 9, 2023

Primary Completion (Actual)

November 7, 2025

Study Completion (Actual)

November 7, 2025

Study Registration Dates

First Submitted

February 23, 2023

First Submitted That Met QC Criteria

April 3, 2023

First Posted (Actual)

April 14, 2023

Study Record Updates

Last Update Posted (Actual)

November 28, 2025

Last Update Submitted That Met QC Criteria

November 26, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT-996-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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