NCT05814107

Brief Summary

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P75+ for phase_1 type-2-diabetes

Timeline
Completed

Started May 2023

Longer than P75 for phase_1 type-2-diabetes

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 14, 2023

Completed
25 days until next milestone

Study Start

First participant enrolled

May 9, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 7, 2025

Completed
Last Updated

November 28, 2025

Status Verified

November 1, 2025

Enrollment Period

2.5 years

First QC Date

February 23, 2023

Last Update Submit

November 26, 2025

Conditions

Type 2 DiabetesOverweight or Obesity

Keywords

Type 2 DiabetesObesityOverweight

Outcome Measures

Primary Outcomes (1)

  • Incidence of Treatment-Emergent Adverse Events

    From first study drug administration until last safety follow-up (up to 31 days [Part 1] or 58 days [Parts 2 and 3])

Secondary Outcomes (12)

  • Maximum Observed Plasma Concentration (Cmax) of CT-996

    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

    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

    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

    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

    At prespecified timepoints from Day 1 to Day 5 (Part 1) or Day 33 (Parts 2 and 3)

  • +7 more secondary outcomes

Study Arms (13)

Part 1: CT-996 SAD Cohort 1

EXPERIMENTAL
Drug: CT-996

Part 1: CT-996 SAD Cohort 2

EXPERIMENTAL
Drug: CT-996

Part 1: CT-996 SAD Cohort 3, Then SAD Cohort 5

EXPERIMENTAL

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

Part 1: CT-996 SAD Cohort 4

EXPERIMENTAL
Drug: CT-996

Part 1: CT-996 SAD Cohort 6

EXPERIMENTAL
Drug: CT-996

Part 1: Placebo SAD Cohort

PLACEBO COMPARATOR
Drug: Placebo

Part 2: CT-996 MAD Cohort 1

EXPERIMENTAL
Drug: CT-996

Part 2: CT-996 MAD Cohort 2

EXPERIMENTAL
Drug: CT-996

Part 2: CT-996 MAD Cohort 3

EXPERIMENTAL
Drug: CT-996

Part 2: Placebo MAD Cohort

PLACEBO COMPARATOR
Drug: Placebo

Part 3: CT-996 MD T2DM Cohort 1

EXPERIMENTAL
Drug: CT-996

Part 3: CT-996 MD T2DM Cohort 2

EXPERIMENTAL
Drug: CT-996

Part 3: Placebo MD T2DM Cohort

PLACEBO COMPARATOR
Drug: Placebo

Interventions

CT-996DRUG

Capsule of CT-996

Also known as: RO7795081, RG6652
Part 1: CT-996 SAD Cohort 1Part 1: CT-996 SAD Cohort 2Part 1: CT-996 SAD Cohort 3, Then SAD Cohort 5Part 1: CT-996 SAD Cohort 4Part 1: CT-996 SAD Cohort 6Part 2: CT-996 MAD Cohort 1Part 2: CT-996 MAD Cohort 2Part 2: CT-996 MAD Cohort 3Part 3: CT-996 MD T2DM Cohort 1Part 3: CT-996 MD T2DM Cohort 2
PlaceboDRUG

Capsule of placebo matching CT-996.

Part 1: Placebo SAD CohortPart 2: Placebo MAD CohortPart 3: Placebo MD T2DM Cohort

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Nucleus Network Pty Ltd.

Melbourne, 3004, Australia

Location

Avant Santé Research Center S.A. de C.V.

San Pedro Garza García, 66260, Mexico

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2OverweightObesity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Clinical Trials

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2023

First Posted

April 14, 2023

Study Start

May 9, 2023

Primary Completion

November 7, 2025

Study Completion

November 7, 2025

Last Updated

November 28, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)ME(1)