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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05814107




Registration number
NCT05814107
Ethics application status
Date submitted
23/02/2023
Date registered
14/04/2023
Date last updated
14/07/2025

Titles & IDs
Public title
Phase 1 Study of CT-996 in Overweight/Obese Participants and Patients With Type 2 Diabetes Mellitus
Scientific title
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
Secondary ID [1] 0 0
CT-996-201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 0 0
Overweight or Obesity 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes
Diet and Nutrition 0 0 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CT-996
Treatment: Drugs - Placebo

Experimental: Part 1: CT-996 SAD Cohort 1 -

Experimental: Part 1: CT-996 SAD Cohort 2 -

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.

Experimental: Part 1: CT-996 SAD Cohort 4 -

Experimental: Part 1: CT-996 SAD Cohort 6 -

Placebo comparator: Part 1: Placebo SAD Cohort -

Experimental: Part 2: CT-996 MAD Cohort 1 -

Experimental: Part 2: CT-996 MAD Cohort 2 -

Experimental: Part 2: CT-996 MAD Cohort 3 -

Placebo comparator: Part 2: Placebo MAD Cohort -

Experimental: Part 3: CT-996 MD T2DM Cohort 1 -

Experimental: Part 3: CT-996 MD T2DM Cohort 2 -

Placebo comparator: Part 3: Placebo MD T2DM Cohort -


Treatment: Drugs: CT-996
Capsule of CT-996

Treatment: Drugs: Placebo
Capsule of placebo matching CT-996.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Treatment-Emergent Adverse Events
Assessment method [1] 0 0
Timepoint [1] 0 0
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 [1] 0 0
Maximum Observed Plasma Concentration (Cmax) of CT-996
Assessment method [1] 0 0
Timepoint [1] 0 0
At prespecified timepoints from Day 1 to Day 5 (Part 1) or Day 33 (Parts 2 and 3)
Secondary outcome [2] 0 0
Time to Maximum Observed Plasma Concentration (Tmax) of CT-996
Assessment method [2] 0 0
Timepoint [2] 0 0
At prespecified timepoints from Day 1 to Day 5 (Part 1) or Day 33 (Parts 2 and 3)
Secondary outcome [3] 0 0
Area Under the Concentration-Time Curve (AUC) from Time 0 to the Time of Last Measurable Concentration (AUC0-t) of CT-996
Assessment method [3] 0 0
Timepoint [3] 0 0
At prespecified timepoints from Day 1 to Day 5 (Part 1) or Day 33 (Parts 2 and 3)
Secondary outcome [4] 0 0
AUC from Time 0 Extrapolated to Infinity (AUC0-inf) of CT-996
Assessment method [4] 0 0
Timepoint [4] 0 0
At prespecified timepoints from Day 1 to Day 5 (Part 1) or Day 33 (Parts 2 and 3)
Secondary outcome [5] 0 0
Apparent Terminal Elimination Half-Life (t1/2) of CT-996
Assessment method [5] 0 0
Timepoint [5] 0 0
At prespecified timepoints from Day 1 to Day 5 (Part 1) or Day 33 (Parts 2 and 3)
Secondary outcome [6] 0 0
Part 1 Cohorts: Clearance (CL) of CT-996
Assessment method [6] 0 0
Timepoint [6] 0 0
At prespecified timepoints from Day 1 to Day 5
Secondary outcome [7] 0 0
Part 1 Cohorts: Volume of Distribution (V) of CT-996
Assessment method [7] 0 0
Timepoint [7] 0 0
At prespecified timepoints from Day 1 to Day 5
Secondary outcome [8] 0 0
Part 2 Cohorts: Minimum Observed Plasma Concentration (Cmin) of CT-996
Assessment method [8] 0 0
Timepoint [8] 0 0
At prespecified timepoints from Day 1 to Day 33
Secondary outcome [9] 0 0
Parts 2 and 3 Cohorts: Clearance Divided by the Bioavailable Fraction (CL/F) of CT-996
Assessment method [9] 0 0
Timepoint [9] 0 0
At prespecified timepoints from Day 1 to Day 33
Secondary outcome [10] 0 0
Parts 2 and 3 Cohorts: Volume of Distribution Divided by the Bioavailable Fraction (Vz/F) of CT-996
Assessment method [10] 0 0
Timepoint [10] 0 0
At prespecified timepoints from Day 1 to Day 33
Secondary outcome [11] 0 0
Part 1 SAD Cohorts 3 and 5: Food Effect of a High-Fat Meal on Cmax of CT-996
Assessment method [11] 0 0
Determine the effect of a high-fat meal on the PK of CT-996 following a single dose
Timepoint [11] 0 0
At prespecified timepoints for up to 14 days
Secondary outcome [12] 0 0
Part 1 SAD Cohorts 3 and 5: Food Effect of a High-Fat Meal on AUC of CT-996
Assessment method [12] 0 0
Determine the effect of a high-fat meal on the PK of CT-996 following a single dose
Timepoint [12] 0 0
At prespecified timepoints for up to 14 days

Eligibility
Key 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%
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/05/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/10/2025
Actual
Sample size
Target
94
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Nucleus Network Pty Ltd. - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Mexico
State/province [1] 0 0
San Pedro Garza García

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Carmot Australia First Pty Ltd
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Carmot Therapeutics, Inc.
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Hoffmann-La Roche
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Carmot Therapeutics, Inc., a Member of the Roche Group
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Michael Elliott
Address 0 0
Country 0 0
Phone 0 0
510-666-6328
Email 0 0
melliott@carmot.us
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05814107