Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05814107




Registration number
NCT05814107
Ethics application status
Date submitted
23/02/2023
Date registered
14/04/2023
Date last updated
15/06/2023

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: CT-996 - Capsule of CT-996 intervention

Placebo Comparator: Placebo - Capsule of placebo matching CT-996 dose


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

Treatment: Drugs: Placebo
Capsule of Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Treatment-Emergent Adverse Events in CT-996 participants
Timepoint [1] 0 0
Baseline up to 28 days
Secondary outcome [1] 0 0
Maximum observe drug concentration (Cmax) of CT-996
Timepoint [1] 0 0
Baseline up to 28 days
Secondary outcome [2] 0 0
Effect of a High-Fat Meal on Plasma Concentration of CT-996
Timepoint [2] 0 0
Baseline 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
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 administering 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
1/11/2024
Actual
Sample size
Target
118
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Carmot Clinical Research Unit 101 - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Carmot Australia First Pty Ltd
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Carmot Therapeutics, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
A study designed to assess the safety and tolerability, pharmacokinetics, and
pharmacodynamics of CT-996 in overweight/obese participants and participants with T2DM.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05814107
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael Elliott
Address 0 0
Carmot Therapeutics, Inc.
Country 0 0
Phone 0 0
Fax 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
Fax 0 0
Email 0 0
melliott@carmot.us
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05814107