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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

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
Assessment method [1] 0 0
To evaluate the safety and tolerability of CT-996
Timepoint [1] 0 0
Baseline up to 28 days
Secondary outcome [1] 0 0
Maximum observe drug concentration (Cmax) of CT-996
Assessment method [1] 0 0
PK Cmax
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
Assessment method [2] 0 0
Determine the effect of a high-fat meal on the PK of CT-996 following a single dose
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
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Carmot Therapeutics, Inc.
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Michael Elliott
Address 0 0
Carmot Therapeutics, Inc.
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