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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04838405




Registration number
NCT04838405
Ethics application status
Date submitted
5/04/2021
Date registered
9/04/2021

Titles & IDs
Public title
A Study of CT-388 in Otherwise Healthy Overweight and Obese Adults and Patients With Type 2 Diabetes Mellitus
Scientific title
A Phase 1 Randomized, Double Blind, Placebo Controlled, Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CT-388 in Otherwise Healthy Overweight and Obese Adult Participants and in Obese Patients With Type 2 Diabetes Mellitus
Secondary ID [1] 0 0
CT-388-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 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-388
Treatment: Drugs - Placebo

Experimental: CT-388 - SC dose of CT-388

Placebo comparator: Placebo - SC dose of placebo matching CT-388 dose


Treatment: Drugs: CT-388
Synthetic Peptide

Treatment: Drugs: Placebo
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 as assessed by self-report
Timepoint [1] 0 0
Baseline up to 6 weeks
Secondary outcome [1] 0 0
Area under the concentration versus time curve (AUC)
Timepoint [1] 0 0
Baseline up to 6 weeks
Secondary outcome [2] 0 0
Maximum observe drug concentration (Cmax)
Timepoint [2] 0 0
Baseline up to 6 weeks
Secondary outcome [3] 0 0
Elimination half-life
Timepoint [3] 0 0
Baseline up to 6 weeks
Secondary outcome [4] 0 0
Change in mean body weight
Timepoint [4] 0 0
Baseline up to 6 weeks
Secondary outcome [5] 0 0
Change in mean glucose levels
Timepoint [5] 0 0
Baseline up to 6 weeks
Secondary outcome [6] 0 0
Change in mean insulin levels
Timepoint [6] 0 0
Baseline up to 6 weeks

Eligibility
Key inclusion criteria
* Males or females
* 18-65 years old, inclusive
* BMI 27.0-40.0, inclusive
* Stable body weight for 2 months
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Significant medical history
* Uncontrolled hypertension
* History of malignancy

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 assessing the outcomes
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
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2023
Actual
Sample size
Target
96
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,WA
Recruitment hospital [1] 0 0
Carmot Clinical Research Unit 102 - Adelaide
Recruitment hospital [2] 0 0
Carmot Clinical Research Unit 101 - Perth
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
Mexico
State/province [1] 0 0
Nuevo Leon

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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/NCT04838405