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/NCT04838405




Registration number
NCT04838405
Ethics application status
Date submitted
5/04/2021
Date registered
9/04/2021
Date last updated
26/07/2022

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
Recruiting
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
This is a first-in-human evaluation of CT-388 in a double blind, placebo controlled,
randomized, SAD/MAD/MD, safety, tolerance, PK, and PD study when administered as a SC
injection in otherwise healthy overweight and obese adult participants and obese participants
with T2DM.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04838405
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/NCT04838405