A Study of CT-388 in Otherwise Healthy Overweight and Obe... | NCT04838405

Studies
A Study of CT-388 in Otherwise Healthy Overweight and Obese Adults and Patients With Type 2 Diabetes Mellitus

NCT04838405

Sponsor

Carmot Therapeutics, Inc.

Status

Completed

Last Update Posted

Oct 20, 2025Actual

Enrollment

129Actual

Phase

Phase 1

Conditions

Diabetes

Interventions

CT-388
Placebo

Countries

Australia
Mexico

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 29, 2021Actual

Primary Completion Date

Jun 18, 2024Actual

Completion Date

Aug 2, 2024Actual

First Submitted Date

Apr 5, 2021

First Submission Date that Met QC Criteria

Apr 6, 2021

First Posted Date

Apr 9, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 15, 2025

Last Update Posted Date

Oct 20, 2025Actual

Name	Class
Carmot Australia First Pty Ltd	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

129Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CT-388	Experimental	SC dose of CT-388	Drug: CT-388
Placebo	Placebo Comparator	SC dose of placebo matching CT-388 dose	Drug: Placebo
CT-388 Optional	Experimental	SC dose of CT-388	Drug: CT-388
CT-388 MD	Experimental	SC dose of CT-388	Drug: CT-388

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CT-388	Drug	Synthetic Peptide	CT-388 CT-388 MD CT-388 Optional

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of Treatment-Emergent Adverse Events as assessed by self-report	Safety and tolerability	Baseline up to 24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Area under the concentration versus time curve (AUC)	PK AUC	Baseline up to 24 weeks
Maximum observed drug concentration (Cmax)	PK Cmax

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males or females
18-65 years old, inclusive
BMI 27.0-40.0, inclusive
Stable body weight for 2 months

Exclusion Criteria:

Significant medical history
Uncontrolled hypertension
History of malignancy

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clinical Trials	Carmot Therapeutics, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Carmot Clinical Research Unit 101		Perth	Western Australia	6009	Australia
Carmot Clinical Research Unit 105

Label	URL
Carmot Therapeutics, Inc.	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided