A Study to Assess the Effects of CT-868 Treatment on Gluc... | NCT05794581

Studies
A Study to Assess the Effects of CT-868 Treatment on Glucose Homeostasis in Participants with Type 1 Diabetes

NCT05794581

Sponsor

Carmot Therapeutics, Inc.

Status

Completed

Last Update Posted

Dec 27, 2024Actual

Enrollment

32Actual

Phase

Phase 1

Conditions

Type 1 Diabetes

Interventions

CT-868
Placebo
Victoza

Countries

United States

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

Dec 2024

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

Mar 21, 2023Actual

Primary Completion Date

Mar 6, 2024Actual

Completion Date

Apr 6, 2024Actual

First Submitted Date

Mar 10, 2023

First Submission Date that Met QC Criteria

Mar 30, 2023

First Posted Date

Apr 3, 2023Actual

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

Dec 20, 2024

Last Update Posted Date

Dec 27, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study will be conducted primarily to evaluate the effects of CT-868 on glucose homeostasis in participants with Type 1 Diabetes Mellitus.

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

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CT-868	Experimental	SC injection of CT-868 Intervention	Drug: CT-868
Placebo	Placebo Comparator	SC injection of placebo matching CT-868 dose	Drug: Placebo
Victoza	Active Comparator	SC injection of active comparator	Drug: Victoza

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CT-868	Drug	CT-868	CT-868
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To assess area under the curve (AUC) in glucose metabolism during MMTT		Baseline up to 4 days

Secondary Outcomes

Measure	Description	Time Frame
To assess changes in continuous glucose monitoring (CGM) measures		Baseline up to 4 days
Area under the acetaminophen concentration-time (AUC)		0 - 300 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female or male adults with Type 1 diabetes
Ages 18-65 years
Type 1 DM for at least 3 years
Using an insulin pump or multiple daily injections (MDI) for at least 3 months
BMI 25.0 - 35.0

Exclusion Criteria:

Significant medical history
Uncontrolled diabetes
History of surgical treatment for weight loss
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

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Carmot Clinical Research Unit 101		Chula Vista	California	91911	United States

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
D003922	Diabetes Mellitus, Type 1
D009765	Obesity
D050177	Overweight

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069450	Liraglutide

Ancestor Terms

ID	Term
D052216	Glucagon-Like Peptide 1
D004763	Glucagon-Like Peptides
D052336	Proglucagon
D005768	Gastrointestinal Hormones

Browse Leaves

Not provided

Browse Branches

Not provided