NCT04838405

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 Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P75+ for phase_1 diabetes

Timeline
Completed

Started Apr 2021

Longer than P75 for phase_1 diabetes

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 9, 2021

Completed
20 days until next milestone

Study Start

First participant enrolled

April 29, 2021

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2024

Completed
Last Updated

October 20, 2025

Status Verified

October 1, 2025

Enrollment Period

3.1 years

First QC Date

April 5, 2021

Last Update Submit

October 15, 2025

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

  • Incidence of Treatment-Emergent Adverse Events as assessed by self-report

    Safety and tolerability

    Baseline up to 24 weeks

Secondary Outcomes (6)

  • Area under the concentration versus time curve (AUC)

    Baseline up to 24 weeks

  • Maximum observed drug concentration (Cmax)

    Baseline up to 24 weeks

  • Elimination half-life

    Baseline up to 24 weeks

  • Change in mean body weight

    Baseline up to 24 weeks

  • Change in mean glucose levels

    Baseline up to 24 weeks

  • +1 more secondary outcomes

Study Arms (4)

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

CT-388DRUG

Synthetic Peptide

CT-388CT-388 MDCT-388 Optional
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Significant medical history
  • Uncontrolled hypertension
  • History of malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Carmot Clinical Research Unit 101

Perth, Western Australia, 6009, Australia

Location

Carmot Clinical Research Unit 105

Monterrey, Nuevo León, 66260, Mexico

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Clinical Trials

    Carmot Therapeutics, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2021

First Posted

April 9, 2021

Study Start

April 29, 2021

Primary Completion

June 18, 2024

Study Completion

August 2, 2024

Last Updated

October 20, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)ME(1)