Home › Trials › NCT06628362

Evaluating CT-388 for overweight or obese individuals with Type 2 diabetes

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of Once-Weekly CT-388 Administered Subcutaneously for 48 Weeks to Participants Who Are Overweight or Obese With Type 2 Diabetes Mellitus

PHASE2 · Carmot Therapeutics, Inc. · NCT06628362

This study is testing a new medication called CT-388 to see if it can help overweight or obese people with Type 2 diabetes manage their condition better.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment360 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorCarmot Therapeutics, Inc. (industry)
Locations43 sites (Anniston, Alabama and 42 other locations)
Trial IDNCT06628362 on ClinicalTrials.gov

What this trial studies

This multi-center, randomized, double-blind, placebo-controlled study aims to assess the efficacy and safety of CT-388 in participants who are overweight or obese and have Type 2 diabetes mellitus (T2DM). Participants will receive either CT-388 at varying doses or a placebo, allowing researchers to determine the optimal dosage for effectiveness. The study will include individuals aged 18 to 75 with a BMI of 25 or higher and specific HbA1c levels. The goal is to find a treatment that can help manage T2DM in this population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with a BMI of 25 or higher and a diagnosis of Type 2 diabetes mellitus.

Not a fit: Patients with Type 1 diabetes or those who have had severe hypoglycemic episodes may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new option for managing Type 2 diabetes in overweight or obese patients.

How similar studies have performed: Other studies have explored treatments for Type 2 diabetes in similar populations, but the specific approach with CT-388 is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Male or female, 18 to 75 years of age
* Body mass index (BMI) ≥25.0 kg/m\^2
* Have a diagnosis of Type 2 Diabetes Mellitus (T2DM) according to the World Health Organization classification or other locally applicable standards
* Have an HbA1c ≥7% and ≤10.5%
* Management of T2DM with diet and exercise alone or diet and exercise and treatment with metformin or a sodium-glucose cotransporter-2 (SGLT-2) inhibitor as monotherapy or in combination, per approved local label
* At least one self-reported unsuccessful diet/exercise effort to lose body weight

Exclusion Criteria:

* Have Type 1 Diabetes Mellitus (T1DM), history of ketosis or hyperosmolar state/coma, or any other types of diabetes except T2DM
* Have had 1 or more episodes of Level 3 hypoglycemia or have had hypoglycemia unawareness within 3 months prior to screening
* Have history or presence of proliferative diabetic retinopathy, diabetic macular edema, non-proliferative diabetic retinopathy that requires acute treatment
* Have presence of active neuropathy (including resting tachycardia, orthostatic hypotension, or diabetic diarrhea)
* Had treatment with any oral antihyperglycemic medications, with the exception of metformin or SGLT-2 inhibitors, within 3 months prior to screening or planned concurrent treatment with these medications during the study
* Had treatment with injectable antihyperglycemic medication, with the exception of short-term insulin, within 6 months prior to screening or planned concurrent treatment with these medications during the study
* Self-reported body weight change of \>5 kg within 3 months before screening
* Any unbalanced/extreme diets, such as very low calorie, low carbohydrate, very high protein, ketogenic, or intermittent diets, within 3 months of the screening visit, or plan to be on such diets during the study
* Current or recent participation in an organized weight reduction program
* Current or recent use of any treatment that promotes weight loss or glucose metabolism
* Current or recent use of treatment that may cause weight gain
* Prior or planned surgical treatment for obesity
* Clinically significant or active gastric emptying abnormality, malabsorption, or chronic use of medications that directly affect GI motility
* History of chronic pancreatitis or acute pancreatitis within 6 months before screening
* Have obesity induced by other endocrinologic disorders (e.g., Cushing syndrome) or diagnosed monogenetic or syndromic forms of obesity
* History of major depressive disorder within 2 years of screening
* Family or personal history of medullary thyroid carcinoma
* Women who are pregnant, breastfeeding, or intend to become pregnant, or are of childbearing potential and not using a highly effective contraceptive method

Where this trial is running

Anniston, Alabama and 42 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Overweight or Obese, Type 2 Diabetes Mellitus

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.