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New weekly shot shows promise for weight loss and diabetes

NCT ID NCT06628362

Disease control Sponsor: Carmot Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new weekly injection called enicepatide (CT-388) in 447 overweight or obese adults with type 2 diabetes. Participants receive either the drug or a placebo for 48 weeks. The goal is to see if the drug helps with weight loss and improves blood sugar levels.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Enicepatide (CT-388)
What this could lead to
If successful, this could lead to a new once-weekly injection that helps people with type 2 diabetes lose weight and better control their blood sugar.
What could go wrong
This is an early-phase trial with only 447 participants, so results may not apply to everyone. Side effects and lack of long-term data are common risks at this stage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

447 people

The number who actually took part.

Started

Nov 2024

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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, 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, or non-proliferative diabetic retinopathy that requires acute treatment * Have evidence of clinically significant autonomic neuropathy (symptoms may include 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 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 or procedure for obesity, except for liposuction or abdominoplasty if performed \>1 year prior to screening. Participants with a history of devices, such as LAP-BAND® or intragastric balloon, are permitted, if devices were removed \>1 year prior to screening. * History of clinically significant or active gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction, intestinal obstruction), or chronic use of medications that directly affect GI motility * History of chronic pancreatitis or acute pancreatitis or have signs and symptoms of acute pancreatitis at screening * Have obesity induced by other endocrinologic disorders (e.g., Cushing syndrome) or diagnosed monogenetic or syndromic forms of obesity * History or diagnosis of significant active or unstable major depressive disorder or any history/diagnosis of other severe psychiatric conditions (e.g., schizophrenia; bipolar disorder; other serious mood disorder or anxiety disorder, or hyperactivity disorder) within the last year before screening * History of any hematologic conditions that may interfere with HbA1c measurement (e.g., hemolytic anemias, sickle cell disease, other hemoglobinopathies) * 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 as required per protocol

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Conditions

The condition(s) this trial relates to.

Obesity Overweight type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Overweight or obese Type 2 diabetes mellitus (T2DM)

Contacts and locations

Locations

  • AMCR Institute

    Escondido, California, 92025, United States

  • Accellacare - Hickory

    Hickory, North Carolina, 28601, United States

  • Accellacare Research of Winston Salem

    Winston-Salem, North Carolina, 27103, United States

  • Accellacare of Cary

    Cary, North Carolina, 27518, United States

  • Accellacare of Piedmont Healthcare

    Statesville, North Carolina, 28625, United States

  • Accellacare of Rocky Mount

    Rocky Mount, North Carolina, 27804, United States

  • Accellacare of Wilmington, LLC

    Wilmington, North Carolina, 28401, United States

  • Aggarwal and Associates

    Brampton, Ontario, L6T 0G1, Canada

  • Aging Well Associates

    St. Petersburg, Florida, 33713, United States

  • Ark Clinical Research

    Long Beach, California, 90806, United States

  • Ark Clinical-Fountain Valley

    Fountain Valley, California, 92708, United States

  • Asclepes Research Centers

    Sherman Oaks, California, 91403, United States

  • Avant Santé Research Center

    San Pedro Garza García, 66260, Mexico

  • CEMDEC S.A. de C.V.

    Cuauhtémoc, 06100, Mexico

  • Catalina Research Institute, LLC

    Montclair, California, 91763, United States

  • Centennial Medical Group

    Elkridge, Maryland, 21075, United States

  • Central Alabama Research

    Birmingham, Alabama, 35209-8401, United States

  • Centricity Research Brampton Endocrinology

    Brampton, Ontario, L6S 0C6, Canada

  • Centro De Investigacion En Artritis Y Osteopososis

    Mexicali, 21200, Mexico

  • Centro Medico Viamonte SRL

    Buenos Aires, Provincia de Buenos, 1120, Argentina

  • Clinicos Asociados Bocm, S.C.

    Mexico City, 03300, Mexico

  • Consano Clinical Research

    Shavano Park, Texas, 78231, United States

  • Cotton O'Neil Clinical Research Center

    Topeka, Kansas, 66606, United States

  • Diabetes and Endocrinology Associates of Stark County, Inc.

    Canton, Ohio, 44718, United States

  • Duly Health and Care

    Lombard, Illinois, 60148, United States

  • Ellipsis Research Group

    Brooklyn, New York, 11215, United States

  • Encompass Clinical Research

    Spring Valley, California, 91978, United States

  • FAICIC S de R.L. de C.V

    Veracruz, 91900, Mexico

  • Flourish Research - Boca Raton

    Boca Raton, Florida, 33434, United States

  • Flourish Research Acquisition, LLC

    Miami, Florida, 33138, United States

  • Flourish Research Acquisition, LLC dba Flourish Bowie

    Bowie, Maryland, 20715, United States

  • FutureSearch Trials of Neurology

    Austin, Texas, 78731, United States

  • ISIS Clinical Research Center

    Guaynabo, 00970, Puerto Rico

  • Instituto de Diabetes Obesidad y Nutricion, SC

    Cuernavaca, 62250, Mexico

  • Juno Research, LLC

    Houston, Texas, 77040, United States

  • K2 Medical Research Tampa

    Tampa, Florida, 33607, United States

  • K2 Medical Research, LLC - Maitland

    Maitland, Florida, 32751, United States

  • K2 Medical Research, LLC - Orlando

    Maitland, Florida, 32751, United States

  • K2 Medical Research, LLC - South Orlando

    Orlando, Florida, 32806, United States

  • K2 Summit Research

    The Villages, Florida, 32159, United States

  • Lakeview Clinical Research, LLC

    Guntersville, Alabama, 35976, United States

  • Manassas Clinical Research Center

    Manassas, Virginia, 20110, United States

  • McFarland Clinic

    Ames, Iowa, 50010, United States

  • Medical Care and Research S.A de C.V

    Mérida, 97070, Mexico

  • Momentum Pukekohe

    Auckland, 2120, New Zealand

  • Momentum Wellington

    Wellington, 6021, New Zealand

  • NECCR PrimaCare Research LLC

    Fall River, Massachusetts, 02721, United States

  • NOLA Cares, LLC

    Metairie, Louisiana, 70006, United States

  • Norwood Family Medicine

    Knoxville, Tennessee, 37912, United States

  • Olive Branch Family Medical Center; Family Medicine

    Olive Branch, Mississippi, 38654, United States

  • Optimal Clinical Trials

    Grafton, 1010, New Zealand

  • Optimal Clinical Trials - North

    Rosedale, Auckland, 0632, New Zealand

  • Orange Country Research Center

    Lake Forest, California, 92630, United States

  • Privia Medical Group Georgia - Thomasville

    Thomasville, Georgia, 31792, United States

  • Privia Medical Group Georgia, LLC

    Fayetteville, Georgia, 30214, United States

  • Privia Medical Group North Texas - Stephenville

    Stephenville, Texas, 76401, United States

  • Roper St. Francis Physician Partners - Primary Care

    Mt. Pleasant, South Carolina, 29464, United States

  • Rophe Adult and Pediatric Medicine/SKYCRNG

    Union City, Georgia, 30291, United States

  • SINACOR

    Culiacán, 80230, Mexico

  • SKY Integrative Medical Center/SKYCRNG

    Ridgeland, Mississippi, 39157, United States

  • Sociedad de Metabolismo y Corazon S.C.

    Veracruz, 91855, Mexico

  • Summit-Halls Family Practice

    Knoxville, Tennessee, 37938, United States

  • Tampa Bay Medical Research

    Clearwater, Florida, 33761, United States

  • Tauranga Hospital

    Tauranga, 3110, New Zealand

  • Tekton Research

    Edmond, Oklahoma, 73013, United States

  • University of Alabama at Birmingham (UAB)

    Birmingham, Alabama, 35233, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198, United States

  • University of Texas Southwestern Medical Center Investigation Drug Services

    Dallas, Texas, 75390, United States

  • Velocity Clinical Research - Dallas

    Dallas, Texas, 75230, United States

  • Yuma Clinical Trials

    Yuma, Arizona, 85364, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.