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CompletedNCT06628362Updated Oct 6, 2026

A Study of Enicepatide (CT-388) in Participants Who Are Overweight or Obese With Type 2 Diabetes Mellitus

A Phase 2 interventional study of Placebo and Enicepatide in Overweight or Obese and Type 2 Diabetes Mellitus (T2DM), sponsored by Carmot Therapeutics, Inc.. Completed at 70 sites in 6 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-06.

Sponsored by Carmot Therapeutics, Inc. · Phase 2, Interventional, and Treatment

Updated Oct 6, 2026Now CompletedStudy completion movedGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
447
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This is a multi-center, randomized, double-blind, placebo-controlled, parallel group dose-finding study to evaluate the efficacy and safety of enicepatide at low, middle, and high doses in participants who are overweight or obese with Type 2 diabetes mellitus (T2DM).

02

Conditions studied

  • Overweight or Obese
  • Type 2 Diabetes Mellitus (T2DM)
03

In context

Overweight

3,670 studies on the registry are indexed under Overweight; 850 are open to participants now.

This study's enrollment of 447 is above the median of 73 across 3,175 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

Carmot Therapeutics, Inc. is the lead sponsor of 7 studies on the registry; none are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
447 participants (actual)

Study arms

  • Placebo comparator
    Arm 1: Placebo

    Drug: Placebo

  • Experimental
    Arm 2: Enicepatide Dose Level 1 (Low)

    Drug: Enicepatide

  • Experimental
    Arm 3: Enicepatide Dose Level 2

    Drug: Enicepatide

  • Experimental
    Arm 4: Enicepatide Dose Level 3

    Drug: Enicepatide

  • Experimental
    Arm 5: Enicepatide Dose Level 4 (High)

    Drug: Enicepatide

Interventions

  • DrugPlacebo

    Placebo will be volume-matched and administered subcutaneously (SC) once weekly.

  • DrugEnicepatide

    Enicepatide will be administered subcutaneously (SC) once weekly at the randomized dosing regimen.

    Also known as: CT-388, RO7795068, RG6640

06

What researchers measure

Primary outcomes

  1. Percent Change in Body Weight from Baseline to Week 36

    Time frame: Baseline to Week 36

  2. Change in Glycated Hemoglobin (HbA1c) from Baseline to Week 36

    Time frame: Baseline to Week 36

Secondary outcomes

  1. Percent Change in Body Weight from Baseline to Week 48

    Time frame: Baseline to Week 48

  2. Change in HbA1c from Baseline to Week 48

    Time frame: Baseline to Week 48

  3. Percentage of Participants with HbA1c <7.0% at Weeks 36 and 48

    Time frame: Weeks 36 and 48

  4. Percentage of Participants with Body Weight Reduction ≥5%, ≥10%, ≥15%, ≥20%, and ≥25% from Baseline to Week 36

    Time frame: Baseline and Week 36

  5. Percentage of Participants with Body Weight Reduction ≥5%, ≥10%, ≥15%, ≥20%, and ≥25% from Baseline to Week 48

    Time frame: Baseline and Week 48

  6. Percent Change in Body Weight from Baseline to Week 28

    Time frame: Baseline and Week 28

  7. Absolute Change in Body Weight (kg) from Baseline to Weeks 36 and 48

    Time frame: Baseline to Weeks 36 and 48

  8. Percent Change in Body Weight from Baseline to Weeks 16, 28, 36, and 48 by Obesity Class

    Time frame: Baseline to Weeks 16, 28, 36, and 48

  9. Change in HbA1c from Baseline to Weeks 16 and 28

    Time frame: Baseline to Weeks 16 and 28

  10. Change in HbA1c from Baseline to Weeks 16, 28, 36, and 48 by Obesity Class

    Time frame: Baseline to Weeks 16, 28, 36, and 48

  11. Percentage of Participants with HbA1c ≤6.5% at Weeks 16, 28, 36, and 48

    Time frame: Weeks 16, 28, 36, and 48

  12. Percentage of Participants with HbA1c <5.7% at Weeks 16, 28, 36, and 48

    Time frame: Weeks 16, 28, 36, and 48

  13. Change in 7-point Self-Monitored Blood Glucose (SMBG) Profile at Weeks 16, 28, 36, and 48

    Time frame: Weeks 16, 28, 36, and 48

  14. Percentage of Participants who Achieve HbA1c ≤6.5% and ≥10.0% Weight Reduction at Weeks 16, 28, 36, and 48

    Time frame: Baseline, Weeks 16, 28, 36, and 48

  15. Percentage of Participants who Achieve HbA1c <7.0% and ≥5.0% Weight Reduction at Weeks 16, 28, 36, and 48

    Time frame: Baseline, Weeks 16, 28, 36, and 48

  16. Change in Body Mass Index (BMI) from Baseline to Weeks 36 and 48

    Time frame: Baseline, Weeks 36 and 48

  17. Change in Waist Circumference from Baseline to Weeks 36 and 48

    Time frame: Baseline, Weeks 36 and 48

  18. Change in Hip Circumference from Baseline to Weeks 36 and 48

    Time frame: Baseline, Weeks 36 and 48

  19. Change in Waist-to-Hip Ratio from Baseline to Weeks 36 and 48

    Time frame: Baseline, Weeks 36 and 48

  20. Change in Waist-to-Height Ratio from Baseline to Weeks 36 and 48

    Time frame: Baseline, Weeks 36 and 48

  21. Change in Fasting Plasma Glucose from Baseline to Weeks 16, 28, 36, and 48

    Time frame: Baseline to Weeks 16, 28, 36, and 48

  22. Change in Fasting Insulin from Baseline to Weeks 16, 28, 36, and 48

    Time frame: Baseline to Weeks 16, 28, 36, and 48

  23. Change in Fasting C-peptide from Baseline to Weeks 16, 28, 36, and 48

    Time frame: Baseline to Weeks 16, 28, 36, and 48

  24. Change in Fasting Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) from Baseline to Weeks 16, 28, 36, and 48

    Time frame: Baseline to Weeks 16, 28, 36, and 48

07

Study locations

70 sites
  • Central Alabama Research
    Birmingham, Alabama 35209-8401, United States
  • University of Alabama at Birmingham (UAB)
    Birmingham, Alabama 35233, United States
  • Lakeview Clinical Research, LLC
    Guntersville, Alabama 35976, United States
  • Yuma Clinical Trials
    Yuma, Arizona 85364, United States
  • AMCR Institute
    Escondido, California 92025, United States
  • Ark Clinical-Fountain Valley
    Fountain Valley, California 92708, United States
  • Orange Country Research Center
    Lake Forest, California 92630, United States
  • Ark Clinical Research
    Long Beach, California 90806, United States
  • Catalina Research Institute, LLC
    Montclair, California 91763, United States
  • Asclepes Research Centers
    Sherman Oaks, California 91403, United States
  • Encompass Clinical Research
    Spring Valley, California 91978, United States
  • Flourish Research - Boca Raton
    Boca Raton, Florida 33434, United States
  • Tampa Bay Medical Research
    Clearwater, Florida 33761, United States
  • K2 Medical Research, LLC - Maitland
    Maitland, Florida 32751, United States
  • K2 Medical Research, LLC - Orlando
    Maitland, Florida 32751, United States
  • Flourish Research Acquisition, LLC
    Miami, Florida 33138, United States
  • K2 Medical Research, LLC - South Orlando
    Orlando, Florida 32806, United States
  • Aging Well Associates
    St. Petersburg, Florida 33713, United States
  • K2 Medical Research Tampa
    Tampa, Florida 33607, United States
  • K2 Summit Research
    The Villages, Florida 32159, United States
  • Privia Medical Group Georgia, LLC
    Fayetteville, Georgia 30214, United States
  • Privia Medical Group Georgia - Thomasville
    Thomasville, Georgia 31792, United States
  • Rophe Adult and Pediatric Medicine/SKYCRNG
    Union City, Georgia 30291, United States
  • Duly Health and Care
    Lombard, Illinois 60148, United States
  • McFarland Clinic
    Ames, Iowa 50010, United States
  • Cotton O'Neil Clinical Research Center
    Topeka, Kansas 66606, United States
  • NOLA Cares, LLC
    Metairie, Louisiana 70006, United States
  • Flourish Research Acquisition, LLC dba Flourish Bowie
    Bowie, Maryland 20715, United States
  • Centennial Medical Group
    Elkridge, Maryland 21075, United States
  • NECCR PrimaCare Research LLC
    Fall River, Massachusetts 02721, United States
  • Olive Branch Family Medical Center; Family Medicine
    Olive Branch, Mississippi 38654, United States
  • SKY Integrative Medical Center/SKYCRNG
    Ridgeland, Mississippi 39157, United States
  • University of Nebraska Medical Center
    Omaha, Nebraska 68198, United States
  • Ellipsis Research Group
    Brooklyn, New York 11215, United States
  • Accellacare of Cary
    Cary, North Carolina 27518, United States
  • Accellacare - Hickory
    Hickory, North Carolina 28601, United States
  • Accellacare of Rocky Mount
    Rocky Mount, North Carolina 27804, United States
  • Accellacare of Piedmont Healthcare
    Statesville, North Carolina 28625, United States
  • Accellacare of Wilmington, LLC
    Wilmington, North Carolina 28401, United States
  • Accellacare Research of Winston Salem
    Winston-Salem, North Carolina 27103, United States
  • Diabetes and Endocrinology Associates of Stark County, Inc.
    Canton, Ohio 44718, United States
  • Tekton Research
    Edmond, Oklahoma 73013, United States
  • Roper St. Francis Physician Partners - Primary Care
    Mt. Pleasant, South Carolina 29464, United States
  • Norwood Family Medicine
    Knoxville, Tennessee 37912, United States
  • Summit-Halls Family Practice
    Knoxville, Tennessee 37938, United States
  • FutureSearch Trials of Neurology
    Austin, Texas 78731, United States
  • Velocity Clinical Research - Dallas
    Dallas, Texas 75230, United States
  • University of Texas Southwestern Medical Center Investigation Drug Services
    Dallas, Texas 75390, United States
  • Juno Research, LLC
    Houston, Texas 77040, United States
  • Consano Clinical Research
    Shavano Park, Texas 78231, United States
  • Privia Medical Group North Texas - Stephenville
    Stephenville, Texas 76401, United States
  • Manassas Clinical Research Center
    Manassas, Virginia 20110, United States
  • Centro Medico Viamonte SRL
    Buenos Aires, Provincia de Buenos 1120, Argentina
  • Centricity Research Brampton Endocrinology
    Brampton, Ontario L6S 0C6, Canada
  • Aggarwal and Associates
    Brampton, Ontario L6T 0G1, Canada
  • CEMDEC S.A. de C.V.
    Cuauhtémoc, 06100, Mexico
  • Instituto de Diabetes Obesidad y Nutricion, SC
    Cuernavaca, 62250, Mexico
  • SINACOR
    Culiacán, 80230, Mexico
  • Centro De Investigacion En Artritis Y Osteopososis
    Mexicali, 21200, Mexico
  • Clinicos Asociados Bocm, S.C.
    Mexico City, 03300, Mexico
  • Medical Care and Research S.A de C.V
    Mérida, 97070, Mexico
  • Avant Santé Research Center
    San Pedro Garza García, 66260, Mexico
  • Sociedad de Metabolismo y Corazon S.C.
    Veracruz, 91855, Mexico
  • FAICIC S de R.L. de C.V
    Veracruz, 91900, Mexico
  • Optimal Clinical Trials - North
    Rosedale, Auckland 0632, New Zealand
  • Momentum Pukekohe
    Auckland, 2120, New Zealand
  • Optimal Clinical Trials
    Grafton, 1010, New Zealand
  • Tauranga Hospital
    Tauranga, 3110, New Zealand
  • Momentum Wellington
    Wellington, 6021, New Zealand
  • ISIS Clinical Research Center
    Guaynabo, 00970, Puerto Rico
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Status
Active, not recruiting→Completed
changed Oct 6, 2026
Study completion
Sep 24, 2026→Sep 30, 2026 (actual)
Oct 6, 2026
Show all 1 update
  1. Oct 6, 2026
    Active, not recruiting→Completed
    Study completion Sep 24, 2026→Sep 30, 2026 (now actual)
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06628362
Lead sponsor
Carmot Therapeutics, Inc.
Collaborators
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Oct 8, 2024
Start date
Nov 21, 2024
Primary completion
May 29, 2026
Completion
Sep 30, 2026
Last update
Oct 6, 2026

Study contacts

Clinical Trials
study director · Carmot Therapeutics, Inc., a Member of the Roche Group

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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