ObesityPhase 2NCT06525935
A Study of Enicepatide (CT-388) in Participants With Obesity or Overweight With at Least One Weight-Related Comorbidity
A Phase 2 study testing Enicepatide in people with Obesity and Overweight, run by Carmot Therapeutics, Inc. at 34 sites in United States.
Trial 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 with obesity or who are overweight with at least one weight-related comorbidity. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Enicepatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 469 participants
- Where
- 34 sitesUnited States
- Study dates
- 16 Aug 2024to 8 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, 18 to 75 years of age
- Body mass index (BMI) ≥30.0 kg/m2, OR BMI ≥27.0 and <30.0 kg/m2 and previously diagnosed with at least 1 of the following weight-related comorbidities, such as: prediabetes, hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease
- At least one self-reported unsuccessful effort to lose body weight
Who cannot join
- Prior history/diagnosis/lab evidence of any type of diabetes mellitus (e.g., Type 1, Type 2, gestational), or a history of ketoacidosis or hyperosmolar state
- Self-reported body weight change of >5 kg within 3 months before randomization
- Any unbalanced/extreme 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
Show all 14Show fewer
- 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, or any history/diagnosis of other severe psychiatric conditions (Note: Prospective participants with depression or anxiety whose disease state, in the opinion of the Investigator, is considered stable and expected to remain stable throughout the course of the study, may be considered for inclusion)
- Family or personal history of medullary thyroid carcinoma
- Serum calcitonin ≥ 20 ng/L
- Women who are pregnant, breastfeeding, or intend to become pregnant, or are of childbearing potential and not using a highly effective contraceptive method
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
United States34 sites
Amicis Research Center - Anaheim
Anaheim, California, 92801
Texas Diabetes & Endocrinology, P.A.
Austin, Texas, 78731
Apex Mobile Clinical Research
Bellaire, Texas, 77401
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, 35235
Mercury Street Medical Group
Butte, Montana, 59701
Neurobehavioral Research, Inc. (NBR)
Cedarhurst, New York, 11516
Velocity Clinical Research - Cincinnati
Cincinnati, Ohio, 45242
Tampa Bay Medical Research, Inc.
Clearwater, Florida, 33761
Velocity Clinical Research - Dallas
Dallas, Texas, 75230
FutureSearch Trials of Dallas, LLC
Dallas, Texas, 75231
University of Texas Southwestern
Dallas, Texas, 75390
Velocity Clinical Research, Providence
East Greenwich, Rhode Island, 02818
Ark Clinical-Fountain Valley
Fountain Valley, California, 92708
Tribe Clinical Research
Greenville, South Carolina, 29607
Central Alabama Research
Homewood, Alabama, 35209
The Center for Pharmaceutical Research
Kansas City, Missouri, 64114
Alliance for Multispecialty Research, LLC
Knoxville, Tennessee, 37920
Ark Clinical Research - Long Beach
Long Beach, California, 90806
Velocity Clinical Research - Los Angeles
Los Angeles, California, 90057
Louisville Metabolic and Atherosclerosis Research Center (L-MARC)
Louisville, Kentucky, 40213
The Institute for Liver Health II LLC dba Arizona Clinical Trials; Arizona Liver Health
Mesa, Arizona, 85210
Lucas Research, Inc
Morehead City, North Carolina, 28557
Clinical Research Associates, Inc.
Nashville, Tennessee, 37203
Infinity Clinical Research
Norco, California, 92860
Amicis Research Center
Northridge, California, 91324
Progressive Medical Research
Port Orange, Florida, 32127
Prospective Research Innovations Inc.
Rancho Cucamonga, California, 91730
National Clinical Research - Richmond, Inc
Richmond, Virginia, 23294
Pinnacle Clinical Research
San Antonio, Texas, 78229
Elevate Clinical
Seabrook, Texas, 77586
Chrysalis Clinical Research
St. George, Utah, 84790
Orange County Research Center
Tustin, California, 92780
Impact Research Institute
Waco, Texas, 76710
Amicis Research Center - West Hills
West Hills, California, 91307
About this study
Official title: 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 for 48 Weeks to Participants With Obesity or Overweight With at Least One Weight-Related Comorbidity
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 with obesity or who are overweight with at least one weight-related comorbidity.
- Conditions
- Obesity, Overweight
- Being tested
- Placebo, Enicepatide
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo will be volume- matched and administered subcutaneously (SC) once weekly.
EnicepatideDrug
Also called CT-388, RO7795068, RG6640
Enicepatide will be administered subcutaneously (SC) once weekly at the randomized dosing regimen.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Placebo | Placebo comparator | Placebo administered subcutaneously (SC) once weekly. Receives: Drug: Placebo |
| Arm 2: Enicepatide Dose Level 1 (Low) | Experimental | Enicepatide Dose Level 1 administered SC once weekly. Receives: Drug: Enicepatide |
| Arm 3: Enicepatide Dose Level 2 | Experimental | Enicepatide Dose Level 2 administered SC once weekly. Receives: Drug: Enicepatide |
| Arm 4: Enicepatide Dose Level 3 | Experimental | Enicepatide Dose Level 3 administered SC once weekly. Receives: Drug: Enicepatide |
| Arm 5: Enicepatide Dose Level 4 | Experimental | Enicepatide Dose Level 4 administered SC once weekly. Receives: Drug: Enicepatide |
| Arm 6: Enicepatide Dose Level 5 (High) | Experimental | Enicepatide Dose Level 5 administered SC once weekly. Receives: Drug: Enicepatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Body Weight from Baseline to Week 48
Measured: Baseline to Week 48
Secondary outcomes (15)
Percentage of Participants with Body Weight Reduction ≥5%, ≥10%, ≥15%, ≥20%, and ≥25% from Baseline to Week 48
Measured: Baseline and Week 48
Absolute Change in Body Weight (kg) from Baseline to Week 48
Measured: Baseline to Week 48
Percent Change in Body Weight from Baseline to Week 48 by Obesity Class
Measured: Baseline to Week 48
Change in Body Mass Index (BMI) from Baseline to Week 48
Measured: Baseline to Week 48
Change in Waist Circumference from Baseline to Week 48
Measured: Baseline to Week 48
Change in Hip Circumference from Baseline to Week 48
Measured: Baseline to Week 48
Change in Waist-to-Hip Ratio from Baseline to Week 48
Measured: Baseline to Week 48
Change in Waist-to-Height Ratio from Baseline to Week 48
Measured: Baseline to Week 48
Change in Glycated Hemoglobin (HbA1c) from Baseline to Week 48
Measured: Baseline to Week 48
Change in Fasting Plasma Glucose from Baseline to Week 48
Measured: Baseline to Week 48
Change in Fasting Insulin from Baseline to Week 48
Measured: Baseline to Week 48
Change in Fasting C-peptide from Baseline to Week 48
Measured: Baseline to Week 48
Change in Fasting Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) from Baseline to Week 48
Measured: Baseline to Week 48
Change in Quantitative Insulin Sensitivity Check Index (QUICKI) from Baseline to Week 48
Measured: Baseline to Week 48
Percentage of Participants with Shift in Glycemic Status from Baseline to Week 48, Based on Fasting Plasma Glucose and HbA1c
Measured: Baseline and Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start16 Aug 2024
- Primary completion8 Dec 2025
- Study completion8 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 469 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carmot Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Carmot Therapeutics, Inc., a Member of the Roche Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06525935
- Sponsor's protocol ID
- CT-388-103
- Other IDs
- XC45526
- Status last verified
- Oct 2026
- First submitted
- 23 Jul 2024
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 for 48 Weeks to Participants With Obesity or Overweight With at Least One Weight-Related Comorbidity
- ClinicalTrials.gov ID
- NCT06525935
- Acronym / sponsor ID
- CT-388-103
- Conditions
- Obesity, Overweight
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 469 participants (actual)
- Lead sponsor
- Carmot Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Hoffmann-La Roche
- Study start
- 16 Aug 2024 (actual)
- Primary completion
- 8 Dec 2025 (actual)
- Study completion
- 8 Dec 2025 (actual)
- First posted
- 29 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 with obesity or who are overweight with at least one weight-related comorbidity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Placebo | Placebo comparator | Drug: PlaceboPlacebo administered subcutaneously (SC) once weekly. |
| Arm 2: Enicepatide Dose Level 1 (Low) | Experimental | Drug: EnicepatideEnicepatide Dose Level 1 administered SC once weekly. |
| Arm 3: Enicepatide Dose Level 2 | Experimental | Drug: EnicepatideEnicepatide Dose Level 2 administered SC once weekly. |
| Arm 4: Enicepatide Dose Level 3 | Experimental | Drug: EnicepatideEnicepatide Dose Level 3 administered SC once weekly. |
| Arm 5: Enicepatide Dose Level 4 | Experimental | Drug: EnicepatideEnicepatide Dose Level 4 administered SC once weekly. |
| Arm 6: Enicepatide Dose Level 5 (High) | Experimental | Drug: EnicepatideEnicepatide Dose Level 5 administered SC once weekly. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female, 18 to 75 years of age
- Body mass index (BMI) ≥30.0 kg/m2, OR BMI ≥27.0 and <30.0 kg/m2 and previously diagnosed with at least 1 of the following weight-related comorbidities, such as: prediabetes, hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease
- At least one self-reported unsuccessful effort to lose body weight
Key exclusion criteria (14 listed)
- Prior history/diagnosis/lab evidence of any type of diabetes mellitus (e.g., Type 1, Type 2, gestational), or a history of ketoacidosis or hyperosmolar state
- Self-reported body weight change of >5 kg within 3 months before randomization
- Any unbalanced/extreme 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo will be volume- matched and administered subcutaneously (SC) once weekly. | Drug | Arm 1: Placebo |
| EnicepatideAlso: CT-388, RO7795068, RG6640Enicepatide will be administered subcutaneously (SC) once weekly at the randomized dosing regimen. | Drug | Arm 2: Enicepatide Dose Level 1 (Low), Arm 3: Enicepatide Dose Level 2, Arm 4: Enicepatide Dose Level 3, Arm 5: Enicepatide Dose Level 4, Arm 6: Enicepatide Dose Level 5 (High) |
Primary outcome
Percent Change in Body Weight from Baseline to Week 48
Time frame: Baseline to Week 48
15 secondary outcomes
Percentage of Participants with Body Weight Reduction ≥5%, ≥10%, ≥15%, ≥20%, and ≥25% from Baseline to Week 48
Time frame: Baseline and Week 48
Absolute Change in Body Weight (kg) from Baseline to Week 48
Time frame: Baseline to Week 48
Percent Change in Body Weight from Baseline to Week 48 by Obesity Class
Time frame: Baseline to Week 48
Change in Body Mass Index (BMI) from Baseline to Week 48
Time frame: Baseline to Week 48
Change in Waist Circumference from Baseline to Week 48
Time frame: Baseline to Week 48
Change in Hip Circumference from Baseline to Week 48
Time frame: Baseline to Week 48
Change in Waist-to-Hip Ratio from Baseline to Week 48
Time frame: Baseline to Week 48
Change in Waist-to-Height Ratio from Baseline to Week 48
Time frame: Baseline to Week 48
Change in Glycated Hemoglobin (HbA1c) from Baseline to Week 48
Time frame: Baseline to Week 48
Change in Fasting Plasma Glucose from Baseline to Week 48
Time frame: Baseline to Week 48
Change in Fasting Insulin from Baseline to Week 48
Time frame: Baseline to Week 48
Change in Fasting C-peptide from Baseline to Week 48
Time frame: Baseline to Week 48
Change in Fasting Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) from Baseline to Week 48
Time frame: Baseline to Week 48
Change in Quantitative Insulin Sensitivity Check Index (QUICKI) from Baseline to Week 48
Time frame: Baseline to Week 48
Percentage of Participants with Shift in Glycemic Status from Baseline to Week 48, Based on Fasting Plasma Glucose and HbA1c
Time frame: Baseline and Week 48
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Carmot Therapeutics, Inc., a Member of the Roche Group
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Enicepatide in people with Obesity and Overweight, run by Carmot Therapeutics, Inc. at 34 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Body Weight from Baseline to Week 48 (time frame: Baseline to Week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.