Overweight or ObesePhase 2NCT06628362
A Study of Enicepatide (CT-388) in Participants Who Are Overweight or Obese With Type 2 Diabetes Mellitus
A Phase 2 study testing Enicepatide in people with Overweight or Obese and Type 2 Diabetes Mellitus (T2DM), run by Carmot Therapeutics, Inc. at 70 sites in 6 countries.
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 who are overweight or obese with Type 2 diabetes mellitus (T2DM). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Overweight or Obese, Type 2 Diabetes Mellitus (T2DM)
- 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
- 447 participants
- Where
- 70 sitesin 6 countries
- Study dates
- 21 Nov 2024to 2 Oct 2026
- 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) ≥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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
70 sites in 6 countries.
70 sites in 6 countries
United States52 sites
McFarland Clinic
Ames, Iowa, 50010
FutureSearch Trials of Neurology
Austin, Texas, 78731
Central Alabama Research
Birmingham, Alabama, 35209-8401
University of Alabama at Birmingham (UAB)
Birmingham, Alabama, 35233
Flourish Research - Boca Raton
Boca Raton, Florida, 33434
Flourish Research Acquisition, LLC dba Flourish Bowie
Bowie, Maryland, 20715
Ellipsis Research Group
Brooklyn, New York, 11215
Diabetes and Endocrinology Associates of Stark County, Inc.
Canton, Ohio, 44718
Accellacare of Cary
Cary, North Carolina, 27518
Tampa Bay Medical Research
Clearwater, Florida, 33761
Velocity Clinical Research - Dallas
Dallas, Texas, 75230
University of Texas Southwestern Medical Center Investigation Drug Services
Dallas, Texas, 75390
Tekton Research
Edmond, Oklahoma, 73013
Centennial Medical Group
Elkridge, Maryland, 21075
AMCR Institute
Escondido, California, 92025
NECCR PrimaCare Research LLC
Fall River, Massachusetts, 02721
Privia Medical Group Georgia, LLC
Fayetteville, Georgia, 30214
Ark Clinical-Fountain Valley
Fountain Valley, California, 92708
Lakeview Clinical Research, LLC
Guntersville, Alabama, 35976
Accellacare - Hickory
Hickory, North Carolina, 28601
Juno Research, LLC
Houston, Texas, 77040
Norwood Family Medicine
Knoxville, Tennessee, 37912
Summit-Halls Family Practice
Knoxville, Tennessee, 37938
Orange Country Research Center
Lake Forest, California, 92630
Duly Health and Care
Lombard, Illinois, 60148
Ark Clinical Research
Long Beach, California, 90806
K2 Medical Research, LLC - Maitland
Maitland, Florida, 32751
K2 Medical Research, LLC - Orlando
Maitland, Florida, 32751
Manassas Clinical Research Center
Manassas, Virginia, 20110
NOLA Cares, LLC
Metairie, Louisiana, 70006
Flourish Research Acquisition, LLC
Miami, Florida, 33138
Catalina Research Institute, LLC
Montclair, California, 91763
Roper St. Francis Physician Partners - Primary Care
Mt. Pleasant, South Carolina, 29464
Olive Branch Family Medical Center; Family Medicine
Olive Branch, Mississippi, 38654
University of Nebraska Medical Center
Omaha, Nebraska, 68198
K2 Medical Research, LLC - South Orlando
Orlando, Florida, 32806
SKY Integrative Medical Center/SKYCRNG
Ridgeland, Mississippi, 39157
Accellacare of Rocky Mount
Rocky Mount, North Carolina, 27804
Consano Clinical Research
Shavano Park, Texas, 78231
Asclepes Research Centers
Sherman Oaks, California, 91403
Encompass Clinical Research
Spring Valley, California, 91978
Aging Well Associates
St. Petersburg, Florida, 33713
Accellacare of Piedmont Healthcare
Statesville, North Carolina, 28625
Privia Medical Group North Texas - Stephenville
Stephenville, Texas, 76401
K2 Medical Research Tampa
Tampa, Florida, 33607
K2 Summit Research
The Villages, Florida, 32159
Privia Medical Group Georgia - Thomasville
Thomasville, Georgia, 31792
Cotton O'Neil Clinical Research Center
Topeka, Kansas, 66606
Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, Georgia, 30291
Accellacare of Wilmington, LLC
Wilmington, North Carolina, 28401
Accellacare Research of Winston Salem
Winston-Salem, North Carolina, 27103
Yuma Clinical Trials
Yuma, Arizona, 85364
Mexico9 sites
CEMDEC S.A. de C.V.
Cuauhtémoc, 06100
Instituto de Diabetes Obesidad y Nutricion, SC
Cuernavaca, 62250
SINACOR
Culiacán, 80230
Medical Care and Research S.A de C.V
Mérida, 97070
Centro De Investigacion En Artritis Y Osteopososis
Mexicali, 21200
Clinicos Asociados Bocm, S.C.
Mexico City, 03300
Avant Santé Research Center
San Pedro Garza García, 66260
Sociedad de Metabolismo y Corazon S.C.
Veracruz, 91855
FAICIC S de R.L. de C.V
Veracruz, 91900
New Zealand5 sites
Momentum Pukekohe
Auckland, 2120
Optimal Clinical Trials
Grafton, 1010
Optimal Clinical Trials - North
Rosedale, Auckland, 0632
Tauranga Hospital
Tauranga, 3110
Momentum Wellington
Wellington, 6021
Canada2 sites
Centricity Research Brampton Endocrinology
Brampton, Ontario, L6S 0C6
Aggarwal and Associates
Brampton, Ontario, L6T 0G1
Argentina1 site
Centro Medico Viamonte SRL
Buenos Aires, Provincia de Buenos, 1120
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 Subcutaneously for 48 Weeks to Participants Who Are Overweight or Obese With Type 2 Diabetes Mellitus
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).
- Being tested
- Placebo, Enicepatide
- Medical subject headings
- Overweight, Obesity, Diabetes Mellitus, Type 2
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 | Not described Receives: Drug: Placebo |
| Arm 2: Enicepatide Dose Level 1 (Low) | Experimental | Not described Receives: Drug: Enicepatide |
| Arm 3: Enicepatide Dose Level 2 | Experimental | Not described Receives: Drug: Enicepatide |
| Arm 4: Enicepatide Dose Level 3 | Experimental | Not described Receives: Drug: Enicepatide |
| Arm 5: Enicepatide Dose Level 4 (High) | Experimental | Not described 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 36
Measured: Baseline to Week 36
Change in Glycated Hemoglobin (HbA1c) from Baseline to Week 36
Measured: Baseline to Week 36
Secondary outcomes (24)
Percent Change in Body Weight from Baseline to Week 48
Measured: Baseline to Week 48
Change in HbA1c from Baseline to Week 48
Measured: Baseline to Week 48
Percentage of Participants with HbA1c <7.0% at Weeks 36 and 48
Measured: Weeks 36 and 48
Percentage of Participants with Body Weight Reduction ≥5%, ≥10%, ≥15%, ≥20%, and ≥25% from Baseline to Week 36
Measured: Baseline and Week 36
Percentage of Participants with Body Weight Reduction ≥5%, ≥10%, ≥15%, ≥20%, and ≥25% from Baseline to Week 48
Measured: Baseline and Week 48
Percent Change in Body Weight from Baseline to Week 28
Measured: Baseline and Week 28
Absolute Change in Body Weight (kg) from Baseline to Weeks 36 and 48
Measured: Baseline to Weeks 36 and 48
Percent Change in Body Weight from Baseline to Weeks 16, 28, 36, and 48 by Obesity Class
Measured: Baseline to Weeks 16, 28, 36, and 48
Change in HbA1c from Baseline to Weeks 16 and 28
Measured: Baseline to Weeks 16 and 28
Change in HbA1c from Baseline to Weeks 16, 28, 36, and 48 by Obesity Class
Measured: Baseline to Weeks 16, 28, 36, and 48
Percentage of Participants with HbA1c ≤6.5% at Weeks 16, 28, 36, and 48
Measured: Weeks 16, 28, 36, and 48
Percentage of Participants with HbA1c <5.7% at Weeks 16, 28, 36, and 48
Measured: Weeks 16, 28, 36, and 48
Change in 7-point Self-Monitored Blood Glucose (SMBG) Profile at Weeks 16, 28, 36, and 48
Measured: Weeks 16, 28, 36, and 48
Percentage of Participants who Achieve HbA1c ≤6.5% and ≥10.0% Weight Reduction at Weeks 16, 28, 36, and 48
Measured: Baseline, Weeks 16, 28, 36, and 48
Percentage of Participants who Achieve HbA1c <7.0% and ≥5.0% Weight Reduction at Weeks 16, 28, 36, and 48
Measured: Baseline, Weeks 16, 28, 36, and 48
Change in Body Mass Index (BMI) from Baseline to Weeks 36 and 48
Measured: Baseline, Weeks 36 and 48
Change in Waist Circumference from Baseline to Weeks 36 and 48
Measured: Baseline, Weeks 36 and 48
Change in Hip Circumference from Baseline to Weeks 36 and 48
Measured: Baseline, Weeks 36 and 48
Change in Waist-to-Hip Ratio from Baseline to Weeks 36 and 48
Measured: Baseline, Weeks 36 and 48
Change in Waist-to-Height Ratio from Baseline to Weeks 36 and 48
Measured: Baseline, Weeks 36 and 48
Change in Fasting Plasma Glucose from Baseline to Weeks 16, 28, 36, and 48
Measured: Baseline to Weeks 16, 28, 36, and 48
Change in Fasting Insulin from Baseline to Weeks 16, 28, 36, and 48
Measured: Baseline to Weeks 16, 28, 36, and 48
Change in Fasting C-peptide from Baseline to Weeks 16, 28, 36, and 48
Measured: Baseline to Weeks 16, 28, 36, and 48
Change in Fasting Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) from Baseline to Weeks 16, 28, 36, and 48
Measured: Baseline to Weeks 16, 28, 36, and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start21 Nov 2024
- Primary completion29 May 2026
- Study completion2 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight or ObeseStudies 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
- 447 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
- NCT06628362
- Sponsor's protocol ID
- CT-388-104
- Other IDs
- XC45544
- Status last verified
- Oct 2026
- First submitted
- 3 Oct 2024
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 28 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 Subcutaneously for 48 Weeks to Participants Who Are Overweight or Obese With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06628362
- Acronym / sponsor ID
- CT-388-104
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 447 participants (actual)
- Lead sponsor
- Carmot Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Hoffmann-La Roche
- Study start
- 21 Nov 2024 (actual)
- Primary completion
- 29 May 2026 (actual)
- Study completion
- 2 Oct 2026 (actual)
- First posted
- 8 Oct 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 who are overweight or obese with Type 2 diabetes mellitus (T2DM).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Placebo | Placebo comparator | Drug: Placebo |
| Arm 2: Enicepatide Dose Level 1 (Low) | Experimental | Drug: Enicepatide |
| Arm 3: Enicepatide Dose Level 2 | Experimental | Drug: Enicepatide |
| Arm 4: Enicepatide Dose Level 3 | Experimental | Drug: Enicepatide |
| Arm 5: Enicepatide Dose Level 4 (High) | Experimental | Drug: Enicepatide |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (18 listed)
- 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
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 (High) |
Primary outcome
Percent Change in Body Weight from Baseline to Week 36
Time frame: Baseline to Week 36
Change in Glycated Hemoglobin (HbA1c) from Baseline to Week 36
Time frame: Baseline to Week 36
24 secondary outcomes
Percent Change in Body Weight from Baseline to Week 48
Time frame: Baseline to Week 48
Change in HbA1c from Baseline to Week 48
Time frame: Baseline to Week 48
Percentage of Participants with HbA1c <7.0% at Weeks 36 and 48
Time frame: Weeks 36 and 48
Percentage of Participants with Body Weight Reduction ≥5%, ≥10%, ≥15%, ≥20%, and ≥25% from Baseline to Week 36
Time frame: Baseline and Week 36
Percentage of Participants with Body Weight Reduction ≥5%, ≥10%, ≥15%, ≥20%, and ≥25% from Baseline to Week 48
Time frame: Baseline and Week 48
Percent Change in Body Weight from Baseline to Week 28
Time frame: Baseline and Week 28
Absolute Change in Body Weight (kg) from Baseline to Weeks 36 and 48
Time frame: Baseline to Weeks 36 and 48
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
Change in HbA1c from Baseline to Weeks 16 and 28
Time frame: Baseline to Weeks 16 and 28
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
Percentage of Participants with HbA1c ≤6.5% at Weeks 16, 28, 36, and 48
Time frame: Weeks 16, 28, 36, and 48
Percentage of Participants with HbA1c <5.7% at Weeks 16, 28, 36, and 48
Time frame: Weeks 16, 28, 36, and 48
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
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
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
Change in Body Mass Index (BMI) from Baseline to Weeks 36 and 48
Time frame: Baseline, Weeks 36 and 48
Change in Waist Circumference from Baseline to Weeks 36 and 48
Time frame: Baseline, Weeks 36 and 48
Change in Hip Circumference from Baseline to Weeks 36 and 48
Time frame: Baseline, Weeks 36 and 48
Change in Waist-to-Hip Ratio from Baseline to Weeks 36 and 48
Time frame: Baseline, Weeks 36 and 48
Change in Waist-to-Height Ratio from Baseline to Weeks 36 and 48
Time frame: Baseline, Weeks 36 and 48
Change in Fasting Plasma Glucose from Baseline to Weeks 16, 28, 36, and 48
Time frame: Baseline to Weeks 16, 28, 36, and 48
Change in Fasting Insulin from Baseline to Weeks 16, 28, 36, and 48
Time frame: Baseline to Weeks 16, 28, 36, and 48
Change in Fasting C-peptide from Baseline to Weeks 16, 28, 36, and 48
Time frame: Baseline to Weeks 16, 28, 36, and 48
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
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 28 Oct 2026.
- Individual participant dataSharing planned: No
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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
70 sites in 6 countries: 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 Overweight or Obese and Type 2 Diabetes Mellitus (T2DM), run by Carmot Therapeutics, Inc. at 70 sites in 6 countries.
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 6 inclusion and 18 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 28 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 70 sites in United States, Mexico, New Zealand, Canada, Argentina and 1 more country. 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 36 (time frame: Baseline to Week 36). The study lists 2 primary outcomes in all. 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 28 Oct 2026.