ObesityPhase 2NCT05110846
A Study of CT-868 in Overweight and Obese Participants With Type 2 Diabetes Mellitus
A Phase 2 study testing CT-868 in people with Obesity and Overweight, run by Carmot Therapeutics, Inc. at 5 sites in Mexico.
Trial summary
A study to assess the effect of CT-868 in lowering glycated hemoglobin A1c (HbA1c) in overweight and obese participants with inadequately controlled Type 2 diabetes mellitus (T2DM). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity, Overweight, Type 2 Diabetes Mellitus
- What is being tested?
- CT-868
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 5 sitesMexico
- Study dates
- 22 Feb 2022to 28 Feb 2023
- 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
- Males or Females with T2DM
- BMI of ≥27 kg/m2, inclusive
- 18-75 years old, inclusive
- Stable body weight for 3 months
Who cannot join
- Significant medical history
- Uncontrolled diabetes
- History of malignancy
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Mexico5 sites
Carmot Clinical Center MX04
Guadalajara, Jalisco
Carmot Clinical Center MX05
Mérida, Yucatán
Carmot Clinical Center MX03
Mexico City
Carmot Clinical Center MX01
Monterrey, Nuevo León
Carmot Clinical Center MX02
Monterrey, Nuevo León
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multiple-Center Study to Evaluate the Efficacy, Safety, and Tolerability of CT-868 Administered for 26 Weeks to Overweight and Obese Participants With Type 2 Diabetes Mellitus
A study to assess the effect of CT-868 in lowering glycated hemoglobin A1c (HbA1c) in overweight and obese participants with inadequately controlled Type 2 diabetes mellitus (T2DM).
- Conditions
- Obesity, Overweight, Type 2 Diabetes Mellitus
- Being tested
- Placebo, CT-868
- Medical subject headings
- Obesity, Overweight, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Participants self-injected once-daily subcutaneous volume- and regimen-matched placebo for 26 weeks.
CT-868Drug
Participants self-injected once-daily subcutaneous CT-868 for 26 weeks according to the randomized dose and regimen.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants in the placebo arm received volume- and regimen-matched placebo. Receives: Drug: Placebo |
| CT-868 1.75 mg | Experimental | Participants in the CT-868 1.75 mg arm received 1.0 mg/day for 2 weeks followed by 1.75 mg/day for the remaining treatment period. Receives: Drug: CT-868 |
| CT-868 4.0 mg | Experimental | Participants in the CT-868 4.0 mg arm escalated through 1.0 mg/day for 2 weeks, 1.75 mg/day for 2 weeks, 2.5 mg/day for 4 weeks, 3.25 mg/day for 4 weeks, to 4.0 mg/day for the remaining 14 weeks. Receives: Drug: CT-868 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Glycated Hemoglobin A1c (HbA1c) at Week 26
Measured: Baseline and Week 26
Secondary outcomes (28)
Change from Baseline in HbA1c at Week 12
Measured: Baseline and Week 12
Percentage of Participants Achieving HbA1c <5.7% at Weeks 12 and 26
Measured: Baseline and Weeks 12 and 26
Percentage of Participants Achieving HbA1c ≤6.5% at Weeks 12 and 26
Measured: Baseline and Weeks 12 and 26
Percentage of Participants Achieving HbA1c <7.0% at Weeks 12 and 26
Measured: Baseline and Weeks 12 and 26
Percent Change from Baseline in Body Weight at Weeks 12 and 26
Measured: Baseline and Weeks 12 and 26
Absolute (kg) Change from Baseline in Body Weight at Weeks 12 and 26
Measured: Baseline and Weeks 12 and 26
Percentage of Participants with ≥5% Body Weight Loss from Baseline at Weeks 12 and 26
Measured: Baseline and Weeks 12 and 26
Percentage of Participants with ≥10% Body Weight Loss from Baseline at Weeks 12 and 26
Measured: Baseline and Weeks 12 and 26
Percentage of Participants with ≥15% Body Weight Loss from Baseline at Weeks 12 and 26
Measured: Baseline and Weeks 12 and 26
Percentage of Participants with ≥20% Body Weight Loss from Baseline at Weeks 12 and 26
Measured: Baseline and Weeks 12 and 26
Change from Baseline in Fasting Plasma Glucose at Weeks 12 and 26
Measured: Baseline and Weeks 12 and 26
Change from Baseline in Fasting Insulin at Weeks 12 and 26
Measured: Baseline and Weeks 12 and 26
Change from Baseline in Waist Circumference at Weeks 12 and 26
Measured: Baseline and Weeks 12 and 26
Change from Baseline in Hip Circumference at Weeks 12 and 26
Measured: Baseline and Weeks 12 and 26
Change from Baseline in Waist-to-Hip Ratio at Weeks 12 and 26
Measured: Baseline and Weeks 12 and 26
Change from Baseline in Waist-to-Height Ratio at Weeks 12 and 26
Measured: Baseline and Weeks 12 and 26
Change from Baseline in Body Mass Index (BMI) at Weeks 12 and 26
Measured: Baseline and Weeks 12 and 26
Change from Baseline in Total Cholesterol at Weeks 12 and 26
Measured: Baseline and Weeks 12 and 26
Change from Baseline in Triglycerides at Weeks 12 and 26
Measured: Baseline and Weeks 12 and 26
Change from Baseline in Low Density Lipoprotein (LDL) Cholesterol at Weeks 12 and 26
Measured: Baseline and Weeks 12 and 26
Change from Baseline in High Density Lipoprotein (HDL) Cholesterol at Weeks 12 and 26
Measured: Baseline and Weeks 12 and 26
Change from Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Weeks 12 and 26
Measured: Baseline and Weeks 12 and 26
Change from Baseline in Apolipoprotein B at Weeks 12 and 26
Measured: Baseline and Weeks 12 and 26
Change from Baseline in Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) at Weeks 12 and 26
Measured: Baseline and Weeks 12 and 26
Change from Baseline in Quantitative Insulin Sensitivity Check Index (QUICKI) at Weeks 12 and 26
Measured: Baseline and Weeks 12 and 26
Percentage of Participants with at Least One Treatment-Emergent Adverse Event
Measured: From first dose of study drug until 4 weeks after the last dose of study drug (30 weeks)
Percentage of Participants with at Least One Hypoglycemic Event
Measured: From first dose of study drug until 4 weeks after the last dose of study drug (30 weeks)
Percentage of Participants Testing Positive for Anti-Drug Antibodies to CT-868 at Baseline and Anytime Post-Baseline
Measured: Baseline and Post-Baseline (up to 30 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start22 Feb 2022
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 103 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
- NCT05110846
- Sponsor's protocol ID
- CT-868-002
- Other IDs
- BP45664
- Status last verified
- Feb 2026
- First submitted
- 4 Nov 2021
- Last updated
- 5 Feb 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 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multiple-Center Study to Evaluate the Efficacy, Safety, and Tolerability of CT-868 Administered for 26 Weeks to Overweight and Obese Participants With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05110846
- Acronym / sponsor ID
- CT-868-002
- Conditions
- Obesity, Overweight, Type 2 Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Carmot Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Hoffmann-La Roche
- Study start
- 22 Feb 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 8 Nov 2021 (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.
A study to assess the effect of CT-868 in lowering glycated hemoglobin A1c (HbA1c) in overweight and obese participants with inadequately controlled Type 2 diabetes mellitus (T2DM).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboParticipants in the placebo arm received volume- and regimen-matched placebo. |
| CT-868 1.75 mg | Experimental | Drug: CT-868Participants in the CT-868 1.75 mg arm received 1.0 mg/day for 2 weeks followed by 1.75 mg/day for the remaining treatment period. |
| CT-868 4.0 mg | Experimental | Drug: CT-868Participants in the CT-868 4.0 mg arm escalated through 1.0 mg/day for 2 weeks, 1.75 mg/day for 2 weeks, 2.5 mg/day for 4 weeks, 3.25 mg/day for 4 weeks, to 4.0 mg/day for the remaining 14 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males or Females with T2DM
- BMI of ≥27 kg/m2, inclusive
- 18-75 years old, inclusive
- Stable body weight for 3 months
Key exclusion criteria (3 listed)
- Significant medical history
- Uncontrolled diabetes
- History of malignancy
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 |
|---|---|---|
| PlaceboParticipants self-injected once-daily subcutaneous volume- and regimen-matched placebo for 26 weeks. | Drug | Placebo |
| CT-868Participants self-injected once-daily subcutaneous CT-868 for 26 weeks according to the randomized dose and regimen. | Drug | CT-868 1.75 mg, CT-868 4.0 mg |
Primary outcome
Change from Baseline in Glycated Hemoglobin A1c (HbA1c) at Week 26
Time frame: Baseline and Week 26
28 secondary outcomes
Change from Baseline in HbA1c at Week 12
Time frame: Baseline and Week 12
Percentage of Participants Achieving HbA1c <5.7% at Weeks 12 and 26
Time frame: Baseline and Weeks 12 and 26
Percentage of Participants Achieving HbA1c ≤6.5% at Weeks 12 and 26
Time frame: Baseline and Weeks 12 and 26
Percentage of Participants Achieving HbA1c <7.0% at Weeks 12 and 26
Time frame: Baseline and Weeks 12 and 26
Percent Change from Baseline in Body Weight at Weeks 12 and 26
Time frame: Baseline and Weeks 12 and 26
Absolute (kg) Change from Baseline in Body Weight at Weeks 12 and 26
Time frame: Baseline and Weeks 12 and 26
Percentage of Participants with ≥5% Body Weight Loss from Baseline at Weeks 12 and 26
Time frame: Baseline and Weeks 12 and 26
Percentage of Participants with ≥10% Body Weight Loss from Baseline at Weeks 12 and 26
Time frame: Baseline and Weeks 12 and 26
Percentage of Participants with ≥15% Body Weight Loss from Baseline at Weeks 12 and 26
Time frame: Baseline and Weeks 12 and 26
Percentage of Participants with ≥20% Body Weight Loss from Baseline at Weeks 12 and 26
Time frame: Baseline and Weeks 12 and 26
Change from Baseline in Fasting Plasma Glucose at Weeks 12 and 26
Time frame: Baseline and Weeks 12 and 26
Change from Baseline in Fasting Insulin at Weeks 12 and 26
Time frame: Baseline and Weeks 12 and 26
Change from Baseline in Waist Circumference at Weeks 12 and 26
Time frame: Baseline and Weeks 12 and 26
Change from Baseline in Hip Circumference at Weeks 12 and 26
Time frame: Baseline and Weeks 12 and 26
Change from Baseline in Waist-to-Hip Ratio at Weeks 12 and 26
Time frame: Baseline and Weeks 12 and 26
Change from Baseline in Waist-to-Height Ratio at Weeks 12 and 26
Time frame: Baseline and Weeks 12 and 26
Change from Baseline in Body Mass Index (BMI) at Weeks 12 and 26
Time frame: Baseline and Weeks 12 and 26
Change from Baseline in Total Cholesterol at Weeks 12 and 26
Time frame: Baseline and Weeks 12 and 26
Change from Baseline in Triglycerides at Weeks 12 and 26
Time frame: Baseline and Weeks 12 and 26
Change from Baseline in Low Density Lipoprotein (LDL) Cholesterol at Weeks 12 and 26
Time frame: Baseline and Weeks 12 and 26
Change from Baseline in High Density Lipoprotein (HDL) Cholesterol at Weeks 12 and 26
Time frame: Baseline and Weeks 12 and 26
Change from Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Weeks 12 and 26
Time frame: Baseline and Weeks 12 and 26
Change from Baseline in Apolipoprotein B at Weeks 12 and 26
Time frame: Baseline and Weeks 12 and 26
Change from Baseline in Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) at Weeks 12 and 26
Time frame: Baseline and Weeks 12 and 26
Change from Baseline in Quantitative Insulin Sensitivity Check Index (QUICKI) at Weeks 12 and 26
Time frame: Baseline and Weeks 12 and 26
Percentage of Participants with at Least One Treatment-Emergent Adverse Event
Time frame: From first dose of study drug until 4 weeks after the last dose of study drug (30 weeks)
Percentage of Participants with at Least One Hypoglycemic Event
Time frame: From first dose of study drug until 4 weeks after the last dose of study drug (30 weeks)
Percentage of Participants Testing Positive for Anti-Drug Antibodies to CT-868 at Baseline and Anytime Post-Baseline
Time frame: Baseline and Post-Baseline (up to 30 weeks)
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 Feb 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
5 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 CT-868 in people with Obesity and Overweight, run by Carmot Therapeutics, Inc. at 5 sites in Mexico.
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 4 inclusion and 3 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 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Mexico. 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?
Change from Baseline in Glycated Hemoglobin A1c (HbA1c) at Week 26 (time frame: Baseline and Week 26). 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 Feb 2026.