OverweightPhase 2NCT06062069
A Study of CT-868 in Type 1 Diabetes Mellitus
A Phase 2 study testing CT-868 and CT-868 Pen Injector in people with Overweight and Obese, run by Carmot Therapeutics, Inc. at 22 sites in United States.
Trial summary
This study will evaluate the changes in glycemic control in overweight and obese adults with Type 1 Diabetes Mellitus after receiving CT-868 for 16 weeks. The effectiveness and safety of CT-868 will be compared to placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overweight, Obese, Type 1 Diabetes Mellitus
- What is being tested?
- CT-868 and CT-868 Pen Injector
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 111 participants
- Where
- 22 sitesUnited States
- Study dates
- 27 Nov 2023to 7 Jul 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, 18 years of age or older at the time of signing informed consent
- Have a documented clinical diagnosis of T1DM greater than or equal to 1 year before the Screening Visit
- Body mass index greater than or equal to27.0 kg/m2
- Hemoglobin A1c (HbA1c) level between 7.0% and 10.0%, inclusive, at the Screening Visit
Who cannot join
- Diagnosis of Type 2 diabetes mellitus (T2DM) or any other types of diabetes, except T1DM
- Experienced diabetic ketoacidosis (DKA) within 3 months prior to the Screening Visit
- Experienced severe hypoglycemia (Level 3 as defined in the ADA Standards of Medical Care in Diabetes (ADA 2022) within 3 months prior to the Screening Visit
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
University of North Carolina Health Sciences at MAHEC
Asheville, North Carolina, 28803
Atlanta Diabetes Associates
Atlanta, Georgia, 30309
University of Colorado - Barbara Davis Center for Diabetes
Aurora, Colorado, 80045
Texas Diabetes and Endocrinology, P.A
Austin, Texas, 78731
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27517
John Muir Physician Network Clinical Research Center
Concord, California, 94520
Velocity Clinical Research - Dallas
Dallas, Texas, 75230
Research Institute of Dallas
Dallas, Texas, 75231
Denver Endocrinology Diabetes and Thyroid Center
Englewood, Colorado, 80113
Headlands Research- AMCR
Escondido, California, 92025
MedStar Health Research Institute - Washington Hospital Center
Hyattsville, Maryland, 20782
Rocky Mountain Clinical Research, LLC- Idaho Falls, Idaho
Idaho Falls, Idaho, 83404
Lucas Research, Inc
Morehead City, North Carolina, 28557
Advent Health
Orlando, Florida, 32804
Orlando Health Science Clinic, LLC
Orlando, Florida, 32822
Innovative Research Institute
Port Charlotte, Florida, 33952
Oregon Health and Science University
Portland, Oregon, 97239
Rainier Clinical Research Center
Renton, Washington, 98057
Diabetes & Glandular Disease Clinic, P.A.
San Antonio, Texas, 78229
Consano Clinical Research
Shavano Park, Texas, 78231
Texas Valley Clinical Research, LLC
Weslaco, Texas, 78596
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, 50266
About this study
Official title: A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of CT-868 Administered for 16 Weeks to Overweight and Obese Adult Participants With Type 1 Diabetes Mellitus
This study will evaluate the changes in glycemic control in overweight and obese adults with Type 1 Diabetes Mellitus after receiving CT-868 for 16 weeks. The effectiveness and safety of CT-868 will be compared to placebo. All participants will continue with their standard diabetes care using either an insulin pump (CSII) or multiple daily injections (MDI). Alongside their designated treatment, participants will receive guidance on managing their diabetes, including monitoring blood glucose levels and diet and exercise recommendations. Treatment assignments, either CT-868 plus insulin or placebo plus insulin will be randomly determined.
- Conditions
- Overweight, Obese, Type 1 Diabetes Mellitus
- Being tested
- CT-868, CT-868 Pen Injector, CT-868 Pen Injector, Placebo
- Medical subject headings
- Overweight, Obesity, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-868Drug
Also called Acmopatide, RO7795074
CT-868 is an investigational medication administered subcutaneously via a pre-filled pen injector device.
CT-868 Pen InjectorDevice
The CT-868 pen injector is a multi-dose, single-participant, disposable pen.
CT-868 Pen Injector, PlaceboDrug
The placebo pen injector is identical and contains the same ingredients except for CT-868.
| Study group | Role | What they receive |
|---|---|---|
| CT-868 Low Dose | Experimental | Participants in this arm will receive the drug CT-868 in a subcutaneous injection form. The dosage is set at up to 1.8 mg, and it will be administered once daily for a total duration of 16 weeks. Receives: Drug: CT-868; Device: CT-868 Pen Injector |
| CT-868 Medium Dose | Experimental | Participants in this arm will receive the drug CT-868 in a subcutaneous injection form. The dosage is set at up to 4.1 mg, and it will be administered once daily for a total duration of 16 weeks. Receives: Drug: CT-868; Device: CT-868 Pen Injector |
| CT-868 High Dose | Experimental | Participants in this arm will receive the drug CT-868 in a subcutaneous injection form. The dosage is set at up to 6.6 mg, and it will be administered once daily for a total duration of 16 weeks. Receives: Drug: CT-868; Device: CT-868 Pen Injector |
| CT-868 Placebo | Placebo comparator | Participants in this arm will receive a placebo designed to match the appearance and formulation of the drug CT-868. The intervention consists of a subcutaneous injection of this placebo. The placebo will be administered once daily for a duration of 16 weeks. Receives: Device: CT-868 Pen Injector; Drug: CT-868 Pen Injector, Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Glycated Hemoglobin (HbA1c) (%) at Week 16
Baseline was defined as the last available non-missing value prior to the first dose of the randomized study drug. The analysis was based on the mixed-effect model of repeated measures (MMRM).
Measured: Baseline (Day 1) to Week 16
Secondary outcomes (43)
Percent Change From Baseline in Body Weight at Week 16
Baseline was defined as the last available non-missing value prior to the first dose of the randomized study drug. The analysis was based on the MMRM.
Measured: Baseline (Day 1) to Week 16
Change From Baseline in HbA1c (%) at Weeks 4, 8, and 12
Baseline was defined as the last available non-missing value prior to the first dose of the randomized study drug. The analysis was based on the MMRM.
Measured: Baseline (Day 1) to Weeks 4, 8, and 12
Percentage of Participants Achieving HbA1c Target of <7.0% at Week 16
Percentages have been rounded off.
Measured: At Week 16
Percentage of Participants Achieving HbA1c Target of ≤6.5% at Week 16
Percentages have been rounded off.
Measured: At Week 16
Percentage of Participants Achieving HbA1c Target of <5.7% at Week 16
Measured: At Week 16
Change From Baseline in Total Daily Insulin Dose at Weeks 8 and 16
Baseline was defined as the median daily insulin dose (units per day [units/day]) over a consecutive 7-day period prior to Day 1, provided that at least 4 of those 7 days had non-missing daily insulin dose data. If no such 7-day period existed within the 14-day placebo run-in period, the baseline was considered missing. The same algorithm was used for calculating values for Week 8 and 16. Total daily insulin dose was only calculated when daily bolus and daily basal are both present.
Measured: Baseline (Day 1), Weeks 8 and 16
Change From Baseline in Basal Insulin Dose at Weeks 8 and 16
Baseline was defined as the median daily insulin dose (units/day) over a consecutive 7-day period prior to Day 1, provided that at least 4 of those 7 days had non-missing daily insulin dose data. If no such 7-day period existed within the 14-day placebo run-in period, the baseline was considered missing. The same algorithm was used for calculating values for Week 8 and 16.
Measured: Baseline (Day 1), Weeks 8 and 16
Change From Baseline in Bolus Insulin Dose at Weeks 8 and 16
Baseline was defined as the median daily insulin dose (units/day) over a consecutive 7-day period prior to Day 1, provided that at least 4 of those 7 days had non-missing daily insulin dose data. If no such 7-day period existed within the 14-day placebo run-in period, the baseline was considered missing. The same algorithm was used for calculating values for Week 8 and 16.
Measured: Baseline (Day 1), Weeks 8 and 16
Percent Change From Baseline in Total Daily Insulin Dose at Weeks 8 and 16
Baseline total daily insulin dose was defined as the median daily insulin dose over 7 days within a 14 consecutive days period prior to Day 1, provided that at least 4 out of those 7 days had non-missing daily insulin dose data. The similar algorithm applies to Week 8 and 16. The analysis was based on the MMRM.
Measured: Baseline (Day 1), Weeks 8 and 16
Percent Change From Baseline in Basal Insulin Dose at Weeks 8 and 16
Baseline basal insulin dose was defined as the median daily insulin dose over 7 days within a 14 consecutive days period prior to Day 1, provided that at least 4 out of those 7 days had non-missing daily insulin dose data. The similar algorithm applies to Week 8 and 16. The analysis was based on the MMRM.
Measured: Baseline (Day 1), Weeks 8 and 16
Percent Change From Baseline in Bolus Insulin Dose at Weeks 8 and 16
Baseline bolus insulin dose was defined as the median daily insulin dose over 7 days within a 14 consecutive days period prior to Day 1, provided that at least 4 out of those 7 days had non-missing daily insulin dose data. The similar algorithm applies to Week 8 and 16. The analysis was based on the MMRM.
Measured: Baseline (Day 1), Weeks 8 and 16
Percent Change From Baseline in Body Weight-adjusted Total Daily Insulin Dose at Weeks 8 and 16
Baseline total daily insulin dose was defined as the median daily insulin dose over 7 days within a 14 consecutive days period prior to Day 1, provided that at least 4 out of those 7 days had non-missing daily insulin dose data. The similar algorithm applies to Week 8 and 16. The analysis was based on the MMRM. units/kg/day=units per kilograms per day.
Measured: Baseline (Day 1), Weeks 8 and 16
Percent Change From Baseline in Body Weight-adjusted Basal Insulin Dose at Weeks 8 and 16
Baseline basal insulin dose was defined as the median daily insulin dose over 7 days within a 14 consecutive days period prior to Day 1, provided that at least 4 out of those 7 days had non-missing daily insulin dose data. The similar algorithm applies to Week 8 and 16. The analysis was based on the MMRM.
Measured: Baseline (Day 1), Weeks 8 and 16
Percent Change From Baseline in Body Weight-adjusted Bolus Insulin Dose at Weeks 8 and 16
Baseline of bolus insulin dose was defined as the median daily insulin dose over 7 days within a 14 consecutive days period prior to Day 1, provided that at least 4 out of those 7 days had non-missing daily insulin dose data. The similar algorithm applies to Week 8 and 16. The analysis was based on the MMRM.
Measured: Baseline (Day 1), Weeks 8 and 16
Change From Baseline in Continuous Glucose Monitoring (CGM) Intraday Mean Sensor Glucose
All participants used a CGM device for glucose monitoring throughout the treatment. The change was assessed as: Change = Baseline CGM parameter value + HbA1c strata (< 8.5% or ≥ 8.5%) + Methods of insulin administration (pump or multiple daily injection [MDI]) + Week + Treatment + Treatment*Week (repeated values over Week 8 and 16). The analysis was based on the MMRM.
Measured: Baseline (Day 1), Weeks 8 and 16
Change From Baseline in CGM Interday Mean Sensor Glucose
All participants used a CGM device for glucose monitoring throughout the treatment. The change was assessed as: Change = Baseline CGM parameter value + HbA1c strata (<8.5% or ≥8.5%) + Methods of insulin administration (pump or MDI) + Week + Treatment + Treatment*Week (repeated values over Week 8 and 16). The analysis was based on the MMRM.
Measured: Baseline (Day 1), Weeks 8 and 16
Change From Baseline in Percentage of Time Spent in Range (TIR) 70-180 mg/dL
All participants used a CGM device for glucose monitoring throughout the treatment. TIR represents the percentage of time a participant's glucose levels stay within a target range of 70-180 mg/dL. The change was assessed as: Change = Baseline CGM parameter value + HbA1c strata (<8.5% or ≥8.5%) + Methods of insulin administration (pump or MDI) + Week + Treatment + Treatment*Week (repeated values over Week 8 and 16). The analysis was based on the MMRM.
Measured: Baseline (Day 1), Weeks 8 and 16
Change From Baseline in Percentage of TIR 70-140 mg/dL
All participants used a CGM device for glucose monitoring throughout the treatment. TIR represents the percentage of time a participant's glucose levels stay within a target range of 70-140 mg/dL. The change was assessed as: Change = Baseline CGM parameter value + HbA1c strata (<8.5% or ≥8.5%) + Methods of insulin administration (pump or MDI) + Week + Treatment + Treatment*Week (repeated values over Week 8 and 16). The analysis was based on the MMRM.
Measured: Baseline (Day 1), Weeks 8 and 16
Change From Baseline in CGM Percent Time Spent in Level 1 Hypoglycemia (Time Below Target Range [TBTR, <54-70 mg/dL]) and Level 2 Hypoglycemia (Time Very Below Target Range [TVBTR <54 mg/dL])
All participants used a CGM device for glucose monitoring throughout the treatment. TIR represents the percentage of time a participant's glucose levels stay below the target range of <54-70 mg/dL and very below the target range of <54 mg/dL. The change was assessed as: Change = Baseline CGM parameter value + HbA1c strata (<8.5% or ≥8.5%) + Methods of insulin administration (pump or MDI) + Week + Treatment + Treatment*Week (repeated values over Week 8 and 16). The analysis was based on the MMRM.
Measured: Baseline (Day 1), Weeks 8 and 16
Change From Baseline in CGM Percent Time Spent in Level 1 Hyperglycemia (Time Above Target Range [TATR, >180-250 mg/dL]) and Level 2 Hyperglycemia (Time Very Above Target Range [TVATR >250 mg/dL])
All participants used a CGM device for glucose monitoring throughout the treatment. TIR represents the percentage of time a participant's glucose levels stay TATR >180-250 mg/dL and TVATR >250 mg/dL. The change was assessed as: Change = Baseline CGM parameter value + HbA1c strata (<8.5% or ≥8.5%) + Methods of insulin administration (pump or MDI) + Week + Treatment + Treatment*Week (repeated values over Week 8 and 16). The analysis was based on the MMRM.
Measured: Baseline (Day 1), Weeks 8 and 16
Event Rate With Sensor Glucose <70 mg/dL Lasting at Least 120 Minutes
All participants used a CGM device for glucose monitoring throughout the treatment. Data is reported for event rate (number of events per person-year). Number of events with sensor glucose <70 mg/dL lasting at least 120 minutes and without gaps >30 minutes between consecutive CGM readings (event ends when glucose returns to ≥70 mg/dL for ≥15 minutes) was assessed. Percentages have been rounded off.
Measured: Weeks 8 and 16
Event Rate With Sensor Glucose >250 mg/dL Lasting at Least 120 Minutes
All participants used a CGM device for glucose monitoring throughout the treatment. Data are reported for event rates. Event=sensor glucose >250 mg/dL lasting at least 120 minutes and without gaps >30 minutes between consecutive CGM readings (event ends when glucose returns to ≤180 mg/dL for ≥15 minutes). Percentages have been rounded off.
Measured: Weeks 8 and 16
Number of Participants With TIR 70-180 mg/dL With ≥5% Points Improvement From Baseline
All participants used a CGM device for glucose monitoring throughout the treatment. TIR represents the percentage of time a participant's glucose levels stay within a target range of 70-180 mg/dL.
Measured: At Weeks 8 and 16
Number of Participants With TIR 70-180 mg/dL With ≥10% Points Improvement From Baseline
All participants used a CGM device for glucose monitoring throughout the treatment. TIR represents the percentage of time a participant's glucose levels stay within a target range of 70-180 mg/dL.
Measured: At Weeks 8 and 16
Number of Participants With TIR 70-180 mg/dL for >70% of the 14-day Collection Interval Around the Week 8 Visit and the 14-day Interval Prior to the Week 16 Visit
All participants used a CGM device for glucose monitoring throughout the treatment. TIR represents the percentage of time a participant's glucose levels stay within a target range of 70-180 mg/dL.
Measured: At Weeks 8 and 16
Number of Participants With Time Below Range (TBR) <70 mg/dL for <4% of Each Day
All participants used a CGM device for glucose monitoring throughout the treatment.
Measured: Baseline, Weeks 8 and 16
Number of Participants With TBR <54 mg/dL for <1% of Each Day
All participants used a CGM device for glucose monitoring throughout the treatment.
Measured: Baseline, Weeks 8 and 16
Number of Participants With Time Above Range (TAR) >180 mg/dL for <25% of Each Day
All participants used a CGM device for glucose monitoring throughout the treatment.
Measured: Baseline, Weeks 8 and 16
Number of Participants With TAR >250 mg/dL for <5% of Each Day
All participants used a CGM device for glucose monitoring throughout the treatment.
Measured: Baseline, Weeks 8 and 16
Number of Participants With TBR <70 mg/dL for <4% Over the 14-day Collection Window
All participants used a CGM device for glucose monitoring throughout the treatment.
Measured: Baseline, Weeks 8 and 16
Number of Participants With TBR <54 mg/dL for <1% Over the 14-day Collection Window
All participants used a CGM device for glucose monitoring throughout the treatment.
Measured: Baseline, Weeks 8 and 16
Number of Participants With TAR >180 mg/dL for <25% Over the 14-day Collection Window
All participants used a CGM device for glucose monitoring throughout the treatment.
Measured: Baseline, Weeks 8 and 16
Number of Participants With TAR >250 mg/dL for <5% Over the 14-day Collection Window
All participants used a CGM device for glucose monitoring throughout the treatment.
Measured: Baseline, Weeks 8 and 16
Percent Change From Baseline in the Glycemic Risk Index
All participants used a CGM device for glucose monitoring throughout the treatment.
Measured: Baseline, Weeks 8 and 16
Percent Change From Baseline in Body Weight at Day 1 to Weeks 4, 8, 12, and 16
Measured: Baseline (Day 1), and Weeks 4, 8, 12, and 16
Absolute Change From Baseline in Body Weight at Day 1 to Weeks 4, 8, 12, and 16
Measured: Baseline (Day 1), and Weeks 4, 8, 12, and 16
Percentage of Participants Achieving ≥5%, ≥10%, ≥15%, and ≥20% Weight Loss at Week 16
Measured: At Week 16
Percentage of Participants Experiencing 1 or More Level 1, 2, or 3 Hypoglycemia Events (Worst Severity)
Level 1 hypoglycemia: glucose between <70-54 mg/dL; Level 2 hypoglycemia: glucose level between <54 mg/dL; Level 3 hypoglycemia: These episodes may be associated with sufficient neuroglycopenia to induce seizure or coma.
Measured: Postbaseline from Day 1 to Week 16
Event Rate of Level 2 Hypoglycemia Over the 2-Week Baseline Period and the 16-Week Treatment Period
The baseline period event rate was calculated as (the total number of events) / (14/365.25 * number of patients). Baseline hypoglycemia events occurred within 14 days prior to first treatment start time (Day 1). The treatment period event rate was calculated as (the total number of events) / (sum of the person-time exposed to the study drug after randomization (in years)). Sum of the person-time exposed to the study drug after randomization is calculated as the time from first to last dose of study drug for all participants in the respective treatment arm.
Measured: Baseline Period (14 days before Day 1) and Treatment Period (up to 16 weeks)
Number of Participants With Diabetic Ketoacidosis (DKA) Events
DKA episode was defined as the presence of acidosis (blood pH <7.3, serum bicarbonate levels <18 milliequivalents per liter [mEq/L]), and accompanied by symptoms/signs per the anti-drug antibody (ADA) consensus statement on diagnosis of DKA or if the DKA episode results in a hospital or emergency room stay.
Measured: Up to Week 18
Participants With DKA Events That Led to Hospitalization or Emergency Room Visits During the Study
DKA episode was defined as the presence of acidosis (blood pH <7.3, serum bicarbonate levels <18 mEq/L), and accompanied by symptoms/signs per the ADA consensus statement on diagnosis of DKA or if the DKA episode results in a hospital or emergency room stay.
Measured: Up to Week 18
Number of Participants With Adverse Events (AEs) and Adverse Device Effects (ADEs) Over the Period of 16 Weeks
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An ADE was defined as an AE related to the medical device; in this study, the medical device is the pen device with which the study drug is administered. This included any event that was the result of incomplete user manual information or of incorrect use of the medical device.
Measured: Up to 16 weeks
Plasma Drug Concentrations of CT-868 at the Weeks 2, 4, 6, 8, 12, and 16 Visits
Measured: At 24 hours post-dose on Weeks 2, 4, 6, 8, 12, and 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start27 Nov 2023
- Primary completion7 Jul 2025
- Study completion7 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OverweightStudies 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
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carmot Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Carmot Therapeutics, Inc., a member of the Roche Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06062069
- Sponsor's protocol ID
- CT-868-004
- Status last verified
- Oct 2026
- First submitted
- 14 Sep 2023
- Last updated
- 28 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of CT-868 Administered for 16 Weeks to Overweight and Obese Adult Participants With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06062069
- Acronym / sponsor ID
- CT-868-004
- Conditions
- Overweight, Obese, Type 1 Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Carmot Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 7 Jul 2025 (actual)
- Study completion
- 7 Jul 2025 (actual)
- First posted
- 2 Oct 2023 (actual)
- Results
- Posted 28 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the changes in glycemic control in overweight and obese adults with Type 1 Diabetes Mellitus after receiving CT-868 for 16 weeks. The effectiveness and safety of CT-868 will be compared to placebo. All participants will continue with their standard diabetes care using either an insulin pump (CSII) or multiple daily injections (MDI). Alongside their designated treatment, participants will receive guidance on managing their diabetes, including monitoring blood glucose levels and diet and exercise recommendations. Treatment assignments, either CT-868 plus insulin or placebo plus insulin will be randomly determined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CT-868 Low Dose | Experimental | Drug: CT-868, Device: CT-868 Pen InjectorParticipants in this arm will receive the drug CT-868 in a subcutaneous injection form. The dosage is set at up to 1.8 mg, and it will be administered once daily for a total duration of 16 weeks. |
| CT-868 Medium Dose | Experimental | Drug: CT-868, Device: CT-868 Pen InjectorParticipants in this arm will receive the drug CT-868 in a subcutaneous injection form. The dosage is set at up to 4.1 mg, and it will be administered once daily for a total duration of 16 weeks. |
| CT-868 High Dose | Experimental | Drug: CT-868, Device: CT-868 Pen InjectorParticipants in this arm will receive the drug CT-868 in a subcutaneous injection form. The dosage is set at up to 6.6 mg, and it will be administered once daily for a total duration of 16 weeks. |
| CT-868 Placebo | Placebo comparator | Device: CT-868 Pen Injector, Drug: CT-868 Pen Injector, PlaceboParticipants in this arm will receive a placebo designed to match the appearance and formulation of the drug CT-868. The intervention consists of a subcutaneous injection of this placebo. The placebo will be administered once daily for a duration of 16 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female, 18 years of age or older at the time of signing informed consent
- Have a documented clinical diagnosis of T1DM greater than or equal to 1 year before the Screening Visit
- Body mass index greater than or equal to27.0 kg/m2
- Hemoglobin A1c (HbA1c) level between 7.0% and 10.0%, inclusive, at the Screening Visit
Key exclusion criteria (3 listed)
- Diagnosis of Type 2 diabetes mellitus (T2DM) or any other types of diabetes, except T1DM
- Experienced diabetic ketoacidosis (DKA) within 3 months prior to the Screening Visit
- Experienced severe hypoglycemia (Level 3 as defined in the ADA Standards of Medical Care in Diabetes (ADA 2022) within 3 months prior to the Screening Visit
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 |
|---|---|---|
| CT-868Also: Acmopatide, RO7795074CT-868 is an investigational medication administered subcutaneously via a pre-filled pen injector device. | Drug | CT-868 High Dose, CT-868 Low Dose, CT-868 Medium Dose |
| CT-868 Pen InjectorThe CT-868 pen injector is a multi-dose, single-participant, disposable pen. | Device | CT-868 High Dose, CT-868 Low Dose, CT-868 Medium Dose, CT-868 Placebo |
| CT-868 Pen Injector, PlaceboThe placebo pen injector is identical and contains the same ingredients except for CT-868. | Drug | CT-868 Placebo |
Primary outcome
Change From Baseline in Glycated Hemoglobin (HbA1c) (%) at Week 16
Time frame: Baseline (Day 1) to Week 16
Baseline was defined as the last available non-missing value prior to the first dose of the randomized study drug. The analysis was based on the mixed-effect model of repeated measures (MMRM).
43 secondary outcomes
Percent Change From Baseline in Body Weight at Week 16
Time frame: Baseline (Day 1) to Week 16
Change From Baseline in HbA1c (%) at Weeks 4, 8, and 12
Time frame: Baseline (Day 1) to Weeks 4, 8, and 12
Percentage of Participants Achieving HbA1c Target of <7.0% at Week 16
Time frame: At Week 16
Percentage of Participants Achieving HbA1c Target of ≤6.5% at Week 16
Time frame: At Week 16
Percentage of Participants Achieving HbA1c Target of <5.7% at Week 16
Time frame: At Week 16
Change From Baseline in Total Daily Insulin Dose at Weeks 8 and 16
Time frame: Baseline (Day 1), Weeks 8 and 16
Change From Baseline in Basal Insulin Dose at Weeks 8 and 16
Time frame: Baseline (Day 1), Weeks 8 and 16
Change From Baseline in Bolus Insulin Dose at Weeks 8 and 16
Time frame: Baseline (Day 1), Weeks 8 and 16
Percent Change From Baseline in Total Daily Insulin Dose at Weeks 8 and 16
Time frame: Baseline (Day 1), Weeks 8 and 16
Percent Change From Baseline in Basal Insulin Dose at Weeks 8 and 16
Time frame: Baseline (Day 1), Weeks 8 and 16
Percent Change From Baseline in Bolus Insulin Dose at Weeks 8 and 16
Time frame: Baseline (Day 1), Weeks 8 and 16
Percent Change From Baseline in Body Weight-adjusted Total Daily Insulin Dose at Weeks 8 and 16
Time frame: Baseline (Day 1), Weeks 8 and 16
Percent Change From Baseline in Body Weight-adjusted Basal Insulin Dose at Weeks 8 and 16
Time frame: Baseline (Day 1), Weeks 8 and 16
Percent Change From Baseline in Body Weight-adjusted Bolus Insulin Dose at Weeks 8 and 16
Time frame: Baseline (Day 1), Weeks 8 and 16
Change From Baseline in Continuous Glucose Monitoring (CGM) Intraday Mean Sensor Glucose
Time frame: Baseline (Day 1), Weeks 8 and 16
Change From Baseline in CGM Interday Mean Sensor Glucose
Time frame: Baseline (Day 1), Weeks 8 and 16
Change From Baseline in Percentage of Time Spent in Range (TIR) 70-180 mg/dL
Time frame: Baseline (Day 1), Weeks 8 and 16
Change From Baseline in Percentage of TIR 70-140 mg/dL
Time frame: Baseline (Day 1), Weeks 8 and 16
Change From Baseline in CGM Percent Time Spent in Level 1 Hypoglycemia (Time Below Target Range [TBTR, <54-70 mg/dL]) and Level 2 Hypoglycemia (Time Very Below Target Range [TVBTR <54 mg/dL])
Time frame: Baseline (Day 1), Weeks 8 and 16
Change From Baseline in CGM Percent Time Spent in Level 1 Hyperglycemia (Time Above Target Range [TATR, >180-250 mg/dL]) and Level 2 Hyperglycemia (Time Very Above Target Range [TVATR >250 mg/dL])
Time frame: Baseline (Day 1), Weeks 8 and 16
Event Rate With Sensor Glucose <70 mg/dL Lasting at Least 120 Minutes
Time frame: Weeks 8 and 16
Event Rate With Sensor Glucose >250 mg/dL Lasting at Least 120 Minutes
Time frame: Weeks 8 and 16
Number of Participants With TIR 70-180 mg/dL With ≥5% Points Improvement From Baseline
Time frame: At Weeks 8 and 16
Number of Participants With TIR 70-180 mg/dL With ≥10% Points Improvement From Baseline
Time frame: At Weeks 8 and 16
Number of Participants With TIR 70-180 mg/dL for >70% of the 14-day Collection Interval Around the Week 8 Visit and the 14-day Interval Prior to the Week 16 Visit
Time frame: At Weeks 8 and 16
Number of Participants With Time Below Range (TBR) <70 mg/dL for <4% of Each Day
Time frame: Baseline, Weeks 8 and 16
Number of Participants With TBR <54 mg/dL for <1% of Each Day
Time frame: Baseline, Weeks 8 and 16
Number of Participants With Time Above Range (TAR) >180 mg/dL for <25% of Each Day
Time frame: Baseline, Weeks 8 and 16
Number of Participants With TAR >250 mg/dL for <5% of Each Day
Time frame: Baseline, Weeks 8 and 16
Number of Participants With TBR <70 mg/dL for <4% Over the 14-day Collection Window
Time frame: Baseline, Weeks 8 and 16
Number of Participants With TBR <54 mg/dL for <1% Over the 14-day Collection Window
Time frame: Baseline, Weeks 8 and 16
Number of Participants With TAR >180 mg/dL for <25% Over the 14-day Collection Window
Time frame: Baseline, Weeks 8 and 16
Number of Participants With TAR >250 mg/dL for <5% Over the 14-day Collection Window
Time frame: Baseline, Weeks 8 and 16
Percent Change From Baseline in the Glycemic Risk Index
Time frame: Baseline, Weeks 8 and 16
Percent Change From Baseline in Body Weight at Day 1 to Weeks 4, 8, 12, and 16
Time frame: Baseline (Day 1), and Weeks 4, 8, 12, and 16
Absolute Change From Baseline in Body Weight at Day 1 to Weeks 4, 8, 12, and 16
Time frame: Baseline (Day 1), and Weeks 4, 8, 12, and 16
Percentage of Participants Achieving ≥5%, ≥10%, ≥15%, and ≥20% Weight Loss at Week 16
Time frame: At Week 16
Percentage of Participants Experiencing 1 or More Level 1, 2, or 3 Hypoglycemia Events (Worst Severity)
Time frame: Postbaseline from Day 1 to Week 16
Event Rate of Level 2 Hypoglycemia Over the 2-Week Baseline Period and the 16-Week Treatment Period
Time frame: Baseline Period (14 days before Day 1) and Treatment Period (up to 16 weeks)
Number of Participants With Diabetic Ketoacidosis (DKA) Events
Time frame: Up to Week 18
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- 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
22 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 and CT-868 Pen Injector in people with Overweight and Obese, run by Carmot Therapeutics, Inc. at 22 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 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 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 22 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?
Yes. Results are posted in the registry (first posted 28 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (HbA1c) (%) at Week 16 (time frame: Baseline (Day 1) to Week 16). 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.