DiabetesPhase 1NCT04973111
A Study to Assess CT-868 and the Relationship Between Insulin Secretory Response and Ambient Blood Glucose
A Phase 1 study testing CT-868 as SC Injection and Active Comparator as SC Injection in people with Diabetes, run by Carmot Therapeutics, Inc. at 1 site in United States.
Trial summary
A Study to Assess the Effect of CT-868 and the Relationship Between Insulin Secretory Response and Ambient Blood Glucose in Obese Male Subjects and Subjects with T2DM. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- CT-868 as SC Injection and Active Comparator as SC Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2021to 22 Apr 2022
- Phase
- Phase 1
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Part 1: Obese Otherwise Healthy Males
- Part 2: Males or Females with T2D
- Part 1: BMI 30.0-35.0, inclusive
- Part 2: BMI 27.0-45.0, inclusive
- 18-65 years old, inclusive
- Stable body weight for 2 months
Who cannot join
- Significant medical history
- Uncontrolled hypertension
- History of malignancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Carmot Clinical Research Unit 101
Chula Vista, California, 91911
About this study
Official title: A Randomized, Double-Blind, Placebo and Comparator-Controlled Crossover Study to Assess Pharmacokinetic and Pharmacodynamic Effects of CT-868 on the Relationship Between Insulin Secretory Response and Ambient Blood Glucose in Obese Male Subjects and Subjects with T2DM
A Study to Assess the Effect of CT-868 and the Relationship Between Insulin Secretory Response and Ambient Blood Glucose in Obese Male Subjects and Subjects with T2DM.
- Conditions
- Diabetes
- Being tested
- CT-868 as SC Injection, Placebo as SC Injection, Active Comparator as SC Injection
- Keywords
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Overweight, Metabolic Diseases, Body Weight
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Overweight, Metabolic Diseases, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-868 as SC InjectionDrug
CT-868
Placebo as SC InjectionDrug
Placebo
Active Comparator as SC InjectionDrug
Active Comparator
| Study group | Role | What they receive |
|---|---|---|
| CT-868 | Experimental | SC dose of CT-868 Intervention: Drug: CT-868 Receives: Drug: CT-868 as SC Injection |
| Placebo | Placebo comparator | SC dose of placebo matching CT-868 dose Intervention: Drug: Placebo Receives: Drug: Placebo as SC Injection |
| Active Comparator | Active comparator | SC dose of Active Comparator Intervention: Drug: Active Comparator Receives: Drug: Active Comparator as SC Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in insulin secretion rate and ambient glucose levels
Measured: Baseline up to 4 days
Secondary outcomes (2)
Change in blood insulin levels at each level of glucose infusion
Measured: Baseline up to 4 days
Change in blood glucose levels at each level of glucose infusion
Measured: Baseline up to 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start16 Jul 2021
- Primary completion22 Apr 2022
- Study completion22 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 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
- NCT04973111
- Sponsor's protocol ID
- CT-868-003
- Status last verified
- Mar 2025
- First submitted
- 14 Jul 2021
- Last updated
- 28 Mar 2025
- 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 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo and Comparator-Controlled Crossover Study to Assess Pharmacokinetic and Pharmacodynamic Effects of CT-868 on the Relationship Between Insulin Secretory Response and Ambient Blood Glucose in Obese Male Subjects and Subjects with T2DM
- ClinicalTrials.gov ID
- NCT04973111
- Acronym / sponsor ID
- CT-868-003
- Conditions
- Diabetes
- Keywords
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Overweight, Metabolic Diseases, Body Weight
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Carmot Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Jul 2021 (actual)
- Primary completion
- 22 Apr 2022 (actual)
- Study completion
- 22 Apr 2022 (actual)
- First posted
- 22 Jul 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 and the Relationship Between Insulin Secretory Response and Ambient Blood Glucose in Obese Male Subjects and Subjects with T2DM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CT-868 | Experimental | Drug: CT-868 as SC InjectionSC dose of CT-868 Intervention: Drug: CT-868 |
| Placebo | Placebo comparator | Drug: Placebo as SC InjectionSC dose of placebo matching CT-868 dose Intervention: Drug: Placebo |
| Active Comparator | Active comparator | Drug: Active Comparator as SC InjectionSC dose of Active Comparator Intervention: Drug: Active Comparator |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Part 1: Obese Otherwise Healthy Males
- Part 2: Males or Females with T2D
- Part 1: BMI 30.0-35.0, inclusive
- Part 2: BMI 27.0-45.0, inclusive
- 18-65 years old, inclusive
Key exclusion criteria (3 listed)
- Significant medical history
- Uncontrolled hypertension
- 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 |
|---|---|---|
| CT-868 as SC InjectionCT-868 | Drug | CT-868 |
| Placebo as SC InjectionPlacebo | Drug | Placebo |
| Active Comparator as SC InjectionActive Comparator | Drug | Active Comparator |
Primary outcome
Change in insulin secretion rate and ambient glucose levels
Time frame: Baseline up to 4 days
2 secondary outcomes
Change in blood insulin levels at each level of glucose infusion
Time frame: Baseline up to 4 days
Change in blood glucose levels at each level of glucose infusion
Time frame: Baseline up to 4 days
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 Mar 2025.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CT-868 as SC Injection and Active Comparator as SC Injection in people with Diabetes, run by Carmot Therapeutics, Inc. at 1 site 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 6 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 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 in insulin secretion rate and ambient glucose levels (time frame: Baseline up to 4 days). 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 Mar 2025; AzTrials last refreshed its copy on 30 Oct 2026.