Type 1 DiabetesPhase 1NCT05794581
A Study to Assess the Effects of CT-868 Treatment on Glucose Homeostasis in Participants with Type 1 Diabetes
A Phase 1 study testing CT-868 and Victoza in people with Type 1 Diabetes, run by Carmot Therapeutics, Inc. at 1 site in United States.
Trial summary
This study will be conducted primarily to evaluate the effects of CT-868 on glucose homeostasis in participants with Type 1 Diabetes Mellitus. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- CT-868 and Victoza
- 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
- 21 Mar 2023to 6 Apr 2024
- 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
- Female or male adults with Type 1 diabetes
- Ages 18-65 years
- Type 1 DM for at least 3 years
- Using an insulin pump or multiple daily injections (MDI) for at least 3 months
- BMI 25.0 - 35.0
Who cannot join
- Significant medical history
- Uncontrolled diabetes
- History of surgical treatment for weight loss
- 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 the Effects of CT-868 Treatment on Glucose Homeostasis in Participants with Type 1 Diabetes
This study will be conducted primarily to evaluate the effects of CT-868 on glucose homeostasis in participants with Type 1 Diabetes Mellitus.
- Conditions
- Type 1 Diabetes
- Being tested
- CT-868, Placebo, Victoza
- Keywords
- Type 1 Diabetes, Obesity, Overweight
- Medical subject headings
- Diabetes Mellitus, Type 1, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-868Drug
CT-868
PlaceboDrug
Placebo as SC Injection
VictozaDrug
Also called Liraglutide
Victoza as active comparator as SC Injection
| Study group | Role | What they receive |
|---|---|---|
| CT-868 | Experimental | SC injection of CT-868 Intervention Receives: Drug: CT-868 |
| Placebo | Placebo comparator | SC injection of placebo matching CT-868 dose Receives: Drug: Placebo |
| Victoza | Active comparator | SC injection of active comparator Receives: Drug: Victoza |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess area under the curve (AUC) in glucose metabolism during MMTT
Measured: Baseline up to 4 days
Secondary outcomes (2)
To assess changes in continuous glucose monitoring (CGM) measures
Measured: Baseline up to 4 days
Area under the acetaminophen concentration-time (AUC)
Measured: 0 - 300 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start21 Mar 2023
- Primary completion6 Mar 2024
- Study completion6 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05794581
- Sponsor's protocol ID
- CT-868-005
- Status last verified
- Dec 2024
- First submitted
- 10 Mar 2023
- Last updated
- 27 Dec 2024
- 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 27 Dec 2024. 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 the Effects of CT-868 Treatment on Glucose Homeostasis in Participants with Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT05794581
- Acronym / sponsor ID
- CT-868-005
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 Diabetes, Obesity, Overweight
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Carmot Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- 6 Mar 2024 (actual)
- Study completion
- 6 Apr 2024 (actual)
- First posted
- 3 Apr 2023 (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 study will be conducted primarily to evaluate the effects of CT-868 on glucose homeostasis in participants with Type 1 Diabetes Mellitus.
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-868SC injection of CT-868 Intervention |
| Placebo | Placebo comparator | Drug: PlaceboSC injection of placebo matching CT-868 dose |
| Victoza | Active comparator | Drug: VictozaSC injection of active comparator |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female or male adults with Type 1 diabetes
- Ages 18-65 years
- Type 1 DM for at least 3 years
- Using an insulin pump or multiple daily injections (MDI) for at least 3 months
- BMI 25.0 - 35.0
Key exclusion criteria (4 listed)
- Significant medical history
- Uncontrolled diabetes
- History of surgical treatment for weight loss
- 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-868CT-868 | Drug | CT-868 |
| PlaceboPlacebo as SC Injection | Drug | Placebo |
| VictozaAlso: LiraglutideVictoza as active comparator as SC Injection | Drug | Victoza |
Primary outcome
To assess area under the curve (AUC) in glucose metabolism during MMTT
Time frame: Baseline up to 4 days
2 secondary outcomes
To assess changes in continuous glucose monitoring (CGM) measures
Time frame: Baseline up to 4 days
Area under the acetaminophen concentration-time (AUC)
Time frame: 0 - 300 minutes
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 27 Dec 2024.
- Carmot Therapeutics, Inc.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Type 1 Diabetes
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Victoza in people with Type 1 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 5 inclusion and 4 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 27 Dec 2024. 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?
To assess area under the curve (AUC) in glucose metabolism during MMTT (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 27 Dec 2024.