DiabetesPhase 1NCT04838405
A Study of CT-388 in Otherwise Healthy Overweight and Obese Adults and Patients With Type 2 Diabetes Mellitus
A Phase 1 study testing CT-388 in people with Diabetes, run by Carmot Therapeutics, Inc. at 2 sites in 2 countries.
Trial summary
This is a first-in-human evaluation of CT-388 in a double blind, placebo controlled, randomized, SAD/MAD/MD, safety, tolerance, PK, and PD study when administered as a SC injection in otherwise healthy overweight and obese adult participants and obese participants 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-388
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 129 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 29 Apr 2021to 2 Aug 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
- Males or females
- 18-65 years old, inclusive
- BMI 27.0-40.0, inclusive
- Stable body weight for 2 months
Who cannot join
- Significant medical history
- Uncontrolled hypertension
- History of malignancy
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Australia1 site
Carmot Clinical Research Unit 101
Perth, Western Australia, 6009
About this study
Official title: A Phase 1 Randomized, Double Blind, Placebo Controlled, Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CT-388 in Otherwise Healthy Overweight and Obese Adult Participants and in Obese Patients With Type 2 Diabetes Mellitus
This is a first-in-human evaluation of CT-388 in a double blind, placebo controlled, randomized, SAD/MAD/MD, safety, tolerance, PK, and PD study when administered as a SC injection in otherwise healthy overweight and obese adult participants and obese participants with T2DM.
- Conditions
- Diabetes
- Being tested
- CT-388, Placebo
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-388Drug
Synthetic Peptide
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| CT-388 | Experimental | SC dose of CT-388 Receives: Drug: CT-388 |
| Placebo | Placebo comparator | SC dose of placebo matching CT-388 dose Receives: Drug: Placebo |
| CT-388 Optional | Experimental | SC dose of CT-388 Receives: Drug: CT-388 |
| CT-388 MD | Experimental | SC dose of CT-388 Receives: Drug: CT-388 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events as assessed by self-report
Safety and tolerability
Measured: Baseline up to 24 weeks
Secondary outcomes (6)
Area under the concentration versus time curve (AUC)
PK AUC
Measured: Baseline up to 24 weeks
Maximum observed drug concentration (Cmax)
PK Cmax
Measured: Baseline up to 24 weeks
Elimination half-life
PK t1/2
Measured: Baseline up to 24 weeks
Change in mean body weight
PD body weight
Measured: Baseline up to 24 weeks
Change in mean glucose levels
PD glucose
Measured: Baseline up to 24 weeks
Change in mean insulin levels
PD insulin
Measured: Baseline up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start29 Apr 2021
- Primary completion18 Jun 2024
- Study completion2 Aug 2024
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
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carmot Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Carmot Australia First Pty Ltd
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Carmot Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04838405
- Sponsor's protocol ID
- CT-388-101
- Status last verified
- Oct 2025
- First submitted
- 5 Apr 2021
- Last updated
- 20 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized, Double Blind, Placebo Controlled, Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CT-388 in Otherwise Healthy Overweight and Obese Adult Participants and in Obese Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04838405
- Acronym / sponsor ID
- CT-388-101
- Conditions
- Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Carmot Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Carmot Australia First Pty Ltd
- Study start
- 29 Apr 2021 (actual)
- Primary completion
- 18 Jun 2024 (actual)
- Study completion
- 2 Aug 2024 (actual)
- First posted
- 9 Apr 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.
This is a first-in-human evaluation of CT-388 in a double blind, placebo controlled, randomized, SAD/MAD/MD, safety, tolerance, PK, and PD study when administered as a SC injection in otherwise healthy overweight and obese adult participants and obese participants with T2DM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CT-388 | Experimental | Drug: CT-388SC dose of CT-388 |
| Placebo | Placebo comparator | Drug: PlaceboSC dose of placebo matching CT-388 dose |
| CT-388 Optional | Experimental | Drug: CT-388SC dose of CT-388 |
| CT-388 MD | Experimental | Drug: CT-388SC dose of CT-388 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males or females
- 18-65 years old, inclusive
- BMI 27.0-40.0, inclusive
- Stable body weight for 2 months
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-388Synthetic Peptide | Drug | CT-388, CT-388 MD, CT-388 Optional |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Incidence of Treatment-Emergent Adverse Events as assessed by self-report
Time frame: Baseline up to 24 weeks
Safety and tolerability
6 secondary outcomes
Area under the concentration versus time curve (AUC)
Time frame: Baseline up to 24 weeks
Maximum observed drug concentration (Cmax)
Time frame: Baseline up to 24 weeks
Elimination half-life
Time frame: Baseline up to 24 weeks
Change in mean body weight
Time frame: Baseline up to 24 weeks
Change in mean glucose levels
Time frame: Baseline up to 24 weeks
Change in mean insulin levels
Time frame: Baseline up to 24 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 20 Oct 2025.
- Carmot Therapeutics, Inc.Link 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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CT-388 in people with Diabetes, run by Carmot Therapeutics, Inc. at 2 sites in 2 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 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 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia, 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 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?
Incidence of Treatment-Emergent Adverse Events as assessed by self-report (time frame: Baseline up to 24 weeks). 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 20 Oct 2025.