Type 2 DiabetesPhase 1NCT05814107
Phase 1 Study of CT-996 in Overweight/Obese Participants and Patients With Type 2 Diabetes Mellitus
A Phase 1 study testing CT-996 in people with Type 2 Diabetes and Overweight or Obesity, run by Carmot Australia First Pty Ltd at 2 sites in 2 countries.
Trial summary
This study is designed to assess the safety and tolerability, pharmacokinetics, and pharmacodynamics of CT-996 in overweight/obese participants and participants with Type 2 Diabetes Mellitus (T2DM). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Overweight or Obesity
- What is being tested?
- CT-996
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 9 May 2023to 7 Nov 2025
- 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
- Participants 18-65 years old, inclusive
- BMI of 25 - 40, inclusive
- Stable body weight for two months
- Additional Inclusion Criterion for Part 3 (MD T2DM cohorts) only:
- Participants in Part 3 should have a documented diagnosis of Type 2 Diabetes Mellitus (T2DM)
- Participants in Part 3 should have glycated hemoglobin (HbA1c) between 7.0% and 10.0%
Who cannot join
- History of significant medical conditions and malignancy
- Uncontrollable hypertension
- History of alcoholism or drug addiction within 1 year prior to Screening
- Current or recent participation in an investigational clinical trial
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Mexico1 site
Avant Santé Research Center S.A. de C.V.
San Pedro Garza García, 66260
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of CT-996 in Overweight/Obese Participants and in Patients With Type 2 Diabetes Mellitus
This study is designed to assess the safety and tolerability, pharmacokinetics, and pharmacodynamics of CT-996 in overweight/obese participants and participants with Type 2 Diabetes Mellitus (T2DM).
Read the detailed description
This is a multi-center, randomized, double-blind, placebo-controlled, dose escalation, first in human study designed to assess the safety and tolerability, pharmacokinetics, and pharmacodynamics of CT-996 when administered as single ascending doses (SAD) and multiple-ascending doses (MAD) in overweight/obese participants and as multiple doses (MD) in patients with T2DM.
- Conditions
- Type 2 Diabetes, Overweight or Obesity
- Being tested
- CT-996, Placebo
- Keywords
- Type 2 Diabetes, Obesity, Overweight
- Medical subject headings
- Diabetes Mellitus, Type 2, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-996Drug
Also called RO7795081, RG6652
Capsule of CT-996
PlaceboDrug
Capsule of placebo matching CT-996.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: CT-996 SAD Cohort 1 | Experimental | Not described Receives: Drug: CT-996 |
| Part 1: CT-996 SAD Cohort 2 | Experimental | Not described Receives: Drug: CT-996 |
| Part 1: CT-996 SAD Cohort 3, Then SAD Cohort 5 | Experimental | During SAD Cohort 3, participants will be dosed under fasted conditions. During SAD Cohort 5, the same participants will receive the same dose under high-fat fed conditions. Receives: Drug: CT-996 |
| Part 1: CT-996 SAD Cohort 4 | Experimental | Not described Receives: Drug: CT-996 |
| Part 1: CT-996 SAD Cohort 6 | Experimental | Not described Receives: Drug: CT-996 |
| Part 1: Placebo SAD Cohort | Placebo comparator | Not described Receives: Drug: Placebo |
| Part 2: CT-996 MAD Cohort 1 | Experimental | Not described Receives: Drug: CT-996 |
| Part 2: CT-996 MAD Cohort 2 | Experimental | Not described Receives: Drug: CT-996 |
| Part 2: CT-996 MAD Cohort 3 | Experimental | Not described Receives: Drug: CT-996 |
| Part 2: Placebo MAD Cohort | Placebo comparator | Not described Receives: Drug: Placebo |
| Part 3: CT-996 MD T2DM Cohort 1 | Experimental | Not described Receives: Drug: CT-996 |
| Part 3: CT-996 MD T2DM Cohort 2 | Experimental | Not described Receives: Drug: CT-996 |
| Part 3: Placebo MD T2DM Cohort | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
Measured: From first study drug administration until last safety follow-up (up to 31 days [Part 1] or 58 days [Parts 2 and 3])
Secondary outcomes (12)
Maximum Observed Plasma Concentration (Cmax) of CT-996
Measured: At prespecified timepoints from Day 1 to Day 5 (Part 1) or Day 33 (Parts 2 and 3)
Time to Maximum Observed Plasma Concentration (Tmax) of CT-996
Measured: At prespecified timepoints from Day 1 to Day 5 (Part 1) or Day 33 (Parts 2 and 3)
Area Under the Concentration-Time Curve (AUC) from Time 0 to the Time of Last Measurable Concentration (AUC0-t) of CT-996
Measured: At prespecified timepoints from Day 1 to Day 5 (Part 1) or Day 33 (Parts 2 and 3)
AUC from Time 0 Extrapolated to Infinity (AUC0-inf) of CT-996
Measured: At prespecified timepoints from Day 1 to Day 5 (Part 1) or Day 33 (Parts 2 and 3)
Apparent Terminal Elimination Half-Life (t1/2) of CT-996
Measured: At prespecified timepoints from Day 1 to Day 5 (Part 1) or Day 33 (Parts 2 and 3)
Part 1 Cohorts: Clearance (CL) of CT-996
Measured: At prespecified timepoints from Day 1 to Day 5
Part 1 Cohorts: Volume of Distribution (V) of CT-996
Measured: At prespecified timepoints from Day 1 to Day 5
Part 2 Cohorts: Minimum Observed Plasma Concentration (Cmin) of CT-996
Measured: At prespecified timepoints from Day 1 to Day 33
Parts 2 and 3 Cohorts: Clearance Divided by the Bioavailable Fraction (CL/F) of CT-996
Measured: At prespecified timepoints from Day 1 to Day 33
Parts 2 and 3 Cohorts: Volume of Distribution Divided by the Bioavailable Fraction (Vz/F) of CT-996
Measured: At prespecified timepoints from Day 1 to Day 33
Part 1 SAD Cohorts 3 and 5: Food Effect of a High-Fat Meal on Cmax of CT-996
Determine the effect of a high-fat meal on the PK of CT-996 following a single dose
Measured: At prespecified timepoints for up to 14 days
Part 1 SAD Cohorts 3 and 5: Food Effect of a High-Fat Meal on AUC of CT-996
Determine the effect of a high-fat meal on the PK of CT-996 following a single dose
Measured: At prespecified timepoints for up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start9 May 2023
- Primary completion7 Nov 2025
- Study completion7 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carmot Australia First Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Carmot Therapeutics, Inc., 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
- NCT05814107
- Sponsor's protocol ID
- CT-996-201
- Status last verified
- Nov 2025
- First submitted
- 23 Feb 2023
- Last updated
- 28 Nov 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 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of CT-996 in Overweight/Obese Participants and in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05814107
- Acronym / sponsor ID
- CT-996-201
- Conditions
- Type 2 Diabetes, Overweight or Obesity
- Keywords
- Type 2 Diabetes, Obesity, Overweight
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Carmot Australia First Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- Carmot Therapeutics, Inc., Hoffmann-La Roche
- Study start
- 9 May 2023 (actual)
- Primary completion
- 7 Nov 2025 (actual)
- Study completion
- 7 Nov 2025 (actual)
- First posted
- 14 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 is designed to assess the safety and tolerability, pharmacokinetics, and pharmacodynamics of CT-996 in overweight/obese participants and participants with Type 2 Diabetes Mellitus (T2DM).
Detailed description
This is a multi-center, randomized, double-blind, placebo-controlled, dose escalation, first in human study designed to assess the safety and tolerability, pharmacokinetics, and pharmacodynamics of CT-996 when administered as single ascending doses (SAD) and multiple-ascending doses (MAD) in overweight/obese participants and as multiple doses (MD) in patients with T2DM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 13
| Arm | Type | Receives |
|---|---|---|
| Part 1: CT-996 SAD Cohort 1 | Experimental | Drug: CT-996 |
| Part 1: CT-996 SAD Cohort 2 | Experimental | Drug: CT-996 |
| Part 1: CT-996 SAD Cohort 3, Then SAD Cohort 5 | Experimental | Drug: CT-996During SAD Cohort 3, participants will be dosed under fasted conditions. During SAD Cohort 5, the same participants will receive the same dose under high-fat fed conditions. |
| Part 1: CT-996 SAD Cohort 4 | Experimental | Drug: CT-996 |
| Part 1: CT-996 SAD Cohort 6 | Experimental | Drug: CT-996 |
| Part 1: Placebo SAD Cohort | Placebo comparator | Drug: Placebo |
| Part 2: CT-996 MAD Cohort 1 | Experimental | Drug: CT-996 |
| Part 2: CT-996 MAD Cohort 2 | Experimental | Drug: CT-996 |
| Part 2: CT-996 MAD Cohort 3 | Experimental | Drug: CT-996 |
| Part 2: Placebo MAD Cohort | Placebo comparator | Drug: Placebo |
| Part 3: CT-996 MD T2DM Cohort 1 | Experimental | Drug: CT-996 |
| Part 3: CT-996 MD T2DM Cohort 2 | Experimental | Drug: CT-996 |
| Part 3: Placebo MD T2DM Cohort | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants 18-65 years old, inclusive
- BMI of 25 - 40, inclusive
- Stable body weight for two months
- Participants in Part 3 should have a documented diagnosis of Type 2 Diabetes Mellitus (T2DM)
- Participants in Part 3 should have glycated hemoglobin (HbA1c) between 7.0% and 10.0%
Key exclusion criteria (4 listed)
- History of significant medical conditions and malignancy
- Uncontrollable hypertension
- History of alcoholism or drug addiction within 1 year prior to Screening
- Current or recent participation in an investigational clinical trial
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-996Also: RO7795081, RG6652Capsule of CT-996 | Drug | Part 1: CT-996 SAD Cohort 1, Part 1: CT-996 SAD Cohort 2, Part 1: CT-996 SAD Cohort 3, Then SAD Cohort 5, Part 1: CT-996 SAD Cohort 4, Part 1: CT-996 SAD Cohort 6, Part 2: CT-996 MAD Cohort 1, Part 2: CT-996 MAD Cohort 2, Part 2: CT-996 MAD Cohort 3, Part 3: CT-996 MD T2DM Cohort 1, Part 3: CT-996 MD T2DM Cohort 2 |
| PlaceboCapsule of placebo matching CT-996. | Drug | Part 1: Placebo SAD Cohort, Part 2: Placebo MAD Cohort, Part 3: Placebo MD T2DM Cohort |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: From first study drug administration until last safety follow-up (up to 31 days [Part 1] or 58 days [Parts 2 and 3])
12 secondary outcomes
Maximum Observed Plasma Concentration (Cmax) of CT-996
Time frame: At prespecified timepoints from Day 1 to Day 5 (Part 1) or Day 33 (Parts 2 and 3)
Time to Maximum Observed Plasma Concentration (Tmax) of CT-996
Time frame: At prespecified timepoints from Day 1 to Day 5 (Part 1) or Day 33 (Parts 2 and 3)
Area Under the Concentration-Time Curve (AUC) from Time 0 to the Time of Last Measurable Concentration (AUC0-t) of CT-996
Time frame: At prespecified timepoints from Day 1 to Day 5 (Part 1) or Day 33 (Parts 2 and 3)
AUC from Time 0 Extrapolated to Infinity (AUC0-inf) of CT-996
Time frame: At prespecified timepoints from Day 1 to Day 5 (Part 1) or Day 33 (Parts 2 and 3)
Apparent Terminal Elimination Half-Life (t1/2) of CT-996
Time frame: At prespecified timepoints from Day 1 to Day 5 (Part 1) or Day 33 (Parts 2 and 3)
Part 1 Cohorts: Clearance (CL) of CT-996
Time frame: At prespecified timepoints from Day 1 to Day 5
Part 1 Cohorts: Volume of Distribution (V) of CT-996
Time frame: At prespecified timepoints from Day 1 to Day 5
Part 2 Cohorts: Minimum Observed Plasma Concentration (Cmin) of CT-996
Time frame: At prespecified timepoints from Day 1 to Day 33
Parts 2 and 3 Cohorts: Clearance Divided by the Bioavailable Fraction (CL/F) of CT-996
Time frame: At prespecified timepoints from Day 1 to Day 33
Parts 2 and 3 Cohorts: Volume of Distribution Divided by the Bioavailable Fraction (Vz/F) of CT-996
Time frame: At prespecified timepoints from Day 1 to Day 33
Part 1 SAD Cohorts 3 and 5: Food Effect of a High-Fat Meal on Cmax of CT-996
Time frame: At prespecified timepoints for up to 14 days
Part 1 SAD Cohorts 3 and 5: Food Effect of a High-Fat Meal on AUC of CT-996
Time frame: At prespecified timepoints for up to 14 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 Nov 2025.
- 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
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-996 in people with Type 2 Diabetes and Overweight or Obesity, run by Carmot Australia First Pty Ltd 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 6 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 28 Nov 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 (time frame: From first study drug administration until last safety follow-up (up to 31 days [Part 1] or 58 days [Parts 2 and 3])). 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 Nov 2025.