OverviewStudy detailsEligibilityThings to knowResearchStudy plan
info
Simplify with AI

Phase 1 Study of CT-996 in Overweight/Obese Participants and Patients With Type 2 Diabetes Mellitus

PHASE1COMPLETED

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).

Study details:

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.

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  1. Participants 18-65 years old, inclusive
  2. BMI of 25 - 40, inclusive
  3. Stable body weight for two months
  4. Participants in Part 3 should have a documented diagnosis of Type 2 Diabetes Mellitus (T2DM)
  5. Participants in Part 3 should have glycated hemoglobin (HbA1c) between 7.0% and 10.0%

Exclusion criteria

  1. History of significant medical conditions and malignancy
  2. Uncontrollable hypertension
  3. History of alcoholism or drug addiction within 1 year prior to Screening
  4. Current or recent participation in an investigational clinical trial

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

study type

Study type

TREATMENT

phase

Phase

    PHASE1

trial

Study ID

NCT05814107

Intervention or treatment

DRUG: CT-996

DRUG: Placebo

Conditions

  • Type 2 Diabetes
  • Overweight or Obesity

  • Condition: Type 2 Diabetes, Overweight or Obesity

  • DRUG: CT-996 and other drugs

  • Melbourne, Australia

  • Sponsor: Carmot Australia First Pty Ltd

Save

Share

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial?

If you're a clinic or sponsor, you can claim this study

Research sites nearby

Closest Location:

Nucleus Network Pty Ltd.

Select from list below to view details:

  • Nucleus Network Pty Ltd.

    Melbourne, Australia

Loading map...

Who is running the clinical trial?

CAFPL

Carmot Australia First Pty Ltd

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Part 1: CT-996 SAD Cohort 1
  • Not Specified
Drug: CT-996
    EXPERIMENTAL: Part 1: CT-996 SAD Cohort 2
    • Not Specified
    Drug: CT-996
      EXPERIMENTAL: Part 1: CT-996 SAD Cohort 3, Then SAD Cohort 5
      • 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.
      Drug: CT-996
        EXPERIMENTAL: Part 1: CT-996 SAD Cohort 4
        • Not Specified
        Drug: CT-996
          EXPERIMENTAL: Part 1: CT-996 SAD Cohort 6
          • Not Specified
          Drug: CT-996
            PLACEBO_COMPARATOR: Part 1: Placebo SAD Cohort
            • Not Specified
            Drug: Placebo
              EXPERIMENTAL: Part 2: CT-996 MAD Cohort 1
              • Not Specified
              Drug: CT-996
                EXPERIMENTAL: Part 2: CT-996 MAD Cohort 2
                • Not Specified
                Drug: CT-996
                  EXPERIMENTAL: Part 2: CT-996 MAD Cohort 3
                  • Not Specified
                  Drug: CT-996
                    PLACEBO_COMPARATOR: Part 2: Placebo MAD Cohort
                    • Not Specified
                    Drug: Placebo
                      EXPERIMENTAL: Part 3: CT-996 MD T2DM Cohort 1
                      • Not Specified
                      Drug: CT-996
                        EXPERIMENTAL: Part 3: CT-996 MD T2DM Cohort 2
                        • Not Specified
                        Drug: CT-996
                          PLACEBO_COMPARATOR: Part 3: Placebo MD T2DM Cohort
                          • Not Specified
                          Drug: Placebo

                            What is the study measuring?

                            Primary Outcome

                            MeasureDescriptionTime Frame
                            Incidence of Treatment-Emergent Adverse EventsNot SpecifiedFrom first study drug administration until last safety follow-up (up to 31 days [Part 1] or 58 days [Parts 2 and 3])

                            Secondary Outcome

                            MeasureDescriptionTime Frame
                            Maximum Observed Plasma Concentration (Cmax) of CT-996Not SpecifiedAt 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-996Not SpecifiedAt 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-996Not SpecifiedAt 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-996Not SpecifiedAt 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-996Not SpecifiedAt prespecified timepoints from Day 1 to Day 5 (Part 1) or Day 33 (Parts 2 and 3)
                            Part 1 Cohorts: Clearance (CL) of CT-996Not SpecifiedAt prespecified timepoints from Day 1 to Day 5
                            Part 1 Cohorts: Volume of Distribution (V) of CT-996Not SpecifiedAt prespecified timepoints from Day 1 to Day 5
                            Part 2 Cohorts: Minimum Observed Plasma Concentration (Cmin) of CT-996Not SpecifiedAt prespecified timepoints from Day 1 to Day 33
                            Parts 2 and 3 Cohorts: Clearance Divided by the Bioavailable Fraction (CL/F) of CT-996Not SpecifiedAt 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-996Not SpecifiedAt 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-996Determine the effect of a high-fat meal on the PK of CT-996 following a single doseAt 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-996Determine the effect of a high-fat meal on the PK of CT-996 following a single doseAt prespecified timepoints for up to 14 days
                            Are you running this trial?If you're a clinic or sponsor, you can claim this study.
                            Claim this trial

                            References

                            Clinical Trials Gov: Phase 1 Study of CT-996 in Overweight/Obese Participants and Patients With Type 2 Diabetes Mellitus

                            Other trials to consider

                            Loading suggested trials...

                            Top searched conditions

                            Breast CancerLung CancerType 2 DiabetesDermatitisAlzheimersParkinsonsLupusCrohn’s DiseaseAsthmaHypertensionCOPDMultiple SclerosisOsteoarthritisHIV/AIDSPsoriasisStrokeObesityProstate CancerDepressionCardiovascular