Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Carmot Therapeutics, Inc. | INDUSTRY |
| Hoffmann-La Roche | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: CT-996 SAD Cohort 1 | Experimental |
| |
| Part 1: CT-996 SAD Cohort 2 | Experimental |
| |
| 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. |
|
| Part 1: CT-996 SAD Cohort 4 | Experimental |
| |
| Part 1: CT-996 SAD Cohort 6 | Experimental |
| |
| Part 1: Placebo SAD Cohort | Placebo Comparator |
| |
| Part 2: CT-996 MAD Cohort 1 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT-996 | Drug | Capsule of CT-996 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | From first study drug administration until last safety follow-up (up to 31 days [Part 1] or 58 days [Parts 2 and 3]) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of CT-996 | 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 | At prespecified timepoints from Day 1 to Day 5 (Part 1) or Day 33 (Parts 2 and 3) |
Not provided
Inclusion Criteria:
Additional Inclusion Criterion for Part 3 (MD T2DM cohorts) only:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Carmot Therapeutics, Inc., a Member of the Roche Group | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nucleus Network Pty Ltd. | Melbourne | 3004 | Australia | |||
| Avant Santé Research Center S.A. de C.V. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Part 2: CT-996 MAD Cohort 2 | Experimental |
|
| Part 2: CT-996 MAD Cohort 3 | Experimental |
|
| Part 2: Placebo MAD Cohort | Placebo Comparator |
|
| Part 3: CT-996 MD T2DM Cohort 1 | Experimental |
|
| Part 3: CT-996 MD T2DM Cohort 2 | Experimental |
|
| Part 3: Placebo MD T2DM Cohort | Placebo Comparator |
|
|
| Placebo | Drug | Capsule of placebo matching CT-996. |
|
| Area Under the Concentration-Time Curve (AUC) from Time 0 to the Time of Last Measurable Concentration (AUC0-t) of CT-996 | 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 | 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 | 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 | At prespecified timepoints from Day 1 to Day 5 |
| Part 1 Cohorts: Volume of Distribution (V) of CT-996 | At prespecified timepoints from Day 1 to Day 5 |
| Part 2 Cohorts: Minimum Observed Plasma Concentration (Cmin) of CT-996 | 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 | 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 | 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 | 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 | At prespecified timepoints for up to 14 days |
| San Pedro Garza GarcĂa |
| 66260 |
| Mexico |
| D004700 | Endocrine System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |