Trials Sponsors Conditions Drugs Pricing

Conditions

Overweight or Obesity Type 2 Diabetes

Keywords

Type 2 DiabetesObesityOverweight

Outcome Measures

Primary Outcomes (1)

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])

Secondary Outcomes (12)

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)
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)
+7 more secondary outcomes

Study Arms (13)

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

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

Interventions

CT-996Drug

Capsule of CT-996

Also known as: RO7795081, RG6652

Part 1: CT-996 SAD Cohort 1Part 1: CT-996 SAD Cohort 2Part 1: CT-996 SAD Cohort 3, Then SAD Cohort 5Part 1: CT-996 SAD Cohort 4Part 1: CT-996 SAD Cohort 6Part 2: CT-996 MAD Cohort 1Part 2: CT-996 MAD Cohort 2Part 2: CT-996 MAD Cohort 3Part 3: CT-996 MD T2DM Cohort 1

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Participants 18-65 years old, inclusive
BMI of 25 - 40, inclusive

Sponsors & Collaborators

Carmot Australia First Pty Ltd
Industrylead
Carmot Therapeutics, Inc.
Industrycollaborator
Hoffmann-La Roche

Study Sites (2)

Nucleus Network Pty Ltd.

Melbourne, 3004, Australia

Avant Santé Research Center S.A. de C.V.

San Pedro Garza García, 66260, Mexico

MeSH Terms

Conditions

Diabetes Mellitus, Type 2OverweightObesity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

Clinical Trials
Carmot Therapeutics, Inc., a Member of the Roche Group
STUDY DIRECTOR

Enrollment

94 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: SEQUENTIAL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 23, 2023

First Posted

April 14, 2023

Study Start

May 9, 2023

Actual (reported)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (12)

Study Arms (13)

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

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Part 1: CT-996 SAD Cohort 4

Part 1: CT-996 SAD Cohort 6

Part 1: Placebo SAD Cohort

Part 2: CT-996 MAD Cohort 1

Part 2: CT-996 MAD Cohort 2

Part 2: CT-996 MAD Cohort 3

Part 2: Placebo MAD Cohort

Part 3: CT-996 MD T2DM Cohort 1

Part 3: CT-996 MD T2DM Cohort 2

Part 3: Placebo MD T2DM Cohort

You may not qualify if:

Data Sharing

Source record

Locations