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

Carmot Australia First

Status and phase: Enrolling; Phase 1

Conditions: Overweight or Obesity; Type 2 Diabetes

Treatments: Drug: Placebo; Drug: CT-996

Study type: Interventional

Funder types: Industry

Identifiers

NCT05814107

CT-996-201

Details and patient eligibility

About

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).

Full 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.

Enrollment: 94 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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%

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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94 participants in 13 patient groups, including a placebo group

Part 1: CT-996 SAD Cohort 1

Experimental group

Treatment:

Drug: CT-996

Part 1: CT-996 SAD Cohort 2

Experimental group

Treatment:

Drug: CT-996

Part 1: CT-996 SAD Cohort 3, Then SAD Cohort 5

Experimental group

Description:

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.

Treatment:

Drug: CT-996

Part 1: CT-996 SAD Cohort 4

Experimental group

Treatment:

Drug: CT-996

Part 1: CT-996 SAD Cohort 6

Experimental group

Treatment:

Drug: CT-996

Part 1: Placebo SAD Cohort

Placebo Comparator group

Treatment:

Drug: Placebo

Part 2: CT-996 MAD Cohort 1

Experimental group

Treatment:

Drug: CT-996

Part 2: CT-996 MAD Cohort 2

Experimental group

Treatment:

Drug: CT-996

Part 2: CT-996 MAD Cohort 3

Experimental group

Treatment:

Drug: CT-996

Part 2: Placebo MAD Cohort

Placebo Comparator group

Treatment:

Drug: Placebo

Part 3: CT-996 MD T2DM Cohort 1

Experimental group

Treatment:

Drug: CT-996

Part 3: CT-996 MD T2DM Cohort 2

Experimental group

Treatment:

Drug: CT-996

Part 3: Placebo MD T2DM Cohort

Placebo Comparator group

Treatment:

Drug: Placebo