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

A study designed to assess the safety and tolerability, pharmacokinetics, and pharmacodynamics of CT-996 in overweight/obese participants and participants with T2DM.

Full description

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 and multiple-ascending doses in overweight/obese participants and as multiple doses in patients with T2DM.

Enrollment: 118 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

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: Triple Blind

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118 participants in 2 patient groups, including a placebo group

CT-996

Experimental group

Description:

Capsule of CT-996 intervention

Treatment:

Drug: CT-996

Placebo

Placebo Comparator group

Description:

Capsule of placebo matching CT-996 dose

Treatment:

Drug: Placebo