A Double-Blind, Randomized, Placebo-Controlled Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of CT-868 in Healthy Overweight/Obese Participants and in Patients withType 2 Diabetes Mellitus

Phase 1

• Conditions: Obese; Type 2 Diabetes Mellitus; Diet and Nutrition - Obesity; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12618001988246
• Lead Sponsor: Carmot Therapeutics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-12-12
• Study Completion: 2019-11-22
• Last Update Posted: 27 April 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 87

Inclusion Criteria

All study parts:
• Males and females aged 18-65 years (inclusive)
• Body mass index (BMI) 27-45 kg/m2
• No more than 5% weight loss within the preceding 3 months
• Normal blood pressure or well managed hypertension
• Females must be non-pregnant and non-lactating, and either surgically sterile
• Males must be surgically sterile, abstinent, or if engaged in sexual relations with a WOCBP, the participant and his partner must be surgically sterile or using an acceptable, highly effective contraceptive method from screening until study completion,
Part 1 only:
• Certified as healthy by comprehensive clinical assessment
Part 1 and 2:
• Fasting plasma glucose less than or equal to 100 mg/dL (6.0 mmol/L)
Part 2 and 3 only:
• Waist circumference greater than or equal to 102 cm (males) or greater than or equal to 88 cm (females)
Part 3 only:
• Confirmed diagnosis of T2DM
• If not antidiabetic medication naïve, participants must be on a stable dose metformin or a DPP-4 inhibitor or a combination of these for at least 3 months prior to study enrollment
• Fasting insulin greater than 10 uIU/mL (> 60pmol/L)
• HbA1c equal to or greater than 7.0% and equal to but not greater than 10.0%
• Non-Alcoholic Fatty Liver Disease (NAFLD) as defined by an MRI-PDFF with greater to or equal to 10% steatosis
• Normal lipid profile or well managed dyslipidemia

Exclusion Criteria

• Pregnant or lactating, or intending to become pregnant within 30 days after last dose of study drug
• Participation in a clinical trial within 30 days before randomization; use of any experimental therapy within 30 days or 5 half-lives prior to randomization, whichever is greater; or use of any biologic therapy within 12 weeks or 5 half-lives prior to randomization, whichever is greater. Participants who have received an experimental therapy that has no half-life, like a vaccine, should have completed that therapy at least 12 weeks prior to randomization
• Any non-experimental vaccine within 12 weeks of randomization, until 4 weeks after the last dose, except for seasonal influenza vaccination which is permitted
• Use of any weight loss agent within 12 weeks prior to screening
• Surgery or hospitalization during the 4 weeks prior to screening
• Within the last 2 years, unstable or clinically significant cardiovascular disease
Part 3 only:
• Use of glitazones, sulfonylureas, or injectables (glucagon-like peptide 1 [GLP-1] mimetics, insulin) in the 3 months prior to study enrollment
• Persistent hyperglycemia, defined as a glucose level >270 mg/dL, not controlled by a stable dose of an a-glucosidase inhibitor or metformin or a DPP-4 inhibitor or a combination of these and/or diet/exercise
• A diagnosis of clinically significant diabetic neuropathy, retinopathy, nephropathy or renal impairment

Study & Design

• Study Type: Interventional
• Study Design: Not specified