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

Carmot Therapeutics0 个研究点目标入组 87 人开始时间: 2018年12月12日最近更新: 2020年4月27日

适应症

试验速览

暂无简介。

•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

•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

发起方

Carmot Therapeutics