A Study of MSDC-0602K to Assess Glycemic Control and Cardiovascular Outcomes in Patients With Pre-T2D or T2D and NAFLD/NASH
NCT03970031 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1800
Last updated 2021-07-12
Summary
This is a randomized, double-blind study of MSDC-0602K or placebo in subjects with pre-T2D or T2D and evidence of NAFLD/NASH.
Conditions
- Type2 Diabetes
- NASH - Nonalcoholic Steatohepatitis
- Nonalcoholic Steatohepatitis
- Non-Alcoholic Fatty Liver Disease
Interventions
- DRUG
-
MSDC-0602K
MSDC-0602K tablet
- DRUG
-
Matching tablet
Sponsors & Collaborators
-
Cirius Therapeutics, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-06-30
- Primary Completion
- 2024-09-30
- Completion
- 2024-09-30
- FDA Drug
- Yes
More Related Trials
-
Study of the Safety and Efficacy of MK-8521 Compared to Placebo and a Diabetes Drug in Participants With Type 2 Diabetes Mellitus (MK-8521-003)
NCT01982630 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Evaluate Safety, Tolerability, Pharmacokinetics & Pharmacodynamics of JTT-662 in Subjects With Type 2 Diabetes
NCT04465877 ·Status: COMPLETED ·Phase: PHASE1
-
Randomized, Placebo-controlled, 2 Period, Single-blind, Sequential, Multiple Ascending Dose Study
NCT01956305 ·Status: COMPLETED ·Phase: PHASE1
-
Placebo-controlled, Proof-of-concept Study to Evaluate the Safety and Efficacy of Lanifibranor Alone and in Combination With SGLT2 Inhibitor EmpaGliflozin in patiEnts With NASH and Type 2 Diabetes Mellitus
NCT05232071 ·Status: COMPLETED ·Phase: PHASE2
-
A Single and Multiple-Dose Study of MK-8521 in Healthy and Obese Males (MK-8521-002)
NCT02055547 ·Status: COMPLETED ·Phase: PHASE1
-
A Study In Patients With Type 2 Diabetes Mellitus
NCT00256867 ·Status: COMPLETED ·Phase: PHASE3
-
A Study in Healthy Male Volunteers to Investigate Different Doses of a New Drug for the Treatment of Metabolic Diseases
NCT01340911 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) Assessment of LIK066 in Healthy Subjects and in Patients With Type 2 Diabetes Mellitus (T2DM)
NCT01407003 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A 16 Week Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With Type 2 Diabetes Mellitus
NCT03985293 ·Status: COMPLETED ·Phase: PHASE2
-
A First Human Dose Study Investigating Safety and Concentration of Study Medicine in the Blood Following Once Daily Oral Dosing of NNC0560-0004 in Healthy Adults.
NCT06133270 ·Status: COMPLETED ·Phase: PHASE1
-
A Multiple Ascending Dose Study to Evaluate Safety and Tolerability of BFKB8488A in Participants With Type 2 Diabetes Mellitus and Participants With Non-Alcoholic Fatty Liver Disease
NCT03060538 ·Status: COMPLETED ·Phase: PHASE1
-
Food Effect, Efficacy and Safety of MKP10241 in Healthy and Obese Adult Participants, With and Without Diabetes
NCT07098663 ·Status: RECRUITING ·Phase: PHASE2
-
A Study to Assess the Effect of Food on HR20033 and Pharmacokinetic After Multiple Dose in Healthy Volunteers
NCT05120219 ·Status: UNKNOWN ·Phase: PHASE1
-
A Multicenter, Randomized, Open-Label, Parallel-Controlled Clinical Study Comparing the Efficacy and Safety of Cofrogliptin Versus Acarbose in Drug-Naïve Patients With Type 2 Diabetes
NCT07122102 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
A Study to Evaluate and Study Drug Levels in Blood Plasma When Giving High Doses of GSK189075 to Healthy Volunteers
NCT00501930 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of LC542019 in Healthy Subjects and Subjects With T2DM
NCT06333977 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Efficacy and Safety of CJ-30001 and CJ-30002 in Type 2 Diabetes Mellitus Patients
NCT01370707 ·Status: COMPLETED ·Phase: PHASE3
-
MK-1006 Single Dose Study in Japanese Type 2 Diabetes Patients (MK-1006-005)
NCT00791661 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Test the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK1006 (MK-1006-002)(COMPLETED)
NCT00757601 ·Status: COMPLETED ·Phase: PHASE1
-
Phase II Dose-Finding Study of SK-0403 With Type 2 Diabetes Mellitus
NCT00532506 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-06882961 in Japanese Adults With Type 2 Diabetes Mellitus
NCT04552470 ·Status: COMPLETED ·Phase: PHASE1
-
Clinical Study to Assess the Pharmacokinetics, Safety and Tolerability of SRT2104 Administered to Normal Healthy Male Volunteers
NCT00933062 ·Status: COMPLETED ·Phase: PHASE1
-
Metformin and Vascular Function in Prediabetes
NCT06526494 ·Status: WITHDRAWN ·Phase: PHASE2
-
A Clinical Study to Evaluate the Pharmacokinetics and the Absolute Bioavailability of SRT2104 Given as a 250mg Oral Suspension and Intravenous Microdose of 100 µg Carbon-14 Radio-labeled SRT2104 in Healthy Male Subjects
NCT00937872 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase 1 Single/Multiple Dose Study Of PF-06293620 To Assess Safety, Tolerability And Pharmacokinetics In Subjects With Type 2 Diabetes Mellitus
NCT02211261 ·Status: COMPLETED ·Phase: PHASE1