A Study of MSDC-0602K to Assess Glycemic Control and Cardiovascular Outcomes in Patients With Pre-T2D or T2D and NAFLD/NASH

NCT03970031 | Unknown Phase 3 DMC FDA Drug

• 1 other identifier: CTI-0602K-C013
• Study Type: interventional
• Target: 1,800
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Diabetes; NASH; NAFLD

Outcome Measures

Primary Outcomes (2)

• Change in glycosylated hemoglobin (HbA1c) from baseline to Week 26

  26 weeks

• Change in the weighted average of standardized AST, CK-18, and HbA1c values (standard deviations) from baseline to Week 26

  This is a single composite outcome measure. This is derived by standardizing the values of AST, CK-18, and HbA1c by subtracting the respective study population means and dividing by respective study population standard deviations at each time point; averaging these standardized AST, CK-18,and HbA1c values (or z-scores) for a given patient at each time point; and then computing the difference from baseline to week 26 with respect to these averages.

  26 weeks

Secondary Outcomes (2)

• Time to first event of death, adjudicated nonfatal MI or USA hospitalization, adjudicated hospital admission for HF, or adjudicated nonfatal ischemic stroke.

  through study completion, an expected average of 15 months

• Time to first event of death or adjudicated non-fatal MI or USA hospitalization, adjudicated hospital admission for HF, adjudicated nonfatal ischemic stroke, or liver event in all randomized subjects.

  through study completion, an expected average of 15 months

Study Arms (2)

MSDC-0602K

ACTIVE COMPARATOR

MSDC-0602K one tablet per day taken orally

Drug: MSDC-0602K

Placebo

PLACEBO COMPARATOR

Placebo one tablet per day taken orally

Drug: Placebo

Interventions

MSDC-0602K DRUG

MSDC-0602K tablet

MSDC-0602K

Placebo DRUG

Matching tablet

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent.
• Adult subjects with an age of \> 18 years but \< 80 years.
• Male or female subjects with reproductive potential must agree to comply with approved double barrier contraceptive method for the duration of the trial. Females of non-childbearing potential are considered:
• Post-menopausal Surgically sterile
• Diagnosis of NAFLD
• AST\>27 U/L
• HgbA1c \>6%
• Diagnosis of Pre-T2D or T2D
• History of macrovascular cardiovascular disease

You may not qualify if:

• Prior liver transplantation or currently on transplant list.
• Other well-documented causes of active chronic liver disease
• Current cirrhosis
• Pregnant or nursing women
• AST or ALT \> 5 times the upper limit of normal
• Total bilirubin \> 1.3 mg/dL unless diagnosis of Gilbert's disease with direct bilirubin within normal reference range
• Serum albumin \< 3.5 g/dL at Screening
• Alkaline phosphatase \>2 times the upper limit of normal at Screening
• Estimated glomerular filtration rate (eGFR by MDRD) \<30 ml/min/1.73 m2 but ≤75 ml/min/1.73 m2
• In patients who are not anticoagulated, INR ≥ 1.3 times ULN at Screening or other evidence of impaired coagulation.
• Acute vascular events including ACS, stroke or TIA, worsening of peripheral vascular disease or any vascular/cardiac procedure
• Limb amputation for reason other than trauma.
• HbA1c \>10%
• Any planned surgery or device implantation after screening
• Ejection fraction \< 35% or Heart failure with NYHA class IV

Sponsors & Collaborators

• Cirius Therapeutics, Inc.: lead

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: May 31, 2019
• Study Start: June 1, 2022
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: July 12, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share