Type2 DiabetesPhase 3NCT03970031
A Study of MSDC-0602K to Assess Glycemic Control and Cardiovascular Outcomes in Patients With Pre-T2D or T2D and NAFLD/NASH
A Phase 3 study testing MSDC-0602K in people with Type2 Diabetes and NASH - Nonalcoholic Steatohepatitis, run by Cirius Therapeutics, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type2 Diabetes, NASH - Nonalcoholic Steatohepatitis, Nonalcoholic Steatohepatitis
- What is being tested?
- MSDC-0602K
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,800 participants
- Where
- No sites listed yet
- Study dates
- Jun 2022to Sep 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- HgbA1c >6%
- Diagnosis of Pre-T2D or T2D
- History of macrovascular cardiovascular disease
Who cannot join
- 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
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- 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
- History of alcohol abuse or drug abuse within 6 months prior to Screening Diagnosis at any time of Type 1 diabetes.
- Current or history of recent (≤ 6 months) use of ursodeoxycholic acid.
- Current use of insulin.
- Current use of thiazolidinediones.
- Any history or current concomitant disorder such as haematological, pulmonary, metabolic, endocrine disorders that are severe or life-threatening.
- Use of concomitant medications with a known significant metabolism by CYP2C8 including paclitaxel or repaglinide for the duration of the study.
- History of diabetic ketoacidosis or hyperosmolar non-ketotic coma within the 6 months prior to Screening.
- Known or suspected intolerance or hypersensitivity to the study drugs, closely related compounds such as PPARγ agonists (pioglitazone or rosiglitazone), or any of their stated ingredients.
About this study
Official title: MMONARCh-1: Study of MSDC-0602K, a Modulator of the Mitochondrial Pyruvate Carrier for Outcomes in Patients With Pre Type 2 Diabetes (T2D) or T2D and NAFLD/NASH, Assessed for ImpRoved Glycemic Control and Cardiovascular Outcomes-1
This is a randomized, double-blind study of MSDC-0602K or placebo in subjects with pre-T2D or T2D and evidence of NAFLD/NASH.
Read the detailed description
This is a randomized, double-blind study of MSDC-0602K or placebo given orally once daily to subjects with pre-T2D or T2D and evidence of NAFLD/NASH. Visits will include a Screening Period, a minimum Treatment of 26 weeks, and a Long-Term Follow-up Period during which subjects will continue taking assigned treatment.
Safety will be assessed by periodic measurement of vital signs, physical examinations, blood laboratory analyses, and the occurrence of adverse events.
- Conditions
- Type2 Diabetes, NASH - Nonalcoholic Steatohepatitis, Nonalcoholic Steatohepatitis, Non-Alcoholic Fatty Liver Disease
- Being tested
- MSDC-0602K, Placebo
- Keywords
- Diabetes, NASH, NAFLD
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSDC-0602KDrug
MSDC-0602K tablet
PlaceboDrug
Matching tablet
| Study group | Role | What they receive |
|---|---|---|
| MSDC-0602K | Active comparator | MSDC-0602K one tablet per day taken orally Receives: Drug: MSDC-0602K |
| Placebo | Placebo comparator | Placebo one tablet per day taken orally Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glycosylated hemoglobin (HbA1c) from baseline to Week 26
Measured: 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.
Measured: 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.
Measured: 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.
A liver event consists of ascites (confirmed by paracentesis or abdominal imaging), hepatic encephalopathy (defined clinically), variceal hemorrhage (confirmed by endoscopy), or liver transplant.
Measured: through study completion, an expected average of 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study startJun 2022 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cirius Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03970031
- Sponsor's protocol ID
- CTI-0602K-C013
- Status last verified
- Jul 2021
- First submitted
- 29 May 2019
- Last updated
- 12 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MMONARCh-1: Study of MSDC-0602K, a Modulator of the Mitochondrial Pyruvate Carrier for Outcomes in Patients With Pre Type 2 Diabetes (T2D) or T2D and NAFLD/NASH, Assessed for ImpRoved Glycemic Control and Cardiovascular Outcomes-1
- ClinicalTrials.gov ID
- NCT03970031
- Acronym / sponsor ID
- CTI-0602K-C013
- Conditions
- Type2 Diabetes, NASH - Nonalcoholic Steatohepatitis, Nonalcoholic Steatohepatitis, Non-Alcoholic Fatty Liver Disease
- Keywords
- Diabetes, NASH, NAFLD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- Cirius Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2022 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 31 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blind study of MSDC-0602K or placebo in subjects with pre-T2D or T2D and evidence of NAFLD/NASH.
Detailed description
This is a randomized, double-blind study of MSDC-0602K or placebo given orally once daily to subjects with pre-T2D or T2D and evidence of NAFLD/NASH. Visits will include a Screening Period, a minimum Treatment of 26 weeks, and a Long-Term Follow-up Period during which subjects will continue taking assigned treatment.
Safety will be assessed by periodic measurement of vital signs, physical examinations, blood laboratory analyses, and the occurrence of adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MSDC-0602K | Active comparator | Drug: MSDC-0602KMSDC-0602K one tablet per day taken orally |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo one tablet per day taken orally |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MSDC-0602KMSDC-0602K tablet | Drug | MSDC-0602K |
| PlaceboMatching tablet | Drug | Placebo |
Primary outcome
Change in glycosylated hemoglobin (HbA1c) from baseline to Week 26
Time frame: 26 weeks
Change in the weighted average of standardized AST, CK-18, and HbA1c values (standard deviations) from baseline to Week 26
Time frame: 26 weeks
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.
2 secondary outcomes
Time to first event of death, adjudicated nonfatal MI or USA hospitalization, adjudicated hospital admission for HF, or adjudicated nonfatal ischemic stroke.
Time frame: 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.
Time frame: through study completion, an expected average of 15 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MSDC-0602K in people with Type2 Diabetes and NASH - Nonalcoholic Steatohepatitis, run by Cirius Therapeutics, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in glycosylated hemoglobin (HbA1c) from baseline to Week 26 (time frame: 26 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2021.