A clinical trial to evaluate the efficacy and safety of Miricorilant in adult patients with Nonalcoholic Steatohepatitis or Metabolic
Dysfunction-Associated Steatohepatitis
Scientific Title of Study
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled
Study Evaluating the Efficacy and Safety of Miricorilant in
Adult Patients with Nonalcoholic Steatohepatitis Metabolic
Dysfunction-Associated Steatohepatitis (MONARCH)
Trial Acronym
MONARCH
Secondary IDs if Any
Secondary ID
Identifier
CORT118335-862 Amendment 2.0 dated 23 May 2024
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Designation
Affiliation
Address
Phone
Fax
Email
Details of Contact Person Scientific Query
Name
Dr Sawan Bopanna
Designation
Medical Monitor
Affiliation
KlinEra Global Services
Address
KlinEra Global Services, 801, Neelkanth Corporate Park, Near Vidyavihar Station, Vidhyavihar West, Mumbai, India
Mumbai MAHARASHTRA 400086 India
Phone
912249781252
Fax
Email
sbopanna@klinera.com
Details of Contact Person Public Query
Name
Mr Pritesh Tailor
Designation
Sr. Clinical Project Manager
Affiliation
KlinEra Global Services
Address
KlinEra Global Services,
801, Neelkanth Corporate Park,
Near Vidyavihar Station,
Vidhyavihar West, Mumbai, India
Mumbai MAHARASHTRA 400086 India
Phone
917045947271
Fax
Email
ptailor@klinera.com
Source of Monetary or Material Support
Corcept Therapeutics Incorporated
149 Commonwealth Drive
Menlo Park, California 94025 US
Primary Sponsor
Name
M/s KlinEra Global Services
Address
801, Neelkanth Corporate Park,
Near Vidyavihar Station,
Vidhyavihar West, Mumbai
400 086, Maharashtra, India
Alfa Gastro and Liver Care, 207, 208, Second Floor, Dream Square complex, Near Nirnayanagar underbridge, Opp. Ramdevpeer ji Maharaj Mandir, Akhabarnagar, Ahmedabad-380013 Ahmadabad GUJARAT
918424076444 -- vatsalmehta6387@gmail.com
Dr Shalimar Sushil Kumar
All India Institute of Medical Sciences
Room No.127, First Floor, Old OT Block, AIIMS, Ansari Nagar, Delhi-110029, India New Delhi DELHI
919868397211 - drshalimar@yahoo.com
Dr Rohit Gupta
All India Institute of Medical Sciences, Rishikesh
Department of Gastroenterology, 6th Floor, All India Institute of
Medical Sciences, Virbhadra Road, Shivaji Nagar, Rishikesh,
Uttarakhand-249203, India Dehradun UTTARANCHAL
917479067715
docgupta1976@gmail.com
Dr Nitin Borse
Apex Wellness Hospital
Behind Prakash Petrol Pump, Govind Nagar, Nashik-422009, Maharashtra, India
Nashik MAHARASHTRA
919822011684 -- nitinborse@hotmail.com
Dr Madhusudhanan Jegadeesan
Apollo Speciality Hospitals
Room No: 42, C-Block, Ground Floor, Apollo Speciality Hospitals, Lake View Road, K.K Nagar, Madurai-625020, Tamil Nadu, India Madurai TAMIL NADU
919717762502 914522581154 gi.hpbsurgeon@gmail.com
Dr Prashant Katiyar
Atharva Multispeciality Hospital and Research Centre
H4/Com-2 Construction DIV-21, Avas Vikas Parishad, IIM Road, Lucknow-226003, India Lucknow UTTAR PRADESH
917897575716 05227118215 docpkatiyar@gmail.com
Dr Parshottam Govindbhai Koradia
BAPS Pramukh Swami Hospital
BAPS Pramukh Swami Hospital Second Floor, Shri Pramukh Swami Maharaj Marg, Adajan Char Rasta, Adajan, Surat - 395009, Gujarat, India
Surat GUJARAT
Belagavi Institute of Medical Science, Dr B.R. Ambedkar Road, Belagavi, Karnataka 590001 Belgaum KARNATAKA
917892713562 -- bimsclinicalresearch@gmail.com
Dr Rathi Pravin Motilal
BYL Nair Hospital & TNMC
, OPD Building, 7th Floor, Dr. A.L. Nair
Road, Mumbai Central, Mumbai- 400008, Maharashtra, India Mumbai MAHARASHTRA
919322406438 -- rathipmpp@gmail.com
Dr Abhijit Chowdhury
Centre for Clinical Research
Centre for Clinical Research, John C. Martin Centre for Liver Research & Innovations (CCR-JCMLRI),
Indian Institute of Liver and Digestive Sciences Campus, Sitala East, Sonarpur, Kolkata - 700150, West Bengal, India
Kolkata WEST BENGAL
Deep Hospital, 481, Model Town, Ludhiana-141002, Punjab, India Ludhiana PUNJAB
918427000080 - drbehlresearch@gmail.com
Dr Shivam Khare
Department of Institute of Liver Gastroenterology & Pancreatico Biliary Sciences
Room # Liver Research Room,
1st Floor, Admission Building, Sir Ganga Ram Hospital,
Rajinder Nagar, New Delhi 110060, India New Delhi DELHI
917838582169
drshivamkhare01@gmail.com
Dr Sanjay Gupta
Digestive Diseases Centre
Digestive Diseases Centre, 2, Ankit Puram, GMS Road,
Dehradun, Uttarakhand-248001, India Dehradun UTTARANCHAL
919997711444
doonddc@gmail.com
Dr Ravindra Gaadhe
Gastroplus Digestive Disease Centre
3rd floor, Gastroplus Digestive Disease Centre D- Block, Galaxy bazar, Sunrise park road, Vastrapur, Ahmedabad-380054, Gujarat, India Ahmadabad GUJARAT
919276558517 - ravindragaadhe@gmail.com
Dr Anjan Jyoti Talukdar
Gauhati Medical College and Hospital
3rd Floor, Department of Medicine, OPD Building,
Gauhati Medical College and Hospital, Narakasur Hilltop,
Bhangagarh, Guwahati-781032, Assam, India Kamrup ASSAM
919954658926
anjan11078@gmail.com
Dr Krishnadas Devadas
Government Medical College, Thiruvananthapuram
Government Medical College, Thiruvananthapuram, Department of Medical Gastroenterology, Superspeciality block, Government Medical college PO, Thiruvananthapuram 695011, Kerala, India Thiruvananthapuram KERALA
919847111824 - kdas40@gmail.com
Dr Siddharth Srivastava
Govind Ballabh Pant Institute of Postgraduate Medical Education and Research (GIPMER)
Govind Ballabh Pant Institute of Postgraduate Medical
Education and Research, 1 Jawahar Lal Nehru Marg, New
Delhi-110002 New Delhi DELHI
919718599215
docsiddharth1@gmail.com
Dr Saumin Prakashbhai Shah
Gujarat Gastro & Vascular Hospital
Opposite Shree Ram Petrol Pump, Anand Mahal Road, Adajan,
Surat-395009, Gujarat, India Surat GUJARAT
919408042224 -- dr.sauminpshah@gmail.com
Dr Shiv Kumar Sarin
Institute of Liver & Biliary Sciences
Room No 22066, OPD Phase II area, ILBS,D-1,Vasant Kunj, New Delhi-110070, India New Delhi DELHI
91-01146300000
shivsarin@gmail.com
Dr Dawesh Prakash Yadav
Institute of Medical Sciences, Banaras Hindu University
2nd Floor, Department of Gastroenterology, Institute of Medical
Sciences, Banaras Hindu University, Varanasi-221005, Uttar Pradesh, India Varanasi UTTAR PRADESH
918130856563
devesh.thedoc@gmail.com
Dr Sk Mahiuddin Ahammed
Institute of Post Graduate Medical Education & Research (IPGME&R), SSKM Hopsital
Department of Hepatology, School of Digestive & Liver Diseases (SDLD), Institute of Post Graduate Medical Education & Research (IPGME&R), SSKM Hospital, 244, A. J.C. Bose Road, Kolkata, PIN-700020, West Bengal, India Kolkata WEST BENGAL
Department of Medicine, King George’s Medical University,
Chowk, Lucknow, Uttar Pradesh 226003, India Lucknow UTTAR PRADESH
919455519306
drajaymd12345@gmail.com
Dr Keyur Ashok Sheth
Lifelline Medicare Hospitals
Lifelline Medicare Hospitals, Ground Floor, DLH Park, S.V.
Road, Near MTNL Signal, Sunder Nagar, Goregaon West,
Mumbai-400062, Maharashtra, India Mumbai MAHARASHTRA
919930553321
drshethkeyur55@gmail.com
Dr Shinde Kiran Dhananjay
MAEER’s VishwaRaj Hospital
MAEER’s VishwaRaj Hospital, Dept. of Gastroenterology, 2nd
Floor, Near Loni Railway Station, Solapur - Pune Highway,
Loni, Kalbhor, Pune-412201, Maharashtra, India Pune MAHARASHTRA
919986003257
drkiranshinde@gmail.com
Dr Saubhik Ghosh
Medical College and Hospital, Kolkata
Medical College and Hospital, Kolkata, 88 College Street, Kolkata - 700073,
West Bengal, India Kolkata WEST BENGAL
918017585988
souvikpgi@gmail.com
Dr Dharmendra B L
Mysore Medical College & Research Institute
K.R. Hospital- Princess Krishnajammanni Super Speciality HospitalDept. of Surgical Gastroenterology, 1st Cross Rd., Brindavan Extension 1st Stage, Opp. ESI Hospital, Mysuru, Karnataka-570015, India Mysore KARNATAKA
919844400382 -- drdharmu21@gmail.com
Dr Jayanta Samanta
Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh
Department of Gastroenterology,
F-Block, Nehru Hospital, Postgraduate Institute of Medical
Education & Research (PGIMER), Madhya Marg, Sector12, Chandigarh- 160012, India Chandigarh CHANDIGARH
919855319529
dj_samanta@yahoo.co.in
Dr Avval Sadikot
Prime Institute of Digestive Sciences Pvt. Ltd.
Panchvati Society Main Road,
Atithi Chowk, Nana Mava Main Road, Nr. Chandresh Vadi,
Rajkot - 360001, Gujarat, India Rajkot GUJARAT
919724054996 -- dravvalsadikot@gmail.com
Dr Sandeep Goyal
Pt. B. D. Sharma PGIMS Hospital
Pt. B.D. Sharma PGIMS Hospital, Department of Medicine, Medical Road, Rohtak-124001, Haryana, India
Rohtak HARYANA
S R Kalla Memorial Gastro & General Hospital, 78-79, Dhuleshwar Garden, Behind HSBC Bank, Sardar Patel Marg, C-Scheme, Jaipur-302001, Rajasthan, India Jaipur RAJASTHAN
919829050622 911414020622 drmkalla@rediffmail.com
Dr Mukesh Kumar Jain
S. M.S Super Specialty Hospital
Dept. of Gastroenterology, Vivekananda Marg, C-Scheme
Jaipur, 302004, India
Jaipur RAJASTHAN
Miricorilant (Cohort A) : Miricorilant 100 mg for oral dosing
Miricorilant is a synthetically produced small molecule and it is a selective modulator of Glucocorticoid and Mineralocorticoid-Receptors.
Patients who meet the entry criteria for study CORT118335-862 (Cohort A) will be enrolled to receive 100 mg of miricorilant, twice a week for 48 weeks.
Intervention
Miricorilant (Cohort B): Miricorilant 100 mg for oral dosing , Miricorilant 200 mg for oral dosing
Patients who meet the entry criteria for study CORT118335-862 (Cohort B) will be enrolled to receive 100 mg of miricorilant, twice a week for 6 weeks. Dose will be escalated to 200 mg of miricorilant, twice a week for 18 weeks
Comparator Agent
Placebo (Cohort A): Matching placebo for oral dosing for 48 Weeks
Placebo for Miricorilant is designed to match the study drug in appearance. It is oval shaped and is white to off-white in color. Patients who meet the entry criteria for study CORT118335-862 (Cohort A) will be enrolled to receive a matching placebo twice a week for 48 weeks.
Comparator Agent
Placebo (Cohort B): Matching placebo for oral dosing for 24 Weeks
Patients who meet the entry criteria for study CORT118335-862 (Cohort B) will be enrolled to receive a matching placebo twice a week for 24 weeks.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
75.00 Year(s)
Gender
Both
Details
1 Have provided informed consent.
2. Are adults greater than or equal to 18 to lesser than or equal to 75 years old.
3. FibroScan liver stiffness measurement greater than or equal to 8 kPa and CAP greater than or equal to 280 dB/m. The FibroScan inclusion criterion does not apply to participants with an eligible historical liver biopsy performed within 6 months of Screening with reading confirmed by a consensus panel to meet inclusion criterion 5.
4. MRI-PDFF with greater than or equal to 8% steatosis, this assessment must be performed within 6 weeks of the Baseline visit (Day 1).
5. Liver biopsy that meets the following criteria: A historical liver biopsy within 6 months of Screening with reading confirmed during the Screening period by a consensus panel is acceptable. a. Cohort A: Have a histological diagnosis of MASH with NAFLD Activity Score (NAS) greater than or equal to 4 (greater than or equal to 1 point in each subcomponent of steatosis, inflammation, and ballooning) and a NASH CRN fibrosis score of 2 or 3 based on the consensus method of histological assessment. b. Cohort B: Have a liver biopsy result that does not meet the criteria for inclusion in Cohort A and is consistent with one of the following scenarios based on the consensus method of histological assessment: i. NAS greater than or equal to 3 with greater than or equal to1 point in each subcomponent of steatosis, inflammation, and ballooning, and a NASH CRN fibrosis score of F1 OR ii. NAS greater than or equal to 2 with greater than or equal to 1 point in subcomponent of steatosis and greater than or equal to 1 point in subcomponent of ballooning or inflammation, and a NASH CRN fibrosis score of F2 or 3.
6. Have a stable weight since the liver biopsy was performed, defined by no more than a 5% loss of initial body weight.
7. Agree to have a liver biopsy performed after 48 weeks of treatment (Cohort A)
8. AST greater than 17 U/L for women and AST greater than 20 U/L for men. The AST inclusion criterion does not apply to participants with an eligible historical liver biopsy performed within 6 months of Screening with reading confirmed by a consensus panel to meet inclusion criterion 5.
9. Presence of at least 1 of the following metabolic syndromes that increase the risk of MASH: a. Diagnosis of type 2 diabetes OR b. Presence of 3 or more components of metabolic syndrome: i. Fasting blood glucose greater than or equal to 100 mg/dL (5.6 mmol/L) or treatment for elevated blood glucose ii. Systolic blood pressure greater than or equal to 130 mm Hg, diastolic blood pressure greater than or equal to 85 mm Hg, or treatment for hypertension iii. Serum triglycerides greater than or equal to 150 mg/dL (1.7 mmol/L) or drug treatment for elevated triglycerides iv. Serum high-density lipoprotein (HDL) cholesterol lesser than 40 mg/dL (1 mmol/L) in men and lesser than 50 mg/dL (1.3 mmol/L) in women or drug treatment for low HDL v. Overweight or obese (body mass index [BMI] greater than or equal to 25 kg/m2 [BMI greater than or equal to 23 kg/m2 in Asians]), or increased waist circumference greater than or equal to 102 cm (40 in) in men and greater than or equal to 88 cm (35 in) in women (men greater than or equal to 90 cm [35.4 in], women greater than or equal to 80 cm [31.5 in] in Asians) 10. Male and female patients of childbearing potential must agree to use a protocol-specified method of contraception throughout the study, including the Screening period, and for at least 28 days after the last dose of assigned treatment
ExclusionCriteria
Details
1. Have participated in another clinical trial within the last 3 months of Screening where the patient received active treatment for MASH. 2. Have participated in a clinical trial for any other indication within the last 3 months or 5 half-lives of the treatment, whichever is longer. 3. Have participated in another study with miricorilant within 3 months prior to Screening. 4. Women who are pregnant, planning to become pregnant, or are lactating. 5. Have a BMI lesser than 18 kg/m2 or greater than 45 kg/m2. 6. Are currently using any medications prohibited due to the potential for drug-drug interactions (DDI) with study treatments. Prohibited medications (see Section 5.4.2) must be discontinued at least 5 half-lives prior to a patient receiving their first study treatment. 7. Have had a successful weight-loss surgery within 2 years prior to Screening or are planning weight-loss surgery during the study. 8. Have a greater than 5% weight change within 3 months prior to Screening. 9. Have significant alcohol consumption, defined as more than 2 drink units per day (equivalent to 20 g of ethanol) in women and 3 drink units per day (equivalent to 30 g of ethanol) in men for greater than or equal to 3 consecutive months within 1 year prior to Screening, inability to reliably quantify alcohol intake, or score a value greater than or equal to 8 on the Alcohol Use Disorders Identification Test (AUDIT) questionnaire. 10. Have phosphatidylethanol (PEth) greater than 50. 11. Use of drugs associated with MASLD (eg, amiodarone, methotrexate, tamoxifen, estrogens at doses greater than those used for hormone replacement or contraception, anabolic steroids, or valproic acid) for more than 4 weeks in the 2 months prior to enrollment. 12. Have been treated with resmetirom within 3 months prior to Screening. 13. Are currently on pioglitazone, or high-dose Vitamin E (greater than 800 IU/day) unless on stable dose for at least 6 months prior to Baseline visit; maximum dose of pioglitazone allowed is 15 mg a day; patients on Vitamin E doses lesser than or equal to 800 IU/day for any duration are eligible to participate in the study. 14. Are on lipid-modifying therapies unless on a stable dose for at least 6 weeks prior to Baseline visit (and at least 4 weeks prior to screening MRI-PDFF), maximum dose of rosuvastatin allowed is 10 mg a day. 15. Are on glucagon-like peptide-1 (GLP-1) agonists or other anti-obesity compounds unless on a stable dose for at least 6 months prior to Baseline visit. 16. Are using a medication such as digoxin with an increased risk for toxicity in the event of electrolyte changes. 17. Have had liver transplantation or plan to have liver transplantation during the study. 18. Have type 1 diabetes. 19. Have poorly controlled type 2 diabetes with an HbA1c greater than or equal to 9.5%, an insulin dose adjustment greater than 20% within 60 days prior to Baseline visit, are on GLP-1 agonists unless on a stable dose for at least 6 months prior to Baseline visit, or are on other diabetes medication unless on a stable dose for at least 3 months prior to and during Screening. 20. Have abnormal screening laboratories, a. AST greater than 5 × ULN b. ALT greater than 5 × ULN c. Estimated glomerular filtration rate (eGFR) lesser than 60 mL/min/1.73 m2 d. Creatine kinase greater than 3 × ULN 21. Have known or suspected cirrhosis based on the opinion of the Investigator. A patient who presents with possible signs of suspected cirrhosis listed below will be excluded from the study, a. Physical exam findings, i. Jaundice b. Laboratory findings, i. Direct bilirubin greater than 0.3 mg/dL. Note, For patients who have Gilbert’s syndrome see exclusion criterion 23.f ii. Platelet count lesser than 140,000/µL c. Imaging, i. Evidence of portal hypertension (dilated portal vein, presence of varices) ii. Evidence of a nodular liver with splenomegaly d. Endoscopy, i. Evidence of esophageal varices 22. Have hepatic decompensation defined as the presence of any of the following, a. Serum albumin lesser than 3.5 g/dL b. International normalized ratio (INR) greater than 1.3 (unless due to therapeutic anticoagulants) c. Total bilirubin greater than 1.3 mg/dL. Note for patients who have Gilbert’s syndrome see exclusion criterion 23.f d. History of esophageal or gastric variceal bleedings, ascites, or hepatic encephalopathy 23. Have any other chronic liver disease, a. Hepatitis B as defined by presence of hepatitis B surface antigen b. Hepatitis C as defined by presence of hepatitis C virus (HCV) antibody and positive HCV RNA. Documented cured HCV infection is acceptable if greater than 3 years from Screening visit c. History or evidence of current active autoimmune hepatitis d. History or evidence of primary biliary cholangitis e. History or evidence of primary sclerosing cholangitis f. History or evidence of Gilbert’s syndrome if direct bilirubin is greater than 0.3 mg/dL and total bilirubin greater than or equal to 2mg/dL or evidence of hemolysis contributing to elevated total bilirubin g. History or evidence of Wilson’s disease h. History or evidence of alpha-1-antitrypsin deficiency i. History or evidence of hemochromatosis j. History or evidence of drug-induced liver disease, as defined on the basis of typical exposure and history k. Known bile duct obstruction l. Suspected or proven liver cancer m. Any other type of liver disease other than MASH 24. Have a history of biliary diversion. 25. Are seropositive for human immunodeficiency virus. 26. Have a history of cancer within the last 3 years prior to Screening except for patients with a history of in situ carcinomas, cutaneous basal cell or squamous cell cancer resolved by excision. 27. Have contraindications to magnetic resonance imaging (MRI). 28. Have a clinically significant ECG abnormality as judged by the Investigator. 29. Have a confirmed baseline QTcF greater than 450 ms for men and QTcF greater than 470 ms for women in the presence of a normal QRS interval (QRS lesser than 120 ms), a QTcF interval greater than 500 ms with a wide QRS interval (greater than or equal to 120 ms), or a history of additional risk factors for torsades de pointes. 30. New York Heart Association class III or IV heart failure or known left ventricular ejection fraction lesser than 30%. 31. Uncontrolled hypertension (either treated or untreated) defined as systolic blood pressure greater than 160 mm Hg or a diastolic blood pressure greater than 100 mm Hg at Screening. 32. Myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass graft, or stroke within 3 months prior to Screening. 33. Positive urine drug screen for amphetamines, cocaine or opiates (ie, heroin, morphine) at Screening. Patients on stable methadone or buprenorphine maintenance treatment for at least 6 months prior to Screening may be included in the study. Patients with a positive urine drug screen due to prescription opioid-based medication or amphetamine salts for the treatment of attention-deficit hyperactivity disorder or narcolepsy are eligible if the prescription and diagnosis are reviewed and approved by the Investigator. 34. Have any clinical condition or significant concurrent disease judged by the Investigator to complicate the evaluation of the study treatment. 35. Are a family member of one of the Sponsor’s employees, the Investigator, or the site staff. 36. Are directly working on the study or are a contractor directly involved in the conduct of the trial. 37. Have an allergic reaction or hypersensitivity to miricorilant tablets or any of its components. 38. In the opinion of the Investigator, unwilling or unable to participate in all study evaluations and procedures
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
Percent relative change from Baseline in liver-fat content assessed by MRI-PDFF (Cohort A and Cohort B)
Week 24
Secondary Outcome
Outcome
TimePoints
Change in liver stiffness and Controlled Attenuation Parameter (CAP) by FibroScan. (Cohort A and Cohort B at Week 24, Cohort A at Week 48)
Week 24 and 48
Change in absolute body weight (Cohort A and B at Week 24, Cohort A at Week 48)
Week 24 and 48
Change in lipids - total cholesterol, HDL, LDL, VLDL, TG, serum free fatty acids, apolipoproteins (Cohort A and Cohort B at Week 24, Cohort A at Week 48)
Week 24 and 48
Change in Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) (Cohort A and Cohort B at Week 6 and 24, Cohort A at Week 48)
Week 6, 24 and 48
Change in ELF, Pro-C3 and other markers of liver fibrosis (Cohort A and B at Week 24, Cohort A at Week 48)
Week 24 and 48
Improvement in liver fibrosis stage by at least 1-point (NASH CRN fibrosis score) from Baseline and no worsening of steatohepatitis at Week 48 assessed by biopsy (Cohort A).
Week 48
Resolution of steatohepatitis (defined as a ballooning grade of 0 and a lobular inflammation grade of ≤ 1) and no worsening of liver fibrosis at Week 48 assessed by biopsy (Cohort A).
Week 48
Target Sample Size
Total Sample Size="225" Sample Size from India="125" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
Phase 2
Date of First Enrollment (India)
07/01/2025
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
25/10/2023
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="2" Months="0" Days="0"
Recruitment Status of Trial (Global)
Closed to Recruitment of Participants
Recruitment Status of Trial (India)
Closed to Recruitment of Participants
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
CORT118335-862 is a Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study in patients with biopsy confirmed or presumed non-cirrhotic MASH to evaluate the efficacy, safety, tolerability, and PK of miricorilant. The study will be conducted in 2 cohorts (Cohort A and Cohort B). Cohort A will include approximately 150 patients with biopsy-confirmed non-cirrhotic (F2-3) MASH. Cohort B will include approximately 75 patients with presumed non-cirrhotic MASH. The study will be conducted across 30 centers in India. The duration of study drug is 48 weeks for Cohort A subjects whereas it is maximum up to 24 weeks for Cohort B subjects. The drug (Miricorilant or Placebo Tablet) is administered orally twice weekly in the ratio of 2:1 in both Cohort A and B subjects.