Clinical Trials

Numerous clinical trials evaluate resmetirom (MGL-3196) across Phases 1 through 4, focusing primarily on hepatic and metabolic conditions—including non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH), metabolic dysfunction-associated steatohepatitis (MASH), metabolic dysfunction-associated steatotic liver disease (MASLD), liver cirrhosis, heterozygous familial hypercholesterolemia, and renal impairment—alongside studies in healthy subjects. Supported by industry sponsors such as Madrigal Pharmaceuticals and Sagimet Biosciences, as well as academic institutions like the City University of New York, these studies encompass completed, actively recruiting, active non-recruiting, and planned Phase 4 evaluations.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07763015 NOT_YET_RECRUITING
MASH; MASH - Metabolic Dysfunction-Associated Steatohepatitis
Madrigal Pharmaceuticals, Inc.
 2026-08 PHASE2
NCT07335601 RECRUITING
MASH - Metabolic Dysfunction-Associated Steatohepatitis
Madrigal Pharmaceuticals, Inc.
 2025-12-29 PHASE2
NCT07680478 NOT_YET_RECRUITING
Metabolic Dysfunction-Associated Steatohepatitis (MASH)
City University of New York
 2026-10-01 PHASE4
NCT03900429 ACTIVE_NOT_RECRUITING
NASH - Nonalcoholic Steatohepatitis
Madrigal Pharmaceuticals, Inc.
 2019-03-28 PHASE3
NCT07143968 RECRUITING
MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease; HIV (Human Immunodeficiency Virus)
Naga P. Chalasani
 2026-04-23 PHASE2
NCT04951219 ACTIVE_NOT_RECRUITING
Non-Alcoholic Fatty Liver Disease
Madrigal Pharmaceuticals, Inc.
 2021-07-09 PHASE3
NCT05500222 ACTIVE_NOT_RECRUITING
NASH; Cirrhosis, Liver
Madrigal Pharmaceuticals, Inc.
 2022-08-26 PHASE3
NCT07249788 RECRUITING
MASH - Metabolic Dysfunction-Associated Steatohepatitis
Nabiqasim Industries (Pvt) Ltd
 2025-10-17 PHASE4
NCT07216313 COMPLETED
Healthy
Sagimet Biosciences Inc.
 2025-09-30 PHASE1
NCT06397872 COMPLETED
Renal Impairment
Madrigal Pharmaceuticals, Inc.
 2024-03-06 PHASE1
NCT04197479 COMPLETED
Non-Alcoholic Fatty Liver Disease
Madrigal Pharmaceuticals, Inc.
 2019-12-16 PHASE3
NCT04643795 COMPLETED
Hepatic Impairment; NASH - Nonalcoholic Steatohepatitis; Cirrhosis, Liver
Madrigal Pharmaceuticals, Inc.
 2018-10-25 PHASE1
NCT04951219 Recruiting
Non-Alcoholic Fatty Liver Disease
Madrigal Pharmaceuticals Inc.
 2021-07-09 Phase 3
NCT04197479 Completed
Non-Alcoholic Fatty Liver Disease
Madrigal Pharmaceuticals Inc.
 2019-12-16 Phase 3
NCT04671069 COMPLETED
Healthy
Madrigal Pharmaceuticals, Inc.
 2019-07-26 PHASE1
NCT04671069 Completed
Healthy
Madrigal Pharmaceuticals Inc.
 2019-07-26 Phase 1
NCT03900429 Active not recruiting
NASH - Nonalcoholic Steatohepatitis
Madrigal Pharmaceuticals Inc.
 2019-03-28 Phase 3
NCT04671056 COMPLETED
Healthy
Madrigal Pharmaceuticals, Inc.
 2018-11-09 PHASE1
NCT04671056 Completed
Healthy
Madrigal Pharmaceuticals Inc.
 2018-11-09 Phase 1
NCT03413124 COMPLETED
Healthy
Madrigal Pharmaceuticals, Inc.
 2018-02-05 PHASE1
NCT03038022 COMPLETED
Heterozygous Familial Hypercholesterolemia
Madrigal Pharmaceuticals, Inc.
 2017-02-23 PHASE2
NCT02912260 COMPLETED
Non-alcoholic Steatohepatitis
Madrigal Pharmaceuticals, Inc.
 2016-10-18 PHASE2
NCT03220165 COMPLETED
Healthy
Madrigal Pharmaceuticals, Inc.
 2017-08-06 PHASE1
NCT03220165 Completed
Healthy
Madrigal Pharmaceuticals Inc.|Worldwide Clinical Trials
 2017-08-06 Phase 1
NCT02749578 COMPLETED
Healthy
Madrigal Pharmaceuticals, Inc.
 2016-04 PHASE1
NCT02542969 COMPLETED
Healthy
Madrigal Pharmaceuticals, Inc.
 2015-09 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-08-13)

Check the MGL-3196 (Resmetirom) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Resmetirom (MGL-3196) functions as a liver-directed, selective thyroid hormone receptor β (THR-β) agonist that binds hepatic THR-β with an EC50 of 0.21 μM, selectively stimulating thyroid hormone signaling in hepatocytes to promote mitochondrial β-oxidation and reduce intrahepatic lipid accumulation. By enhancing hepatic lipid clearance and mitigating lipotoxicity without activating systemic THR-α receptors, resmetirom directly targets the underlying metabolic dysfunction driving non-alcoholic steatohepatitis (NASH/MASH) and non-alcoholic fatty liver disease (NAFLD).

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.