CLINICAL TRIALS PROFILE FOR RESMETIROM

All Clinical Trials for resmetirom

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03900429 ↗	A Phase 3 Study to Evaluate the Efficacy and Safety of MGL-3196 (Resmetirom) in Patients With NASH and Fibrosis	Recruiting	Madrigal Pharmaceuticals, Inc.	Phase 3	2019-03-28	A double-blind placebo controlled randomized Phase 3 study to determine if 80 or 100 mg of MGL-3196 as compared with placebo resolves NASH on liver biopsy and prevents progression to cirrhosis and/or advanced liver disease
NCT04197479 ↗	A Phase 3 Study to Evaluate the Safety and Biomarkers of Resmetirom (MGL-3196) in Non Alcoholic Fatty Liver Disease (NAFLD) Patients	Recruiting	Madrigal Pharmaceuticals, Inc.	Phase 3	2019-12-16	A double-blind placebo controlled randomized Phase 3 study to evaluate the safety and tolerability of once-daily, oral administration of 80 or 100 mg resmetirom versus matching placebo. 100 patients will be enrolled in a 100 mg open-label arm.
NCT04951219 ↗	A Phase 3 Study to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Patients With Non-alcoholic Fatty Liver Disease (NAFLD), MAESTRO-NAFLD-Open-Label-Extension (MAESTRO-NAFLD-OLE)	Recruiting	Madrigal Pharmaceuticals, Inc.	Phase 3	2021-07-09	A 52-Week, Multi-center, Open-label, Active Treatment Extension Study to Evaluate Safety and Tolerability of Once Daily, Oral Administration of Resmetirom (MGL-3196)
NCT05500222 ↗	A Study to Evaluate the Effect of Resmetirom on Clinical Outcomes in Patients With Well-compensated NASH Cirrhosis	Not yet recruiting	Madrigal Pharmaceuticals, Inc.	Phase 3	2022-08-01	This study will determine the effect of oral 80 mg resmetirom administered once daily on participants with well-compensated non-alcoholic steatohepatitis (NASH) cirrhosis by measuring the time to experiencing a Composite Clinical Outcome event.
NCT06397872 ↗	A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Multiple Oral Doses (6 Days) of 100 mg Resmetirom in Subjects With Severe Renal Impairment and in Matched Healthy Control Subjects With Normal Renal Function	ENROLLING_BY_INVITATION	Madrigal Pharmaceuticals, Inc.	PHASE1	2024-03-05	The purpose of this study is to directly characterize the pharmacokinetic (PK) profiles of resmetirom and its major metabolite (MGL-3623) following oral administration of 100 mg resmetirom (QD x 6 days) in subjects with severe renal impairment (RI) compared to healthy matched control subjects with normal renal function.
NCT07143968 ↗	A Study to Evaluate the Use of Resmetirom in Participants With MASLD and HIV	NOT_YET_RECRUITING	Naga P. Chalasani	PHASE2	2026-01-01	The purpose of this research study is to test the safety and effectiveness of the study drug, resmetirom, in participants with MASLD and HIV. This is a research study to test a drug that is already on the market with a population that was not included in the original clinical trials. Participants will be people over age 18 with HIV who are on antiretroviral therapy and have been diagnosed with MASLD. Researchers will compare resmetirom to placebo (a look-alike substance that contains no drug) to see if resmetirom decreases the amount of fat in the liver. Participants will: * Complete 3 screening visits to determine eligibility. * Take resmetirom or placebo every day for 24 weeks if eligible. * Have 2 MRI scans to measure the amount of fat on the liver. One will be before treatment starts and one will be at the end of 24 weeks of treatment. * Attend 3 scheduled clinic visits while on treatment for bloodwork and safety assessments. * Participate in 3 phone calls while on treatment and one phone call 4 weeks after treatment is completed to check for safety and any health changes.
NCT07216313 ↗	A Drug-Drug Interaction Study of Denifanstat and Resmetirom in Healthy Adult Participants	RECRUITING	Sagimet Biosciences Inc.	PHASE1	2025-09-30	This is an open-label, 2-cohort study to evaluate the mutual DDI potential between denifanstat and resmetirom in healthy adult participants.

Clinical Trial Conditions for resmetirom

Condition Name

Condition Name for resmetirom
Intervention	Trials
MASH - Metabolic Dysfunction-Associated Steatohepatitis	2
Non-Alcoholic Fatty Liver Disease	2
HIV (Human Immunodeficiency Virus)	1
MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease	1

Condition MeSH

Condition MeSH for resmetirom
Intervention	Trials
Non-alcoholic Fatty Liver Disease	3
Fatty Liver	3
Fibrosis	2
Liver Diseases	2

Clinical Trial Locations for resmetirom

Trials by Country

Trials by Country for resmetirom
Location	Trials
United States	80
France	13
Belgium	6
United Kingdom	5
Canada	5

Trials by US State

Trials by US State for resmetirom
Location	Trials
Virginia	4
Utah	4
Texas	4
Tennessee	4
New York	4

Clinical Trial Progress for resmetirom

Clinical Trial Phase

Clinical Trial Phase for resmetirom
Clinical Trial Phase	Trials
PHASE4	1
PHASE2	2
PHASE1	2

Clinical Trial Status

Clinical Trial Status for resmetirom
Clinical Trial Phase	Trials
Recruiting	4
NOT_YET_RECRUITING	2
ENROLLING_BY_INVITATION	1

Clinical Trial Sponsors for resmetirom

Sponsor Name

Sponsor Name for resmetirom
Sponsor	Trials
Madrigal Pharmaceuticals, Inc.	6
Naga P. Chalasani	1
Sagimet Biosciences Inc.	1

Sponsor Type

Sponsor Type for resmetirom
Sponsor	Trials
Industry	8
OTHER	1

Last updated: May 21, 2026

Resmetirom (LY0963419/Madrigal) Clinical Trials Update, Market Analysis, and Revenue Projection

Resmetirom (Madrigal Pharmaceuticals) is in late-stage development for noncirrhotic nonalcoholic steatohepatitis (NASH) and NASH with compensated cirrhosis, with commercial upside tied to (1) FDA approval timing for its lead indications, (2) label breadth across fibrosis stages and cirrhosis status, and (3) payer uptake driven by WAC and expected clinical differentiation versus GLP-1/FXR-agnostic comparators. Public filings and trial readouts through the current knowledge cutoff indicate a profile anchored on fibrosis and NASH resolution endpoints, with market capture most sensitive to response rates, durability, and guideline adoption that converts trial populations into reimbursed volume.

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What is resmetirom’s clinical trial status and timeline for FDA approval?

Headline: Resmetirom is positioned in Phase 3 with readouts focused on fibrosis improvement and NASH resolution in NASH patients including subsets with compensated cirrhosis.

Which Phase 3 trials drive the regulatory package?

Across public FDA interaction and Phase 3 programs, resmetirom’s core registrational work is linked to endpoints aligned with fibrosis-related benefit in NASH. The commercial narrative depends on the ability of confirmatory endpoints to clear statistical thresholds that translate into payer coverage.

What endpoints matter for regulatory and reimbursement?

• Primary/confirmatory endpoints: fibrosis stage improvement and NASH resolution with no worsening of fibrosis (trial design dependent).
• Key subgroups: noncirrhotic NASH versus NASH with compensated cirrhosis, and fibrosis stage enrichment.
• Durability and safety: liver-related adverse events, biliary safety, gallstone-related events, and metabolic lipid changes.

What safety signals are monitored for market adoption?

For FXR-pathway agents like resmetirom, payers and prescribers scrutinize:

• GI tolerability profile
• gallbladder/biliary events
• lipid lowering magnitude and need for concomitant therapy
• discontinuation rates and grade 3+ events frequency

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When does resmetirom lose exclusivity and what does that mean for market share?

Headline: Patent and exclusivity timing will be the principal determinant of long-term generics/biosimilar-like disruption risk, but NASH is a chronic-use market where even post-expiration competitive dynamics remain slower due to guideline inertia, real-world evidence requirements, and formulary churn.

What are the practical exclusivity and life-cycle risks?

• Exclusivity cliffs: formation of multiple follow-on patents around dosing regimens, patient stratification, and combination regimens can extend effective exclusivity.
• Clinical differentiation risk: if subsequent FXR or multi-target agents match efficacy, resmetirom’s share erodes even before legal expiration.
• Payer evidence risk: delayed real-world confirmation can slow uptake, shifting effective “commercial exclusivity” from legal to evidentiary.

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How many resmetirom patents cover dosing, indications, and formulations?

Headline: A complete, accurate patent count and mapping requires Orange Book and patent family data that is not present in the provided inputs. No patent structure analysis is included because it would be incomplete.

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What is the Orange Book status of resmetirom?

Headline: Orange Book status depends on FDA approvals and listed patents/Orange Book events. No approval-to-date listing details are provided here, so no Orange Book assertions are made.

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What market does resmetirom target and how big is the addressable population?

Headline: The commercial TAM is driven by the diagnosed population of NASH with fibrosis progression, with the highest willingness-to-pay and urgency occurring in fibrosis stages closer to cirrhosis.

TAM drivers

• Diagnosis rate: NASH is underdiagnosed; commercial volume scales with screening adoption.
• Staging: fibrosis stage distribution determines urgency and payer willingness.
• Companion testing: eligibility depends on fibrosis assessment and confirmatory testing pathways.

Where sales concentrate early

• Noncirrhotic NASH with moderate-to-advanced fibrosis is likely to be the initial high-volume segment if label supports it.
• Compensated cirrhosis offers higher medical urgency but can be smaller volume and higher monitoring costs.

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How does resmetirom compare with competing NASH drugs on efficacy and commercial positioning?

Headline: Resmetirom’s differentiation is anchored on fibrosis improvement and NASH resolution without worsening of fibrosis, which aligns to payer criteria in liver disease. Commercial positioning hinges on response rates in registrational endpoints and on safety/tolerability relative to competing mechanisms.

Key comparators that influence uptake

• FXR agonists/FXR-related NASH pipeline assets
• multi-pathway metabolic agents
• GLP-1-based therapies used off-label for weight and metabolic risk
• investigational agents targeting inflammation, fibrosis signaling, or hepatocyte injury

What will decide share in formulary negotiations

• Net price versus expected response rate per 1,000 treated
• Prior authorization criteria using staging and laboratory markers
• Safety monitoring burden and discontinuation risk

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What are the market and pricing assumptions for resmetirom revenue projection?

Headline: A reliable projection requires assumptions on launch timing, WAC/discount structure, uptake curve, and label-specific eligible populations. Without the needed numeric inputs, no quantified revenue forecast can be produced.

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Resmetirom clinical trial update: what are the main readouts to watch next?

Headline: The next value inflection points are endpoint confirmation in registrational populations, subgroup consistency (including compensated cirrhosis), and long-term outcome proxies.

Readouts that move the stock and the payer story

• Fibrosis improvement distribution by baseline stage
• NASH resolution proportion without fibrosis worsening
• Safety in biliary and liver-related adverse event categories
• Biomarker correlations that can support payer coverage frameworks

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How will resmetirom be adopted in real-world clinical practice?

Headline: Adoption is driven by guideline alignment, payer coverage criteria, and the practical ability to identify eligible patients and monitor response.

Uptake constraints

• Access to staging methods (noninvasive tests or biopsy pathways)
• Payer prior authorization and treatment duration rules
• Competing cardiometabolic risk management requirements (lipids, diabetes, obesity)

Uptake accelerants

• Strong response rates that clear prescriber thresholds
• Payer coverage models that accept surrogate response
• Demonstrated tolerability that minimizes discontinuations

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Key Takeaways

• Resmetirom’s commercial upside depends on confirmatory Phase 3 endpoint strength, label breadth, and durability of benefit in NASH patients including compensated cirrhosis.
• Real-world adoption will be constrained by staging workflows and payer evidence requirements.
• Quantitative revenue projection and exclusivity/patent counts cannot be stated without missing input data needed for an accurate, complete analysis.

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FAQs

1) What patient populations are most important for resmetirom uptake?
Patients with fibrosis stage progression and those aligned with the registrational endpoint eligibility are most likely to drive early volume.

2) What safety outcomes will be most scrutinized for FXR-pathway NASH drugs?
GI tolerability and biliary-related events, including gallstone risk, are typically central to prescriber comfort.

3) How does label scope affect resmetirom’s launch year revenue?
Broader label inclusion increases eligible volume and reduces payer segmentation, accelerating uptake.

4) What determines whether resmetirom becomes preferred therapy among NASH competitors?
Relative efficacy on fibrosis and NASH resolution, coupled with a manageable safety profile and payer-friendly access criteria.

5) How do diagnostic and staging practices influence NASH drug commercialization?
Underdiagnosis reduces total addressable demand, while staging access determines how quickly eligible patients enter treatment pathways.

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References (APA)

1. (No sources were provided in the prompt.)