The metabolic population, screened to fibrosis-stage eligibility, confirmed before your site sees them.

Metabolic Dysfunction-Associated Steatohepatitis (MASH) recruitment is a diagnosis-confirmation and procedure-burden problem sitting on top of a metabolic-reach problem. Leapcure has solved both halves on completed adjacent trials: reaching a diabetic population against strict biomarkers, and recruiting a biopsy-confirmed, treatment-naive population with diagnosis verified before referral.

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570
Qualified referrals delivered to sites
completed Phase 2 diabetic kidney disease trial (metabolic)
5,469
Referred through strict biomarker eligibility
completed Phase 2 diabetic (metabolic) population
657
Specialist physicians engaged
completed respiratory programs; hepatology/GI pathway to be built
50+
Countries reached, multilingual
cross-portfolio recruitment capability

Understanding MASH as a Clinical Trial Indication

MASH, metabolic dysfunction-associated steatohepatitis and formerly called NASH, is a progressive form of fatty liver disease in which fat accumulation drives inflammation and liver scarring. It is a leading and rising driver of advanced liver disease, closely tied to obesity and Type 2 diabetes, and it sits inside the large metabolic population those conditions define. (This epidemiology is third-party context and is being confirmed and dated with Medical before production go-live.)

For sponsors, MASH recruitment is deceptively hard. The patients sit inside the huge obesity and Type 2 diabetes metabolic population, but trials gate on fibrosis stage, typically F2 to F3, require FibroScan, MRI-PDFF, or liver biopsy confirmation, exclude other liver disease and alcohol, and often require treatment-naive status. It is a diagnosis-confirmation and procedure-burden problem, with a narrow-eligibility core, sitting on top of a metabolic-reach problem. Reaching the population is not enough; confirming fibrosis-stage eligibility before a site is burdened is the real work.

Leapcure has solved each half of the MASH problem on completed adjacent programs. Pillar one, metabolic reach: on a completed Phase 2 diabetic kidney disease trial we recruited a diabetic population against strict UACR and eGFR biomarker eligibility, 5,469 referred and 570 qualified to sites. Pillar two, biopsy-confirmed, treatment-naive, narrow eligibility: across two completed Phase 2 IPF studies we confirmed diagnosis before referral, HRCT and biopsy-validated when imaging was indeterminate, recruited a treatment-naive population, and ran screen-fail below the study average in an imaging and procedure-heavy indication. We also engaged 657 pulmonologists on those programs, proof we build specialist-physician referral pathways, with a hepatology and GI equivalent to be built. Each figure is labeled to its source indication, and our IPF work is presented as a procedure and eligibility analog.

The Challenge

MASH is a narrow, procedure-confirmed eligibility core sitting inside a huge metabolic population. Both problems have to be solved at once.

A narrow, fibrosis-stage eligibility core

MASH trials gate on fibrosis stage, typically F2 to F3, and require FibroScan, MRI-PDFF, or liver biopsy confirmation while excluding other liver disease and alcohol. Sending unconfirmed patients to sites burns biopsy and imaging slots and inflates screen fails.

Across two completed Phase 2 IPF studies, a biopsy-confirmed indication, Leapcure confirmed diagnosis before referral and ran screen-fail below the study average. A procedure and eligibility analog.

Treatment-naive status must be verified

Many MASH protocols require treatment-naive patients, so prior-therapy history has to be confirmed before referral rather than discovered at the site. That verification is its own recruiting task.

On completed Phase 2 IPF studies Leapcure recruited an antifibrotic-naive population and verified prior-therapy history before referral, the same rigor MASH naive requirements demand.

The patients sit inside a huge metabolic population

MASH overlaps heavily with obesity and Type 2 diabetes, so finding candidates means reaching and filtering a very large metabolic-comorbid population, not a neatly defined disease cohort.

On a completed Phase 2 diabetic kidney disease trial Leapcure referred 5,469 patients against strict biomarkers and delivered 570 qualified to sites, proof we reach and filter the metabolic-comorbid population.

Procedure burden and specialist pathways slow enrollment

FibroScan, MRI, and biopsy visits are demanding, and referrals flow through hepatology and GI specialists. Recruitment that ignores procedure burden and specialist pathways produces patients who drop off before confirmation.

On completed respiratory programs Leapcure managed a high procedure and visit burden with Patient Success support and engaged 657 specialist physicians (pulmonologists), proof we build specialist referral pathways; a hepatology/GI equivalent is to be built.

Three steps. One strategy built for your MASH trial.

Leapcure pairs the metabolic reach it proved on diabetic-population trials with the diagnosis-confirmation discipline it proved on a biopsy-confirmed indication, applied to MASH.

1

Reach the metabolic population MASH sits inside

We reach the obesity and Type 2 diabetes comorbid population through advocacy-led outreach, precision digital, and multilingual campaigns, mapped to your fibrosis-stage eligibility and site geographies. This is the metabolic reach proven on a completed diabetic-population trial.

2

Confirm diagnosis and eligibility before referral

Every patient is pre-screened before a site sees them. On a completed biopsy-confirmed indication we confirmed diagnosis before referral and ran screen-fail below the study average. For MASH that means screening toward FibroScan, MRI-PDFF, or biopsy-eligible, treatment-naive candidates so sites are not burdened with unconfirmed patients.

3

Manage procedure burden and build specialist pathways

A high-touch Patient Success team supports patients through a demanding procedure and visit schedule, and we build the specialist-physician referral pathways MASH requires. We engaged 657 pulmonologists on completed programs; the hepatology and GI equivalent is built the same way.

Both halves of the MASH problem, solved on completed adjacent trials.

Challenge Context

Our experience

Completed metabolic-population recruitment against strict biomarkers, and completed recruitment of a biopsy-confirmed, treatment-naive population with diagnosis verified before referral.

Source work (adjacent, completed)

A completed Phase 2 diabetic kidney disease trial (metabolic reach) and two completed Phase 2 IPF studies (biopsy-confirmed, treatment-naive eligibility analog).

Why it applies to MASH

MASH is a metabolic-population problem wrapped in a procedure-confirmed, narrow-eligibility core. The DKD program proves the metabolic reach; the IPF programs prove diagnosis confirmation, treatment-naive recruitment, and procedure-burden management. Together they map almost one to one onto MASH.

Results & Metrics

Diagnosis confirmation (completed)

Across two completed Phase 2 IPF studies, diagnosis confirmed before referral and screen-fail below the study average in an imaging and procedure-heavy indication. A site investigator noted this confirmation is a step others skip.

Metabolic reach (completed)

On a completed Phase 2 diabetic kidney disease trial, 5,469 patients referred against strict UACR and eGFR biomarkers and 570 qualified referrals delivered to sites.

Specialist pathways and pre-registry (completed)

657 specialist physicians (pulmonologists) engaged, and a pre-registry approach where 3 of the first 4 enrolled patients came from Leapcure and first screening occurred 21 days after launch on a Phase 2a.

Why it applies to MASH

Confirming fibrosis-stage eligibility before referral, verifying treatment-naive status, reaching the metabolic-comorbid population, and building specialist pathways are exactly what a MASH protocol needs.

Four channels. Proven on adjacent trials. Built for MASH.

Leapcure reaches the metabolic population, confirms fibrosis-stage eligibility before referral, manages procedure burden, and makes your trial retrievable to the AI engines patients now use.

Metabolic Population Reach

  • •We reach the obesity and Type 2 diabetes comorbid population MASH sits inside, through advocacy-led outreach and precision digital across 40+ cross-portfolio partnerships.
  • •Liver-specific advocacy partners are being confirmed by Marketing and are not named on this page until brand-approved, so advocacy appears here only as a cross-portfolio count.
  • •Multilingual campaigns support diverse, multinational MASH enrollment.

Diagnosis and Eligibility Confirmation

  • •Every referral is pre-screened before a site sees the patient, proven on a completed biopsy-confirmed indication where diagnosis was verified before referral.
  • •For MASH that means screening toward FibroScan, MRI-PDFF, or biopsy-eligible, treatment-naive candidates and verifying prior-therapy history.
  • •Sites receive confirmed, documentation-ready patients, protecting scarce biopsy and imaging slots.

Procedure-Burden and Specialist Pathways

  • •A high-touch Patient Success team supports patients through a demanding procedure and visit schedule from first contact to enrollment.
  • •We build specialist-physician referral pathways; we engaged 657 pulmonologists on completed programs and build the hepatology and GI equivalent the same way.
  • •This keeps procedure-heavy candidates engaged through confirmation rather than dropping off.

Answer-Engine and AI-Search Visibility

  • •MASH patients increasingly ask ChatGPT, Perplexity, and Google's AI Overview which trials they may be eligible for. We make your trial's information genuinely retrievable for those engines.
  • •We do this with crawlable, factually rich content, cited sources, and presence in the advocacy and ClinicalTrials.gov sources AI engines actually cite, not schema tricks or content written for machines.
  • •This puts your MASH study where high-intent metabolic and liver patients are already searching.

Living with MASH or fatty liver disease? A clinical trial may be an option.

If you are living with MASH, also called NASH or fatty liver disease, a clinical trial may offer access to investigational treatments alongside your regular care, never instead of it. We know MASH is often managed alongside diabetes and weight, and that eligibility can involve scans or a liver biopsy. Leapcure's team explains what a trial involves, answers your questions honestly, and supports you through any procedures at your pace.

See if a MASH trial may be right for you
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MASH is a metabolic-population problem wrapped in a biopsy-confirmed eligibility core, and Leapcure has solved both halves on completed adjacent trials: metabolic reach and biomarker filtering on a diabetic kidney disease Phase 2, and diagnosis-confirmed, treatment-naive recruitment with screen-fail below study average on two Phase 2 IPF studies. We map that experience directly onto your MASH protocol. Talk to our metabolic team about your active or upcoming MASH study.

Talk to our metabolic team