Levothyroxine Sodium in Fibrosis, Liver: NCT05526144 Clinical Landscape Report 2026

15 October 2026
9 min read

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This Clinical Landscape Report was built with PatSnap Life Sciences MCP workflows. Clinical Trials MCP supplies protocol and result records, Drug & Asset MCP adds asset context, and Company & Deal Intelligence MCP resolves sponsor background. Use the same structured MCP building blocks in your research workflow.

Data snapshot: 15 October 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.

Phase 2

Clinical phase

Recruiting

Recruitment status

not reported

Planned enrollment

2029-12-31

Primary-completion proxy

Executive view

NCT05526144 evaluates Levothyroxine Sodium in Fibrosis, Liver. The disclosed sponsor is VA Office of Research and Development, the design is Interventional, and the geographic footprint is United States. The first listed primary endpoint is Improvement in Nonalcoholic fatty liver disease activity score (NAS) by 2 points, assessed over 12 months.

The key landscape question is whether this protocol can generate a clinically interpretable signal relative to nearby programs. Phase alone is not a measure of evidence quality. Endpoint relevance, comparator choice, masking, enrollment feasibility, patient selection, country coverage and follow-up must be considered together.

PatSnap MCP Servers make this assessment reproducible by keeping protocol facts, result evidence, asset attributes and sponsor identity in separate structured calls.

How the MCP evidence stack was assembled

Clinical Trials MCP clinical_trial_fetch retrieved the design, outcomes, phase, status, enrollment, sponsor, countries and timing for NCT05526144 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Fibrosis, Liver landscape. Drug & Asset MCP drug_fetch was queried for Levothyroxine Sodium, while Company & Deal Intelligence MCP organization_fetch was queried for VA Office of Research and Development.

This separation reduces a common diligence error: treating a registry label, a company description or a result excerpt as if each represented the complete evidence package. Explore the source workflow at the PatSnap MCP marketplace.

Trial landscape table

TrialAsset / interventionPhase / statusSponsorGeographyPrimary endpointReadout proxy
NCT05526144Levothyroxine SodiumPhase 2 / RecruitingVA Office of Research and DevelopmentUnited StatesImprovement in Nonalcoholic fatty liver disease activity score (NAS) by 2 points
12 months
2029-12-31
NCT06365580Kylo-0603Phase 1 / CompletedKylonova (Xiamen) Biopharma Co., Ltd.Chinaincidence of adverse events
up to 3 weeks
2024-08-16
NCT06355310EmpagliflozinPhase 2 / RecruitingAnn & Robert H. Lurie Children's Hospital of ChicagoUnited StatesHepatic Fat
26-Weeks
2028-01-01
NCT06342947ALG-055009Phase 2 / CompletedAligos Therapeutics, Inc.United StatesPercent relative change from baseline in liver fat content
12 weeks
2024-08-19
NCT06322628VSA-006Phase 2 / Active, not recruitingVisirna Therapeutics HK LimitedChinaPercentage of Participants Achieving ≥ 1 Stage Improvement in Histological Fibrosis with no Worsening of NASH
At week 52
2026-07-01

The table aligns endpoints, sponsors, phases, geographies and readout proxies. It is descriptive, not a head-to-head efficacy comparison. Differences in population, baseline risk, intervention schedule and follow-up can dominate apparent cross-trial differences.

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Protocol design and endpoint interpretation

NCT05526144 is a Phase 2, recruiting study with not reported planned participants. Allocation is Randomized, masking is Triple, and the intervention model is Parallel Assignment.

The primary endpoint is “Improvement in Nonalcoholic fatty liver disease activity score (NAS) by 2 points” over “12 months.” The retrieved endpoint description is: To examine the efficacy of daily low dose Synthroid, using a dose-titration strategy based on serum thyroid stimulating hormone (TSH), on the histological progression of nonalcoholic steatohepatitis (NASH) in Veterans with normal serum TSH levels and biopsy-proven NASH, and to compare the treated patients with Veterans on placebo. Liver biopsies will be obtained at baseline (Week 0) and at end of treatment (Week 52). Nonalcoholic fatty liver disease activity score (NAS) will be assessed in baseline and post treatment liver biopsies and improvement in NAS will be compared between study group on active treatment a….

Interpretation should test whether the endpoint captures a clinically meaningful change, whether its time horizon matches the proposed biology, and whether treatment discontinuation or missing data can bias the estimate. The planned enrollment of not reported should be assessed against expected effect size, event frequency, multiplicity, subgroup plans and attrition.

No named control drug was returned in the protocol field set. A placebo comparator can strengthen internal efficacy assessment, while an active comparator may better test clinical differentiation. Single-arm and open-label programs require greater weight on objective outcomes, independent assessment and external benchmarks.

Indexed readouts in the surrounding landscape

0 recent result records were selected as contextual evidence for Fibrosis, Liver. These records do not establish direct evidence for NCT05526144 unless the registration number matches.

Indexed evidence status

No directly comparable result record was retrieved for this disease query. This is a monitoring gap, not evidence of absence.

Result fields should be reconciled with the source record before quantitative comparison. Population definitions, analysis sets, dose cohorts, estimands, confidence intervals, rescue therapy and follow-up can materially change the meaning of a numerical endpoint. Clinical Trials MCP supports repeatable refreshes as result records change.

Asset and sponsor context

Levothyroxine Sodium is indexed as Small molecule drug with THR biology and a global stage of Approved. The asset profile lists AbbVie, Inc. as an originator or developer.

VA Office of Research and Development is indexed in an unreported country with the website https://www.research.va.gov. The organization record is used to resolve sponsor identity. The record lists 5 development-stage drug assets.

For execution diligence, monitor sponsor ownership, collaborator additions, site expansion, protocol amendments and enrollment revisions. A change in ownership or geography can alter operational confidence as well as the commercial meaning of a future readout.

Development white space

  1. Endpoint white space. Determine whether a more patient-relevant outcome, longer durability window or blinded central assessment would resolve uncertainty left by the current endpoint.
  2. Population white space. Test biomarker-defined, treatment-line or risk-stratified subgroups where effect size and unmet need could be clearer.
  3. Comparator white space. Identify whether the study can support differentiation against the current standard of care rather than only activity against baseline or placebo.
  4. Geographic white space. Assess whether the disclosed footprint supports recruitment, regulatory transferability and commercial generalizability.
  5. Sequencing white space. Clarify whether Levothyroxine Sodium is intended for monotherapy, combination, maintenance, rescue or an earlier treatment line.

White space should be framed as an unanswered development question, not merely an unoccupied mechanism label. A credible program closes a measurable clinical uncertainty with a design that can be executed and interpreted.

Strategic implications and next readouts

For sponsors, the endpoint hierarchy, safety window, enrollment pace and protocol amendment history should all support the same target product profile. Advancement criteria should be set before the readout and tied to clinical effect, uncertainty, tolerability and operational feasibility.

For business-development teams, differentiation may come from a sharper population, stronger comparator, more durable benefit, simpler delivery or clearer sequencing role. For investors, the central risk is evidence quality relative to time and capital, not the phase label in isolation.

Track recruitment status, enrollment changes, primary-completion timing, endpoint revisions, new result records, sponsor ownership and collaborator changes. Re-run the PatSnap MCP workflow when a surrogate becomes a clinical outcome, a single-country study expands, the comparator changes or a new result materially shifts the competitive benchmark.

Source trail and bottom line

Anchor trial: NCT05526144
Protocol source: https://clinicaltrials.gov/study/NCT05526144
MCP sources: Clinical Trials MCP (clinical_trial_fetch and clinical_trial_result_fetch); Drug & Asset MCP (drug_fetch); Company & Deal Intelligence MCP (organization_fetch).
Data snapshot: 15 October 2026.

Levothyroxine Sodium in Fibrosis, Liver is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes Improvement in Nonalcoholic fatty liver disease activity score (NAS) by 2 points and 2029-12-31 the leading decision points.

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