Linafexor in Diabetes Mellitus, Type 2: NCT06492330 Clinical Landscape Report 2026

28 September 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: 28 September 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.

Not Applicable

Clinical phase

Completed

Recruitment status

62

Planned enrollment

2025-02-28

Primary-completion proxy

Executive view

NCT06492330 evaluates Linafexor in Diabetes Mellitus, Type 2. The disclosed sponsor is Shanghai Jiao Tong University School of Medicine, the design is Interventional, and the geographic footprint is China. The first listed primary endpoint is Percentage change in body weight relative to baseline, assessed over Baseline to 16 weeks.

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 NCT06492330 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Diabetes Mellitus, Type 2 landscape. Drug & Asset MCP drug_fetch was queried for Linafexor, while Company & Deal Intelligence MCP organization_fetch was queried for Shanghai Jiao Tong University School of Medicine.

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
NCT06492330LinafexorNot Applicable / CompletedShanghai Jiao Tong University School of MedicineChinaPercentage change in body weight relative to baseline
Baseline to 16 weeks
2025-02-28
NCT06716905NM-6606Phase 1 / CompletedXiamen Amoytop Biotech Co. Ltd.ChinaAdverse Event(AE)
SAD:Day1-8; MAD:Day1-22.
2025-09-22
NCT06705998BAR-502Phase 1 / CompletedBAR Pharmaceuticals s.r.l.SwitzerlandTreatment-emergent adverse events
PART A: Day-15/-2; Day-1 to Day4; Day 8; Day15 - PART B: Day-15/-2 to…
2026-06-03
NCT06692283DenifanstatPhase 3 / WithdrawnSagimet Biosciences, Inc.Geography not reportedPrimary Safety Outcome Measure: TEAEs
52 weeks
2026-06-01
NCT06677788Vitamin E NicotinicatePhase 2 / CompletedTanta UniversityEgyptChange in liver stiffness measurement (LSM) measured by fibroscan score
12 weeks following the end of treatment
2024-09-20

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

NCT06492330 is a Not Applicable, completed study with 62 planned participants. Allocation is Randomized, masking is Double, and the intervention model is Parallel Assignment.

The primary endpoint is “Percentage change in body weight relative to baseline” over “Baseline to 16 weeks.” The retrieved endpoint description is: Evaluate the percentage change in body weight relative to baseline after 16 weeks of treatment..

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 62 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

5 recent result records were selected as contextual evidence for Diabetes Mellitus, Type 2. These records do not establish direct evidence for NCT06492330 unless the registration number matches.

A Placebo-controlled, Proof-of-concept Study to Evaluate the Safety and Efficacy of Lanifibranor Alone and in Combination With the Sodium-glucose Transport Protein 2 (SGLT2) Inhib…

Phase 2; n=39; Absolute Change in HbA1c(Least Squares Mean) = 0.16 percentage of glycosylated hemoglobin (95% Confidence Interval, -0.32 to 0.63); Absolute Change in HbA1c(Least Squares Mean) = -1.11 percentage of glycosylated hemoglobin (95% Confidence Interval, -1.6 to -0.62) Source: https://clinicaltrials.gov/ct2/show/results/NCT05232071

Role of Lisinopril in Preventing The Progression of Non-Alcoholic Fatty Liver Disease (NAFLD): Relief-NAFLD

Phase 2; n=35; Pre-Treatment(Mean) = 48 ng/mL (Standard Deviation, 17) Source: https://clinicaltrials.gov/ct2/show/results/NCT04550481

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steato…

Phase 2; n=213; ADR = 10 Participants ; ADR = 8 Participants Source: https://clinicaltrials.gov/ct2/show/results/NCT05039450

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

Linafexor is indexed as Small molecule drug with FXR biology and a global stage of Phase 3. The asset profile lists Cascade Pharmaceuticals, Inc. as an originator or developer.

Shanghai Jiao Tong University School of Medicine is indexed in China with the website http://www.shsmu.edu.cn. Functions as a College/University The record lists 59 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 Linafexor 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: NCT06492330
Protocol source: https://clinicaltrials.gov/study/NCT06492330
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: 28 September 2026.

Linafexor in Diabetes Mellitus, Type 2 is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes Percentage change in body weight relative to baseline and 2025-02-28 the leading decision points.

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