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Source comparison

Tesamorelin Clinical Trials 2026 Comparison: Study Design and Endpoints

NCT05847293 Adults with MASLD, hepatic fat ≥10% by MRI-PDFF 52 weeks Absolute reduction in liver fat fraction at week 26 2mg SC daily VAT by MRI, ALT/AST, FibroScan liver stiffness, HOMA-IR Largest MASLD trial; histology substudy in biopsy-confirmed NASH subse

This comparison does not assign a generated winner or score.

  • NCT05847293
  • Adults with MASLD, hepatic fat ≥10% by MRI-PDFF
  • 52 weeks
  • Absolute reduction in liver fat fraction at week 26
  • 2mg SC daily
  • VAT by MRI, ALT/AST, FibroScan liver stiffness, HOMA-IR
  • Largest MASLD trial; histology substudy in biopsy-confirmed NASH subset (n=90). First to use 2023 AASLD nomenclature and diagnostic criteria.
  • NCT05921804
  • HIV-negative adults, abdominal obesity (WC ≥102/88 cm), prediabetes or insulin resistance
  • 36 weeks
  • Percent change in VAT (cm²) measured by single-slice L4-L5 MRI
  • Lipid panel, HbA1c, hs-CRP, SAT, lean mass by DEXA
  • Tests mechanism transferability outside HIV indication. Washout phase assesses durability. Prior studies show 60% VAT regain within 12 weeks post-discontinuation.
  • NCT05789432
  • Postmenopausal women, central adiposity, ASCVD risk ≥7.5%
  • 48 weeks
  • VAT reduction ≥15% from baseline at week 24
  • Lipid subfractions (ApoB, LDL-P), cIMT, lean mass, IGF-1 levels
  • Sex-stratified dosing analysis. Hypothesis: women require 12–16 weeks longer than men to achieve equivalent VAT reduction due to lower baseline GH and higher somatostatin tone.
  • NCT05654871
  • Adults with HIV, lipodystrophy, VAT/SAT ratio >1.2
  • 26 weeks
  • Change in trunk-to-limb fat ratio by DEXA
  • Patient-reported body image distress (BIDS-8 score), VAT, metabolic panel
  • Extension of original Egrifta approval studies. Evaluates patient-centered outcomes (body image, quality of life) alongside biomarkers. Addressing FDA emphasis on meaningful clinical benefit.
  • The comparison reveals a pattern: every tesamorelin clinical trial 2026 powered for VAT reduction treats it as primary or co-primary endpoint, but the clinically meaningful outcomes (fibrosis reversal, cardiovascular events, quality-of-life improvement) are relegated to secondary or exploratory status. This reflects current evidence limitations. We have robust proof that tesamorelin reduces VAT, moderate evidence it improves liver fat and lipid panels, and minimal long-term data on hard outcomes. The 52-week MASLD trial (NCT05847293) is the first designed to generate FDA-quality evidence for non-HIV indication expansion.