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Follistatin-344 Clinical Trials 2026: Study Design and Endpoint Comparison Table
Understanding how Follistatin-344 clinical trials 2026 differ in design and measurement strategy clarifies why this peptide may succeed where earlier programs failed. Duchenne Muscular Dystrophy (ages 5–12) NCT06382001 Phase II 84 participants 1 mg/kg, 2 mg/kg
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- Understanding how Follistatin-344 clinical trials 2026 differ in design and measurement strategy clarifies why this peptide may succeed where earlier programs failed.
- Duchenne Muscular Dystrophy (ages 5–12)
- NCT06382001
- Phase II
- 84 participants
- 1 mg/kg, 2 mg/kg, or 3 mg/kg subcutaneous weekly
- Change in North Star Ambulatory Assessment score at 48 weeks
- Quantitative MRI T2 relaxation time, serum CK, timed function tests (10-meter walk, 4-stair climb)
- 48 weeks
- NSAA is FDA-accepted; dose range tests therapeutic window vs safety margin
- Chronic Kidney Disease Sarcopenia (Stage 4–5 CKD)
- NCT06401203
- 140 participants
- 3 mg/kg subcutaneous weekly
- Change in appendicular lean mass index by DEXA at 24 weeks
- Handgrip strength, gait speed, serum myostatin and activin A levels, dialysis adequacy (Kt/V)
- 24 weeks
- Lean mass gain must correlate with function to meet regulatory bar; myostatin/activin biomarkers confirm mechanism
- Idiopathic Pulmonary Fibrosis
- NCT06411102
- 96 participants
- Change in forced vital capacity (FVC) at 52 weeks
- Histological collagen quantification, 6-minute walk distance, dyspnea score, serum activin A
- 52 weeks
- FVC is established IPF endpoint; collagen biopsy is mechanistic proof; activin A links to fibrosis pathway directly
- Metabolic Dysfunction (obesity with prediabetes)
- NCT06415204
- 60 participants
- 2 mg/kg subcutaneous weekly
- Change in HOMA-IR at 16 weeks
- Visceral adipose tissue volume by MRI, serum adiponectin, brown adipose tissue activity by PET-CT, body weight
- 16 weeks
- Exploratory trial testing non-muscle Follistatin-344 effects; HOMA-IR is insulin resistance gold standard
- Becker Muscular Dystrophy
- NCT06425005
- Phase I/II
- 36 participants
- Dose escalation: 0.5, 1, 2, 3 mg/kg subcutaneous weekly
- Safety and tolerability (adverse events, lab abnormalities)
- Muscle strength by dynamometry, lean mass by DEXA, muscle biopsy fiber diameter
- Safety-focused with strength as exploratory; Becker phenotype is milder than Duchenne, allowing adult enrollment