# This Study Evaluates the Safety, Target Engagement, and Preliminary Efficacy of Galunisertib (TGF-βR1/ALK5 Inhibitor)Combined With Nerandomilast (PDE4 Inhibitor) in GREM2-positive ALS, a Biomarker-defined Subgroup Hypothesized to Reflect Heightened TGF-β/SMAD-driven Astrocytic and Fibrotic Signaling

> **NCT07321860** · PHASE2,PHASE3 · NOT_YET_RECRUITING · sponsor: **Gipfel Life Sciences GmbH** · enrollment: 60 (estimated)

## Conditions studied

- ALS (Amyotrophic Lateral Sclerosis)

## Interventions

- **DRUG:** Galunisertib + Nerandomilast Combination

## Key facts

- **NCT ID:** NCT07321860
- **Lead sponsor:** Gipfel Life Sciences GmbH
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2,PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** NOT_YET_RECRUITING
- **Start date:** 2026-06-30
- **Primary completion:** 2027-06-30
- **Final completion:** 2028-01-01
- **Target enrollment:** 60 (ESTIMATED)
- **Last updated:** 2026-01-07


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT07321860

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT07321860, "This Study Evaluates the Safety, Target Engagement, and Preliminary Efficacy of Galunisertib (TGF-βR1/ALK5 Inhibitor)Combined With Nerandomilast (PDE4 Inhibitor) in GREM2-positive ALS, a Biomarker-defined Subgroup Hypothesized to Reflect Heightened TGF-β/SMAD-driven Astrocytic and Fibrotic Signaling". Retrieved via AI Analytics 2026-05-29 from https://api.ai-analytics.org/clinical/NCT07321860. Licensed CC0.

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