CompletedPhase 2

A Study to Evaluate DD01 in Overweight/Obese Subjects With MASLD/MASH

United States67 participantsStarted 2024-06-13

Plain-language summary

This is a Phase 2 Study to evaluate the effect of DD01 treatment in overweight/obese patients with metabolic dysfunction-associated steatotic liver disease (MASLD)/metabolic dysfunction-associated steatohepatitis (MASH).

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. Biopsy proven MASH obtained during Screening which confirms the presence of MASH characterized by a NAS ≥4 with at least 1 in each component (steatosis, ballooning, and lobular inflammation) and fibrosis stage F1 to F3. A historical biopsy obtained within 6 months may be acceptable OR
✓. Meets at least 2 additional metabolic syndrome factors

What they're measuring

Proportion of subjects who achieve at least 30% liver fat reduction measured by MRI-PDFF

Timeframe: 12 weeks

Trial details

NCT IDNCT06410924

SponsorNeuraly, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-05-20

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