Clinical trial · ClinicalTrials.gov
A Study to Evaluate Survodutide in Participants With Non-alcoholic Steatohepatitis (NASH)
NCT05649174
Trial identity
- Registry
- ClinicalTrials.gov
- Registry ID
- NCT05649174
- Phase
- Phase 2
- Design
- Interventional
- Allocation
- Randomized
- Masking
- Double-blind
- Overall status
- Active, not recruiting
- Result status
- none
Sponsors & collaborators
- Sponsor
- Boehringer Ingelheim
- Collaborator
- Zealand Pharma
Intervention assets
Arms
| Arm | Intervention | Enrollment |
|---|---|---|
| Survodutide 2.4 mg | survodutide 2.4 mg once weekly | — |
| Survodutide 4.8 mg | survodutide 4.8 mg once weekly | — |
| Survodutide 6.0 mg | survodutide 6.0 mg once weekly | — |
| Placebo | placebo once weekly | — |
Population & enrollment
- Population summary
- Adults with biopsy-confirmed NASH/MASH and fibrosis.
- Eligibility summary
- Histologic NASH with F1-F3 fibrosis.
- Planned enrollment
- 250
- Actual enrollment
- 250
Endpoints
- Primary endpoint
Histologic resolution of NASH without worsening of fibrosis
- Secondary endpoints
Fibrosis improvement
ALT reduction
Dates
- Start date
- Nov 3, 2022
- Primary completion
- Jun 1, 2025
- Completion date
- Dec 1, 2025
- Last synced
- Aug 15, 2024
Locations
- Multiple countries
Plain-language interpretation
A Study to Evaluate Survodutide in Participants With Non-alcoholic Steatohepatitis (NASH) is a Phase 2 Interventional sponsored by Boehringer Ingelheim. It is evaluating Survodutide in Adults with biopsy-confirmed NASH/MASH and fibrosis.. The primary endpoint is Histologic resolution of NASH without worsening of fibrosis.
Registry disclaimer: Information is derived from public registry records and may lag behind the official source. Always verify against ClinicalTrials.gov.
Sources
- registryprimary record
Phase 2 NASH trial of survodutide in adults with MASH
Boehringer Ingelheim International GmbH · ClinicalTrials.gov · Nov 3, 2022 · NCT05649174