Study S001918

Multicentre, Randomised, Double-blind, Placebo-controlled, 48-week, Phase III Trial to Evaluate the Efficacy and Safety of Survodutide Administered Subcutaneously in Participants With Overweight or Obesity and Presumed or Confirmed Nonalcoholic Steatohepatitis (NASH)

Included trial: extracted data ClinicalTrials.gov record

Registration

Registration: NCT06309992
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 218
Start: 2024-04-02
Primary completion: 2025-10-09
Lead sponsor: Boehringer Ingelheim
Conditions: Obesity; Non-Alcoholic SteatoHepatitis (NASH)
Interventions: COMBINATION_PRODUCT:Survodutide; COMBINATION_PRODUCT:Placebo
Results posted: FALSE
Individual participant data sharing: YES
Secondary identifiers: REGISTRY:2023-505303-23-00; REGISTRY:U1111-1299-9925; NIH:2023

Registered primary outcomes

Relative reduction in liver fat content of at least 30% from baseline to Week 48 (yes/no) assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF) [%] [at baseline, at week 48]
Relative change (%) in body weight [kg] from baseline to Week 48 [at baseline, at week 48]

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