Study S003320

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Treatment With DD01 for 48 Weeks in Overweight/Obese Subjects With MASLD/MASH

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

ClinicalTrials.gov record

Registration

Registration: NCT06410924
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE2
Masking: TRIPLE
Status: COMPLETED
Enrollment: 67
Start: 2024-06-13
Primary completion: 2025-05-20
Lead sponsor: Neuraly, Inc.
Conditions: NAFLD; NASH
Interventions: DRUG:DD01; DRUG:Placebo
Results posted: FALSE

Registered primary outcomes

Proportion of subjects who achieve at least 30% liver fat reduction measured by MRI-PDFF [12 weeks]

Linked records (1)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0029422	The glucagon and GLP-1 receptor dual agonist DD01 for metabolic dysfunction-associated steatotic liver disease and steatohepatitis (DD01-DN-02): 12-week results from a randomised, double-blind, multicentre, placebo-controlled, phase 2 trial. Noureddin M, The lancet. Gastroenterology & hepatology	2026	Randomized trial	PMID 42480572 DOI	cites ClinicalTrials.gov:NCT06410924; registry reference DERIVED:42480572