Study S000213

A Phase 3, Randomized, Double-blinded Study to Evaluate the Efficacy and Safety of HRS-7535 Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise (OUTSTAND-1)

Included trial: extracted data ClinicalTrials.gov record

Registration

Registration: NCT06672172
Acronym: OUTSTAND-1
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: DOUBLE
Status: COMPLETED
Enrollment: 284
Start: 2024-09-25
Primary completion: 2025-11-13
Lead sponsor: Shandong Suncadia Medicine Co., Ltd.
Conditions: Type 2 Diabetes
Interventions: DRUG:HRS-7535 tablet; DRUG:HRS-7535 placebo tablet
Results posted: FALSE
Individual participant data sharing: UNDECIDED

Registered primary outcomes

Change from baseline in HbA1c at 32 weeks of treatment [at 32 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
R0011607	Oral small-molecule GLP-1 receptor agonist safiglipron in early type 2 diabetes: a randomized, double-blind, placebo-controlled trial. Yu M, Nature medicine	2026	Randomized trial	PMID 42811187 DOI	cites ClinicalTrials.gov:NCT06672172; registry reference DERIVED:42811187