Efficacy, Safety, and Tolerability of Once Daily Oral Administration of AZD5004 Versus Placebo for 26 Weeks in Adults With Type 2 Diabetes Mellitus.

Phase 2 Completed 406 enrolled AstraZeneca

RandomizedParallel-groupTriple-blindTreatment

Summary

This is a Phase IIb, randomised, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy, safety and tolerability of AZD5004 in adults with type 2 diabetes mellitus, compared to placebo and active comparator.

Timeline

Start: 2024-10-08
Primary completion: 2025-12-19
Completion: 2025-12-19

Publications

Aroda VR, Davies MJ, Maaske J, Millegard M, Juan VL, Aberle J, Ciudin A, McCrimmon RJ, Eklund O, Shih JL, Sjostrand M, Zarzuela D, Rosenstock J. Elecoglipron, an oral small molecule GLP-1 receptor agonist in adults with type 2 diabetes (SOLSTICE): a multicentre, phase 2b, randomised, placebo-controlled trial. Lancet. 2026 Jun 20;407(10547):2515-2527. doi: 10.1016/S0140-6736(26)00802-0. Epub 2026 Jun 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	AZD5004	Unknown	5 mg	Oral
Subject	AZD5004	Unknown	15 mg	Oral
Subject	AZD5004	Unknown	25 mg	Oral
Subject	AZD5004	Unknown	50 mg	Oral
Subject	AZD5004	Unknown	75 mg	Oral
Comparator	Semaglutide	Peptide	14 mg	Oral

Efficacy, Safety, and Tolerability of Once Daily Oral Administration of AZD5004 Versus Placebo for 26 Weeks in Adults With Type 2 Diabetes Mellitus.

Summary

Timeline

Publications

Drugs

Indications