Efficacy, Safety, and Tolerability of Once Daily Oral Administration of AZD5004 versus Placebo for 26 Weeks in Adults with Type 2 Diabetes Mellitus. - SOLSTICE

Study identifier:D7261C00001

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:2024-512562-34-00

Will Be Recruiting

Official Title

A Phase IIb, Randomized, Double-blind, Placebo-controlled and Open-label Active Comparator Study to Evaluate the Efficacy, Safety, and Tolerability of AZD5004 in Adults with Type 2 Diabetes Mellitus.

Medical condition

Diabetes Mellitus, Type 2

Phase

Phase 2

Healthy volunteers

No

Study drug

Placebo (placebo matching AZD5004 film-coated tablet), AZD5004, Semaglutide

Sex

All

Estimated Enrollment

384

Study type

Interventional

Age

n/a - n/a

Date

Study Start Date: 08 Oct 2024
Estimated Primary Completion Date: 23 Dec 2025
Estimated Study Completion Date: 23 Dec 2025

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Aug 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria