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
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1 Participants will receive xx mg once daily dose of AZD5004 | Drug: AZD5004 AZD5004 film-coated tablet, once daily during 26 weeks |
| Experimental: Arm 2 Participants will receive xx mg once daily dose of AZD5004 | Drug: AZD5004 AZD5004 film-coated tablet, once daily during 26 weeks |
| Experimental: Arm 3 Participants will receive xx mg once daily dose of AZD5004 | Drug: AZD5004 AZD5004 film-coated tablet, once daily during 26 weeks |
| Experimental: Arm 4 Participants will receive xx mg once daily dose of AZD5004 | Drug: AZD5004 AZD5004 film-coated tablet, once daily during 26 weeks |
| Experimental: Arm 5 Participants will receive xx mg once daily dose of AZD5004 | Drug: AZD5004 AZD5004 film-coated tablet, once daily during 26 weeks |
| Experimental: Arm 6 Participants will receive xx mg once daily dose of AZD5004 | Drug: AZD5004 AZD5004 film-coated tablet, once daily during 26 weeks |
| Active Comparator: Arm 7 Participants will receive once daily dose of Semaglutide as active comparator | Drug: Semaglutide 3-14 mg tablets of Semaglutide Other Name: Rybelsus |
| Placebo Comparator: Arm 8 Participants will receive matching placebo for each AZD5004 arm | Drug: Placebo (placebo matching AZD5004 film-coated tablet) Placebo film-coated tablet (matching AZD5004) |
