Study identifier:D7261C00001
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:2024-512562-34-00
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.
Diabetes Mellitus, Type 2
Phase 2
No
Placebo (placebo matching AZD5004 film-coated tablet), AZD5004, Semaglutide
All
384
Interventional
n/a - n/a
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Aug 2024 by AstraZeneca
AstraZeneca
-
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) |