A weight loss study evaluating subcutaneous treatment with AZD9550 and AZD6234 in combination against placebo or each of the drugs alone - ASCEND
Study identifier:D8460C00004
ClinicalTrials.gov identifier:NCT06862791
EudraCT identifier:N/A
CTIS identifier:2024-516176-15-00
Recruiting
Official Title
A Phase IIb Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of Co-administration of AZD9550 and AZD6234 in Participants Living With Obesity or Overweight with Co-morbidity (ASCEND)
Medical condition
Obesity or Overweight
Phase
Phase 2
Healthy volunteers
No
Study drug
AZD9550, AZD6234, Placebo comparator
Sex
All
Estimated Enrollment
360
Study type
Interventional
Age
18 Years - 75 Years
Date
Study Start Date: 18 Feb 2025
Estimated Primary Completion Date: 18 Jun 2026
Estimated Study Completion Date: 18 Jun 2026
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Mar 2025 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1 AZD9550 low dose + AZD6234 low dose or placebos | Drug: AZD9550 IMP injected subcutaneous, once weekly. Unit dose strength as per CSP Drug: AZD6234 IMP injected subcutaneous, once weekly. Unit dose strength as per CSP. Drug: Placebo comparator Placebo matching IMP dose injected subcutaneously, once weekly. |
| Experimental: Arm 2 AZD9550 medium dose + AZD6234 medium dose or placebos | Drug: AZD9550 IMP injected subcutaneous, once weekly. Unit dose strength as per CSP Drug: AZD6234 IMP injected subcutaneous, once weekly. Unit dose strength as per CSP. Drug: Placebo comparator Placebo matching IMP dose injected subcutaneously, once weekly. |
| Experimental: Arm 3 AZD9550 high dose + AZD6234 high dose or placebos | Drug: AZD9550 IMP injected subcutaneous, once weekly. Unit dose strength as per CSP Drug: AZD6234 IMP injected subcutaneous, once weekly. Unit dose strength as per CSP. Drug: Placebo comparator Placebo matching IMP dose injected subcutaneously, once weekly. |
| Experimental: Arm 4 AZD9550 low dose + AZD6234 medium dose or placebos | Drug: AZD9550 IMP injected subcutaneous, once weekly. Unit dose strength as per CSP Drug: AZD6234 IMP injected subcutaneous, once weekly. Unit dose strength as per CSP. Drug: Placebo comparator Placebo matching IMP dose injected subcutaneously, once weekly. |
| Experimental: Arm 5 AZD9550 medium dose + AZD6234 low dose or placebos | Drug: AZD9550 IMP injected subcutaneous, once weekly. Unit dose strength as per CSP Drug: AZD6234 IMP injected subcutaneous, once weekly. Unit dose strength as per CSP. Drug: Placebo comparator Placebo matching IMP dose injected subcutaneously, once weekly. |
| Experimental: Arm 6 AZD9550 high dose + AZD6234 medium dose or placebos | Drug: AZD9550 IMP injected subcutaneous, once weekly. Unit dose strength as per CSP Drug: AZD6234 IMP injected subcutaneous, once weekly. Unit dose strength as per CSP. Drug: Placebo comparator Placebo matching IMP dose injected subcutaneously, once weekly. |
| Experimental: Arm 7 AZD9550 medium dose + AZD6234 high dose or placebos | Drug: AZD9550 IMP injected subcutaneous, once weekly. Unit dose strength as per CSP Drug: AZD6234 IMP injected subcutaneous, once weekly. Unit dose strength as per CSP. Drug: Placebo comparator Placebo matching IMP dose injected subcutaneously, once weekly. |
| Experimental: Arm 8 AZD9550 high dose or placebo | Drug: AZD9550 IMP injected subcutaneous, once weekly. Unit dose strength as per CSP Drug: Placebo comparator Placebo matching IMP dose injected subcutaneously, once weekly. |
| Experimental: Arm 9 AZD6234 high dose or placebo | Drug: AZD6234 IMP injected subcutaneous, once weekly. Unit dose strength as per CSP. Drug: Placebo comparator Placebo matching IMP dose injected subcutaneously, once weekly. |
