Study identifier:D7260C00001
ClinicalTrials.gov identifier:NCT06579092
EudraCT identifier:N/A
CTIS identifier:2024-513691-18-00
A Phase IIb Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of AZD5004 in Participants Living with Obesity or Overweight with Comorbidity
Obesity or Overweight
Phase 2
No
AZD5004, Placebo
All
310
Interventional
18 Years - n/a
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Mar 2025 by AstraZeneca
AstraZeneca
-
A Phase IIb, global, randomized, parallel-group, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of AZD5004 compared with placebo, given once daily as an oral tablet(s) for 36 weeks, in male and female participants at least 18 years of age who are living with obesity (body mass index [BMI] ≥ 30 kg/m2), or overweight (BMI ≥ 27 kg/m2) who have at least 1 weight-related comorbidity
This is a Phase IIb, global, randomized, parallel-group, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of 5 doses of AZD5004 compared with placebo, given once daily as an oral tablet or tablets for a duration of 36 weeks, in adults aged 18 years and above, who are living with obesity (BMI ≥ 30 kg/m2), or overweight (BMI ≥ 27 kg/m2) and have at least 1 weight-related comorbidity (Hypertension, Dyslipidemia or hyperlipidemia, CV disease and/or Obstructive sleep apnea). Approximately 304 participants will be randomized in the study. The dual primary endpoints are percent change in body weight from baseline at 26 weeks and the proportion of participants with weight loss ≥ 5% of baseline weight at 26 weeks.
Location
Location
Dallas, TX, United States, 75230
Location
Durham, NC, United States, 27701
Location
Cincinnati, OH, United States, 45219
Location
Farmington Hills, MI, United States, 48334
Location
La Mesa, CA, United States, 91942
Location
North Charleston, South Carolina, United States, 29405
Location
Valparaiso, IN, United States, 46383
Location
Huntington Park, CA, United States, 90255
Arms | Assigned Interventions |
---|---|
Experimental: Arm 1 Active IMP | Drug: AZD5004 AZD5004 film-coated tablet once daily during 36 weeks Other Name: Active IMP |
Experimental: Arm 2 Active IMP | Drug: AZD5004 AZD5004 film-coated tablet once daily during 36 weeks Other Name: Active IMP |
Experimental: Arm 3 Active IMP | Drug: AZD5004 AZD5004 film-coated tablet once daily during 36 weeks Other Name: Active IMP |
Experimental: Arm 4 Active IMP | Drug: AZD5004 AZD5004 film-coated tablet once daily during 36 weeks Other Name: Active IMP |
Experimental: Arm 5 Active IMP | Drug: AZD5004 AZD5004 film-coated tablet once daily during 36 weeks Other Name: Active IMP |
Placebo Comparator: Arm 6 Matching placebo for each of the 5 active arms | Drug: Placebo Placebo matching AZD5004 film-coated tablet once daily during 36 weeks Other Name: Placebo |
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