JRCT ID: jRCT2051240175
Registered date:31/10/2024
A Phase IIb Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of AZD6234 in Participants Living With Obesity or Overweight With Comorbidity
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | Obesity |
Date of first enrollment | 22/11/2024 |
Target sample size | 21 |
Countries of recruitment | US,Japan,Canada,Japan,Australia,Japan,United Kingdom,Japan,Poland,Japan |
Study type | Interventional |
Intervention(s) | Drug : AZD6234 Drug : Placebo |
Outcome(s)
Primary Outcome | - Percent change in body weight from baseline to week 26 - Weight loss 5% or more from baseline weight to week 26 |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | >= 18age old |
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Age maximum | <= 75age old |
Gender | Both |
Include criteria | - Adults 18 years of age or more - BMI of (a) 30 kg/m2 or more, or (b) 27kg/m2 or more and have a current diagnosis of at least 1 weight-related comorbidities (treated or untreated) - A stable body weight for 3 months prior to Screening (+-5% body weight change) |
Exclude criteria | - Have obesity induced by other endocrine disorders, such as Cushing's syndrome or Prader-Willi syndrome - Has received prescription or non-prescription medication for weight loss within the last 3 months prior to Screening - Previous or planned (within study period) bariatric surgery or fitting of a weight loss device (eg, gastric balloon or duodenal barrier) - History of type 1 diabetes mellitus or T2DM |
Related Information
Primary Sponsor | Ageishi Yuji |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | NCT06595238 |
Contact
Public contact | |
Name | Yuji Ageishi |
Address | 3-1, Ofuka-cho, Kita-ku, Osaka-shi, Osaka Osaka Japan 530-0011 |
Telephone | +81-6-4802-3533 |
RD-clinical-information-Japan@astrazeneca.com | |
Affiliation | Astrazeneka K.K |
Scientific contact | |
Name | Yuji Ageishi |
Address | 3-1, Ofuka-cho, Kita-ku, Osaka-shi, Osaka Osaka Japan 530-0011 |
Telephone | +81-6-4802-3533 |
RD-clinical-information-Japan@astrazeneca.com | |
Affiliation | Astrazeneka K.K |