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JAPANESE
国立保健医療科学院
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
Health condition(s) or Problem(s) studiedObesity
Date of first enrollment22/11/2024
Target sample size21
Countries of recruitmentUS,Japan,Canada,Japan,Australia,Japan,United Kingdom,Japan,Poland,Japan
Study typeInterventional
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
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximum<= 75age old
GenderBoth
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

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
E-mail 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
E-mail RD-clinical-information-Japan@astrazeneca.com
Affiliation Astrazeneka K.K