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

JRCT ID: jRCT2051240175

Registered date:31/10/2024

Basic Information

• Recruitment status: Pending
• 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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• 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
• Secondary ID(s): NCT06595238