Effects of AZD5004 in adults who are living with obesity or overweight with at least 1 weight-related comorbidity

JRCT ID: jRCT2051240162

Registered date:16/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Obesity
• Date of first enrollment: 22/11/2024
• Target sample size: 19
• Countries of recruitment: US,Japan,Canada,Japan,Australia,Japan,Taiwan,Japan,United Kingdom,Japan,Germany,Japan
• Study type: Interventional

Intervention(s)

Drug: AZD5004
Drug: Placebo

Outcome(s)

Primary Outcome

- Percent change in body weight from baseline at Week 26
(Mesure Description: To determine whether AZD5004 is superior to placebo for weight loss)

- Proportion of participants with weight loss 5% or more from baseline weight at Week 26
(Mesure Description: To determine whether AZD5004 is superior to placebo on the proportion of participants with weight loss 5% or more from baseline)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Adults 18 years of age or more.

- BMI (a) 30 kg/m2 or more, or (b) 27 kg/m2 or more and have a current diagnosis of at least 1 of the following weight-related comorbidities (treated or untreated):
(i) Hypertension
(ii) Dyslipidemia or hyperlipidemia
(iii) CV disease
(iv) Obstructive sleep apnea

- 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 monogenic or syndromic obesity such as 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 type 2 diabetes mellitus.

- Clinically significant inflammatory bowel disease, gastroparesis, severe disease, or surgery affecting the upper GI tract.

- History of acute or chronic pancreatitis.

Related Information

• Primary Sponsor: Ageishi Yuji
• Secondary ID(s): NCT06579092