臨床研究等提出・公開システム

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 (VISTA)

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

Ageishi Yuji

Astrazeneka K.K

3-1, Ofuka-cho, Kita-ku, Osaka-shi

RD-clinical-information-Japan@astrazeneca.com

Ageishi Yuji

Astrazeneka K.K

3-1, Ofuka-cho, Kita-ku, Osaka-shi

+81-6-4802-3533

RD-clinical-information-Japan@astrazeneca.com

Complete

Nov. 12, 2024

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

- 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).

- 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.

Both

Obesity

Drug: AZD5004
Drug: Placebo

- 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)

+81-6-6395-9000

Sept. 20, 2024

Yes

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

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