AZD5004 for Obesity

(VISTA Trial)

Recruiting in Palo Alto (17 mi)

+65 other locations

Overseen by Prof Melanie Davies, MBChB MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: AstraZeneca

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

A Phase IIb, global, randomized, parallel-group, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of AZD5004 compared with placebo, given once daily as an oral tablet(s) for 36 weeks, in male and female participants at least 18 years of age who are living with obesity (body mass index \[BMI\] ≥ 30 kg/m2), or overweight (BMI ≥ 27 kg/m2) who have at least 1 weight-related comorbidity

Research Team

Prof Melanie Davies, MBChB MD

Principal Investigator

Diabetes Research Centre Leicester Diabetes Centre - Bloom University of Leicester

Eligibility Criteria

This trial is for adults at least 18 years old who are living with obesity (BMI ≥ 30 kg/m2) or overweight (BMI ≥ 27 kg/m2) with at least one weight-related health issue. Specific eligibility details were not provided, so interested individuals should inquire about additional inclusion and exclusion criteria.

Inclusion Criteria

I am at least 18 years old.

I can sign and understand the consent form.

I am using effective birth control that is not the pill during the study.

Exclusion Criteria

Hemoglobin A1c (HbA1c) ≥ 6.5% (48 mmol/mol) at Screening

I have taken diabetes medication in the last 3 months.

Cardiac arrhythmia or electrocardiogram (ECG) morphology abnormalities, as considered by the investigator, that may interfere with interpretation of QT interval corrected for heart rate (QTc) interval changes, including ST wave morphology

Treatment Details

Interventions

• AZD5004 (Other)

Trial Overview The study is testing the effects of a new drug called AZD5004 compared to a placebo. Participants will take an oral tablet once daily for 36 weeks in this double-blind study, meaning neither they nor the researchers know who gets the real drug or placebo.

Participant Groups

Group I: Arm 5 Experimental Treatment 2 Interventions

00mg dose or placebo

Group II: Arm 4 Experimental Treatment 2 Interventions

00mg dose or placebo

Group III: Arm 3 Experimental Treatment 2 Interventions

00mg dose or placebo

Group IV: Arm 2 Experimental Treatment 2 Interventions

00mg dose or placebo

Group V: Arm 1 Experimental Treatment 2 Interventions

00mg dose or placebo

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology