Effects of AZD5004 in Adults Who Are Living With Obesity or Overweight With at Least 1 Weight-related Comorbidity (VISTA)

AstraZeneca

Status and phase: Not yet enrolling; Phase 2

Conditions: Obesity or Overweight

Treatments: Drug: Placebo; Drug: AZD5004

Study type: Interventional

Funder types: Industry

Identifiers

NCT06553599

D7260C00001

Details and patient eligibility

About

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

Full description

This is a Phase IIb, global, randomized, parallel-group, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of 5 doses of AZD5004 compared with placebo, given once daily as an oral tablet or tablets for a duration of 36 weeks, in adults aged 18 years and above, who are living with obesity (BMI ≥ 30 kg/m2), or overweight (BMI ≥ 27 kg/m2) and have at least 1 weight-related comorbidity (Hypertension, Dyslipidemia or hyperlipidemia, CV disease and/or Obstructive sleep apnea). Approximately 285 participants will be randomized in the study. The dual primary endpoints are percent change in body weight from baseline at 26 weeks and the proportion of participants with weight loss ≥ 5% of baseline weight at 26 weeks.

Enrollment: 285 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Be at least 18 years old at the time of signing the informed consent.

• At Screening, have a BMI: (a) ≥ 30 kg/m2, or (b) ≥ 27 kg/m2 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)

• Capable of giving signed informed consent

• Female(s) of childbearing potential (FOCBP):

  • Must use adequate contraception from enrollment, through the study, after the last dose of IMP.
  • Oral contraceptives are not permitted.

• Female(s) not of childbearing potential

• Male participants:

  • Condom use is required for the duration of the trial after the last dose of IMP
  • Additional contraception must be used for the sexual partners of male trial participants throughout the clinical trial following the last dose of IMP

Exclusion 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 T2DM
• Hemoglobin A1c (HbA1c) ≥ 6.5% (48 mmol/mol) at Screening
• Treatment with diabetes medication in past 3 months prior to Screening
• 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
• Clinically significant inflammatory bowel disease, gastroparesis, severe disease, or surgery affecting the upper GI tract
• History of psychosis or bipolar disorder

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

285 participants in 5 patient groups

Arm 2

Experimental group

Description:

00mg dose or placebo

Treatment:

Drug: Placebo

Drug: AZD5004

Arm 3

Experimental group

Description:

00mg dose or placebo

Treatment:

Drug: Placebo

Drug: AZD5004

Arm 4

Experimental group

Description:

00mg dose or placebo

Treatment:

Drug: Placebo

Drug: AZD5004

Arm 5

Experimental group

Description:

00mg dose or placebo

Treatment:

Drug: Placebo

Drug: AZD5004

Arm 1

Experimental group

Description:

00mg dose or placebo

Treatment:

Drug: Placebo

Drug: AZD5004