A Study in Participants With Obesity or Overweight With at Least One Weight-related Comorbidity (APRICUS)

AstraZeneca

Status and phase: Active, not recruiting; Phase 2

Conditions: Obesity or Overweight

Treatments: Drug: Placebo comparator; Drug: AZD6234

Study type: Interventional

Funder types: Industry

Identifiers

NCT06595238

D8750C00004

2024-514000-13-00 (Registry Identifier)

Details and patient eligibility

About

A Phase IIb Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of AZD6234 compared with placebo, given once a week as subcutaneous injection for 36 weeks, in male and female participants of at least 18 years of age who are living with obesity (body mass index [BMI] ≥ 30 kg/m2), or overweight (BMI ≥ 27 kg/m2) and at least one weight-related comorbidity

Full description

The study will comprise of:

A screening period of maximum 28 days

A treatment period of 36 weeks

A follow up period after last dose of study drug

This study will consist of 4 cohorts. Approximately 231 eligible participants will be randomized to AZD6234 or placebo

Enrollment: 262 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults ≥ 18 years of age
• BMI of (a) ≥ 30 kg/m2, or (b) ≥ 27kg/m2 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)

Exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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262 participants in 4 patient groups, including a placebo group

Arm 1

Experimental group

Description:

Dose 1

Treatment:

Drug: AZD6234

Arm 2

Experimental group

Description:

Dose 2

Treatment:

Drug: AZD6234

Arm 3

Experimental group

Description:

Dose 3

Treatment:

Drug: AZD6234

Arm 4

Placebo Comparator group

Description:

Placebo - Dose matched with each Experimental arm

Treatment:

Drug: Placebo comparator