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Completed

NCT Number: NCT06595238

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

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

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Key information

Conditions

Obesity or Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Heidelberg, Australia

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD6234

Drug

IMP injected subcutaneously, once a week. Unit dose strength as per CSP

placebo comparator

Drug

Placebo matching IMP dose injected subcutaneously, once a week.

Primary outcomes

  1. Percent change in body weight from baseline to week 26

    Time frame: 26 weeks

    To determine whether AZD6234 is superior to placebo for weight loss

  2. Weight loss ≥ 5% from baseline weight to week 26

    Time frame: 26 weeks

    To determine whether AZD6234 is superior to placebo in participants with weight loss ≥ 5% from baseline

Secondary outcomes

  1. Weight loss ≥ 5% from baseline to week 36

    Time frame: 36 weeks

    To determine whether AZD6234 is superior to placebo in participants with weight loss ≥ 5% from baseline

  2. Weight loss ≥ 10% from baseline to week 36

    Time frame: 36 weeks

    To determine whether AZD6234 is superior to placebo in participants with weight loss ≥ 10% from baseline

  3. Percent change in body weight from baseline to week 36

    Time frame: 36 weeks

    To determine whether AZD6234 is superior to placebo for weight loss

  4. Absolute change in body weight (kg) from baseline to week 26 and week 36

    Time frame: week 26 and week 36

    To determine whether AZD6234 is superior to placebo for absolute weight loss

  5. AZD6234 plasma concentrations

    Time frame: Week 43

    To characterise the PK of AZD6234

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Phase IIb Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of AZD6234 in Participants Living With Obesity or Overweight With Comorbidity

Acronym: APRICUS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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