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

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

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

Study Overview

• Status: Completed
• Conditions: Obesity or Overweight
• Intervention / Treatment: Drug: AZD6234; Drug: Placebo comparator

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 262
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Heidelberg, Australia, 3081
    • Research Site
  • Maroochydore, Australia, 4556
    • Research Site
  • Maroubra, Australia, 2035
    • Research Site
  • Merewether, Australia, 2291
    • Research Site
• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8L 5G8
      • Research Site
    • Sarnia, Ontario, Canada, N7T 4X3
      • Research Site
    • Stouffville, Ontario, Canada, L4A1H2
      • Research Site
    • Toronto, Ontario, Canada, M3J 2C5
      • Research Site
  • Quebec
    • Montreal, Quebec, Canada, H4N 2W2
      • Research Site
    • Sherbrooke, Quebec, Canada, J1L 0H8
      • Research Site
• Japan
  • Chūōku, Japan, 103-0027
    • Research Site
  • Chūōku, Japan, 104-0031
    • Research Site
  • Shinjuku-ku, Japan, 160-0008
    • Research Site
  • Suita-shi, Japan, 565-0853
    • Research Site
• United Kingdom
  • Hull, United Kingdom, HU3 2PA
    • Research Site
  • Leicester, United Kingdom, Le5 4PW
    • Research Site
  • Penarth, United Kingdom, CF64 2XX
    • Research Site
  • Rotherham, United Kingdom, S65 1DA
    • Research Site
• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • Research Site
  • Arizona
    • Phoenix, Arizona, United States, 85044
      • Research Site
  • California
    • Long Beach, California, United States, 90815
      • Research Site
  • Florida
    • Hialeah, Florida, United States, 33012
      • Research Site
    • Largo, Florida, United States, 33777
      • Research Site
    • Orlando, Florida, United States, 32825
      • Research Site
    • Tampa, Florida, United States, 33606
      • Research Site
  • Georgia
    • Woodstock, Georgia, United States, 30189
      • Research Site
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Research Site
  • Maryland
    • Lutherville-Timonium, Maryland, United States, 21093
      • Research Site
  • Mississippi
    • Gulfport, Mississippi, United States, 39503
      • Research Site
    • Ridgeland, Mississippi, United States, 39157
      • Research Site
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Research Site
  • Nebraska
    • Omaha, Nebraska, United States, 68134
      • Research Site
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
      • Research Site
  • North Carolina
    • Statesville, North Carolina, United States, 28625
      • Research Site
  • South Carolina
    • North Charleston, South Carolina, United States, 29405
      • Research Site
  • Tennessee
    • Knoxville, Tennessee, United States, 37938
      • Research Site
  • Texas
    • Austin, Texas, United States, 78731
      • Research Site
    • Dallas, Texas, United States, 75230
      • Research Site
    • Port Arthur, Texas, United States, 77642
      • Research Site
    • San Antonio, Texas, United States, 78249
      • Research Site
    • San Antonio, Texas, United States, 78231
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; Dose 1	Drug: AZD6234; IMP injected subcutaneously, once a week. Unit dose strength as per CSP
Experimental: Arm 2; Dose 2	Drug: AZD6234; IMP injected subcutaneously, once a week. Unit dose strength as per CSP
Experimental: Arm 3; Dose 3	Drug: AZD6234; IMP injected subcutaneously, once a week. Unit dose strength as per CSP
Placebo Comparator: Arm 4; Placebo - Dose matched with each Experimental arm	Drug: Placebo comparator; Placebo matching IMP dose injected subcutaneously, once a week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent change in body weight from baseline to week 26	To determine whether AZD6234 is superior to placebo for weight loss	26 weeks
Weight loss ≥ 5% from baseline weight to week 26	To determine whether AZD6234 is superior to placebo in participants with weight loss ≥ 5% from baseline	26 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight loss ≥ 5% from baseline to week 36	To determine whether AZD6234 is superior to placebo in participants with weight loss ≥ 5% from baseline	36 weeks
Weight loss ≥ 10% from baseline to week 36	To determine whether AZD6234 is superior to placebo in participants with weight loss ≥ 10% from baseline	36 weeks
Percent change in body weight from baseline to week 36	To determine whether AZD6234 is superior to placebo for weight loss	36 weeks
Absolute change in body weight (kg) from baseline to week 26 and week 36	To determine whether AZD6234 is superior to placebo for absolute weight loss	week 26 and week 36
AZD6234 plasma concentrations	To characterise the PK of AZD6234	Week 43

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Actual): August 8, 2025
• Study Completion (Actual): December 3, 2025

Study Registration Dates

• First Submitted: September 11, 2024
• First Submitted That Met QC Criteria: September 11, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Obesity; Overweight
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: D8750C00004; 2024-514000-13-00 (Registry Identifier: EU CT number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No