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
2 other identifiers
interventional
262
5 countries
41
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2024
Shorter than P25 for phase_2
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 11, 2024
CompletedFirst Posted
Study publicly available on registry
September 19, 2024
CompletedStudy Start
First participant enrolled
October 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 8, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 3, 2025
CompletedDecember 17, 2025
December 1, 2025
10 months
September 11, 2024
December 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (5)
Weight loss ≥ 5% from baseline to week 36
36 weeks
Weight loss ≥ 10% from baseline to week 36
36 weeks
Percent change in body weight from baseline to week 36
36 weeks
Absolute change in body weight (kg) from baseline to week 26 and week 36
week 26 and week 36
AZD6234 plasma concentrations
Week 43
Study Arms (4)
Arm 1
EXPERIMENTALDose 1
Arm 2
EXPERIMENTALDose 2
Arm 3
EXPERIMENTALDose 3
Arm 4
PLACEBO COMPARATORPlacebo - Dose matched with each Experimental arm
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (41)
Research Site
Mobile, Alabama, 36608, United States
Research Site
Phoenix, Arizona, 85044, United States
Research Site
Long Beach, California, 90815, United States
Research Site
Hialeah, Florida, 33012, United States
Research Site
Largo, Florida, 33777, United States
Research Site
Orlando, Florida, 32825, United States
Research Site
Tampa, Florida, 33606, United States
Research Site
Woodstock, Georgia, 30189, United States
Research Site
Indianapolis, Indiana, 46260, United States
Research Site
Lutherville-Timonium, Maryland, 21093, United States
Research Site
Gulfport, Mississippi, 39503, United States
Research Site
Ridgeland, Mississippi, 39157, United States
Research Site
Kansas City, Missouri, 64111, United States
Research Site
Omaha, Nebraska, 68134, United States
Research Site
Portsmouth, New Hampshire, 03801, United States
Research Site
Statesville, North Carolina, 28625, United States
Research Site
North Charleston, South Carolina, 29405, United States
Research Site
Knoxville, Tennessee, 37938, United States
Research Site
Austin, Texas, 78731, United States
Research Site
Dallas, Texas, 75230, United States
Research Site
Port Arthur, Texas, 77642, United States
Research Site
San Antonio, Texas, 78231, United States
Research Site
San Antonio, Texas, 78249, United States
Research Site
Heidelberg, 3081, Australia
Research Site
Maroochydore, 4556, Australia
Research Site
Maroubra, 2035, Australia
Research Site
Merewether, 2291, Australia
Research Site
Hamilton, Ontario, L8L 5G8, Canada
Research Site
Sarnia, Ontario, N7T 4X3, Canada
Research Site
Stouffville, Ontario, L4A1H2, Canada
Research Site
Toronto, Ontario, M3J 2C5, Canada
Research Site
Montreal, Quebec, H4N 2W2, Canada
Research Site
Sherbrooke, Quebec, J1L 0H8, Canada
Research Site
Chūōku, 103-0027, Japan
Research Site
Chūōku, 104-0031, Japan
Research Site
Shinjuku-ku, 160-0008, Japan
Research Site
Suita-shi, 565-0853, Japan
Research Site
Hull, HU3 2PA, United Kingdom
Research Site
Leicester, Le5 4PW, United Kingdom
Research Site
Penarth, CF64 2XX, United Kingdom
Research Site
Rotherham, S65 1DA, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2024
First Posted
September 19, 2024
Study Start
October 1, 2024
Primary Completion
August 8, 2025
Study Completion
December 3, 2025
Last Updated
December 17, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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.
- 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.
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.