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CompletedNCT06595238APRICUSUpdated Oct 2, 2026

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

A Phase 2 interventional study of AZD6234 and Placebo comparator in Obesity or Overweight, sponsored by AstraZeneca. Completed at 41 sites in 5 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-02.

Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
262
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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

Read the 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

02

Conditions studied

  • Obesity or Overweight

Keywords

  • Obesity
  • Overweight
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 262 is above the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
262 participants (actual)

Study arms

  • Experimental
    Arm 1

    Dose 1

    Drug: AZD6234

  • Experimental
    Arm 2

    Dose 2

    Drug: AZD6234

  • Experimental
    Arm 3

    Dose 3

    Drug: AZD6234

  • Placebo comparator
    Arm 4

    Placebo - Dose matched with each Experimental arm

    Drug: Placebo comparator

Interventions

  • DrugAZD6234

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

  • DrugPlacebo comparator

    Placebo matching IMP dose injected subcutaneously, once a week.

06

What researchers measure

Primary outcomes

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

    To determine whether AZD6234 is superior to placebo for weight loss

    Time frame: 26 weeks

  2. 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

    Time frame: 26 weeks

Secondary outcomes

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

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

    Time frame: 36 weeks

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

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

    Time frame: 36 weeks

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

    To determine whether AZD6234 is superior to placebo for weight loss

    Time frame: 36 weeks

  4. 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

    Time frame: week 26 and week 36

  5. AZD6234 plasma concentrations

    To characterise the PK of AZD6234

    Time frame: Week 43

07

Study locations

41 sites
  • 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 0K2, 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
08

References and documents

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Sap

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date and registry dates
1 update, last Oct 2, 2026
Show all 1 update
  1. Oct 2, 2026
    Minor edits only
    + 2 other changes: verification date and registry dates

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06595238
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Sep 19, 2024
Start date
Oct 1, 2024
Primary completion
Dec 3, 2025
Completion
Dec 3, 2025
Last update
Oct 2, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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