Obesity or OverweightPhase 2APRICUSNCT06595238
A Study in Participants With Obesity or Overweight With at Least One Weight-related Comorbidity
A Phase 2 study testing AZD6234 in people with Obesity or Overweight, run by AstraZeneca at 41 sites in 5 countries.
Trial 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] ≥… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity or Overweight
- What is being tested?
- AZD6234
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 262 participants
- Where
- 41 sitesin 5 countries
- Study dates
- 1 Oct 2024to 3 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
41 sites in 5 countries.
41 sites in 5 countries
United States23 sites
Research Site
Austin, Texas, 78731
Research Site
Dallas, Texas, 75230
Research Site
Gulfport, Mississippi, 39503
Research Site
Hialeah, Florida, 33012
Research Site
Indianapolis, Indiana, 46260
Research Site
Kansas City, Missouri, 64111
Research Site
Knoxville, Tennessee, 37938
Research Site
Largo, Florida, 33777
Research Site
Long Beach, California, 90815
Research Site
Lutherville-Timonium, Maryland, 21093
Research Site
Mobile, Alabama, 36608
Research Site
North Charleston, South Carolina, 29405
Research Site
Omaha, Nebraska, 68134
Research Site
Orlando, Florida, 32825
Research Site
Phoenix, Arizona, 85044
Research Site
Port Arthur, Texas, 77642
Research Site
Portsmouth, New Hampshire, 03801
Research Site
Ridgeland, Mississippi, 39157
Research Site
San Antonio, Texas, 78231
Research Site
San Antonio, Texas, 78249
Research Site
Statesville, North Carolina, 28625
Research Site
Tampa, Florida, 33606
Research Site
Woodstock, Georgia, 30189
Canada6 sites
Research Site
Hamilton, Ontario, L8L 5G8
Research Site
Montreal, Quebec, H4N 2W2
Research Site
Sarnia, Ontario, N7T 4X3
Research Site
Sherbrooke, Quebec, J1L 0H8
Research Site
Stouffville, Ontario, L4A1H2
Research Site
Toronto, Ontario, M3J 0K2
Australia4 sites
Research Site
Heidelberg, 3081
Research Site
Maroochydore, 4556
Research Site
Maroubra, 2035
Research Site
Merewether, 2291
Japan4 sites
Research Site
Chūōku, 103-0027
Research Site
Chūōku, 104-0031
Research Site
Shinjuku-ku, 160-0008
Research Site
Suita-shi, 565-0853
United Kingdom4 sites
Research Site
Hull, HU3 2PA
Research Site
Leicester, Le5 4PW
Research Site
Penarth, CF64 2XX
Research Site
Rotherham, S65 1DA
About this study
Official 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
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
- Conditions
- Obesity or Overweight
- Being tested
- AZD6234, Placebo comparator
- Keywords
- Obesity, Overweight
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD6234Drug
IMP injected subcutaneously, once a week. Unit dose strength as per CSP
Placebo comparatorDrug
Placebo matching IMP dose injected subcutaneously, once a week.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Dose 1 Receives: Drug: AZD6234 |
| Arm 2 | Experimental | Dose 2 Receives: Drug: AZD6234 |
| Arm 3 | Experimental | Dose 3 Receives: Drug: AZD6234 |
| Arm 4 | Placebo comparator | Placebo - Dose matched with each Experimental arm Receives: Drug: Placebo comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in body weight from baseline to week 26
To determine whether AZD6234 is superior to placebo for weight loss
Measured: 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
Measured: 26 weeks
Secondary outcomes (5)
Weight loss ≥ 5% from baseline to week 36
To determine whether AZD6234 is superior to placebo in participants with weight loss ≥ 5% from baseline
Measured: 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
Measured: 36 weeks
Percent change in body weight from baseline to week 36
To determine whether AZD6234 is superior to placebo for weight loss
Measured: 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
Measured: week 26 and week 36
AZD6234 plasma concentrations
To characterise the PK of AZD6234
Measured: Week 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2024
- Primary completion3 Dec 2025
- Study completion3 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity or OverweightStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06595238
- Sponsor's protocol ID
- D8750C00004
- Other IDs
- 2024-514000-13-00
- Acronym
- APRICUS
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2024
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06595238
- Acronym / sponsor ID
- APRICUS / D8750C00004
- Conditions
- Obesity or Overweight
- Keywords
- Obesity, Overweight
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 3 Dec 2025 (actual)
- Study completion
- 3 Dec 2025 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: AZD6234Dose 1 |
| Arm 2 | Experimental | Drug: AZD6234Dose 2 |
| Arm 3 | Experimental | Drug: AZD6234Dose 3 |
| Arm 4 | Placebo comparator | Drug: Placebo comparatorPlacebo - Dose matched with each Experimental arm |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD6234IMP injected subcutaneously, once a week. Unit dose strength as per CSP | Drug | Arm 1, Arm 2, Arm 3 |
| Placebo comparatorPlacebo matching IMP dose injected subcutaneously, once a week. | Drug | Arm 4 |
Primary outcome
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
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
5 secondary outcomes
Weight loss ≥ 5% from baseline to week 36
Time frame: 36 weeks
Weight loss ≥ 10% from baseline to week 36
Time frame: 36 weeks
Percent change in body weight from baseline to week 36
Time frame: 36 weeks
Absolute change in body weight (kg) from baseline to week 26 and week 36
Time frame: week 26 and week 36
AZD6234 plasma concentrations
Time frame: Week 43
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: 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.
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RecruitingPhase 1
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
41 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AZD6234 in people with Obesity or Overweight, run by AstraZeneca at 41 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States, Canada, Australia, Japan, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in body weight from baseline to week 26 (time frame: 26 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.