ObesityPhase 3SELENE-AsiaNCT07922330
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
A Phase 3 study testing AZD6234 in people with Obesity and Overweight, run by AstraZeneca at 34 sites in 2 countries.
Trial summary
This study will evaluate the efficacy and safety of AZD6234 compared with placebo in adults who are overweight or obese, with or without type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Overweight, Type 2 Diabetes Mellitus
- What is being tested?
- AZD6234
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 330 participants
- Where
- 34 sitesin 2 countries
- Study dates
- 4 Jan 2027to 15 Sep 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older at the time of signing informed consent.
- Body mass index:
- at least 28 kg/m²; or
- at least 24 kg/m² and less than 28 kg/m² with at least one protocol-defined weight-related comorbidity, including type 2 diabetes mellitus, hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, heart failure, chronic kidney disease, metabolic dysfunction-associated steatotic liver disease, knee osteoarthritis, or stress urinary incontinence.
- Stable body weight (≤ 5% body weight change) for at least 3 months prior to Randomisation.
- Participants with type 2 diabetes mellitus must:
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- have been diagnosed at least 6 months before informed consent;
- have HbA1c between 6.0% and 10.0% at Screening; and
- be managed with diet and exercise alone or with a stable dose of 1 to 3 oral glucose-lowering medications for at least 3 months before Screening.
- At least one previous self-reported unsuccessful attempt to lose body weight.
- Participants of childbearing potential must comply with protocol-defined highly effective contraception requirements and have negative pregnancy tests at Screening and Randomisation.
- Able to provide signed informed consent.
Who cannot join
- Obesity primarily caused by another endocrine disorder.
- Severe heart failure, defined as New York Heart Association Class IV, or hospitalisation for heart failure within 3 months before Screening.
- Type 1 diabetes mellitus or ketoacidosis or hyperosmolar coma/state within 3 months before Screening.
- Clinically significant gastric-emptying abnormality requiring treatment.
- Significant inflammatory bowel disease or another severe disease or prior surgery affecting the upper gastrointestinal tract.
- Cardiovascular event, percutaneous coronary intervention, or coronary artery bypass graft within 3 months before Screening.
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- Previous or planned surgical treatment for obesity.
- Uncontrolled hypothyroidism or hyperthyroidism.
- Significant hepatobiliary disease, including protocol-defined elevations in alanine aminotransferase, aspartate aminotransferase, or total bilirubin.
- Neoplastic disease within 5 years before Screening, except as otherwise permitted by the protocol.
- Clinically important disease or disorder that may place the participant at risk or interfere with study participation.
- Known or suspected drug abuse or alcohol abuse.
- Planned elective surgery requiring discontinuation of study intervention for more than 6 weeks.
- Weight-management treatment within 3 months before Randomisation.
- Treatment with a glucagon-like peptide-1 receptor agonist or another glucagon-like peptide-1-containing medication within 3 months before Randomisation.
- Treatment with a marketed or investigational amylin-based compound within 3 months before Randomisation.
- Use of insulin therapy for type 2 diabetes mellitus.
- Long-term systemic glucocorticoid treatment lasting more than 14 days or use of central nervous system stimulants.
- Concomitant medication that may increase risk, affect study results, or interfere with study participation.
- Unstable major depressive disorder or Patient Health Questionnaire-9 score of 15 or higher.
- History of psychosis or active symptomatic bipolar disorder.
- Active suicidal ideation corresponding to Category 4 or 5 on the Columbia-Suicide Severity Rating Scale, or history of a suicide attempt.
- Participation in another clinical study within 30 days before Screening.
- Known hypersensitivity to AZD6234.
- Involvement in the planning and/or conduct of the study.
- Unlikely or unable to comply with study procedures, restrictions, or requirements.
- Previous randomisation in the present study.
- Currently pregnant or breastfeeding.
- Any other condition that, in the Investigator's judgement, makes participation inappropriate.
Trial locations and contacts
34 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
34 sites in 2 countries
China28 sites
Research Site
Beijing, 100029
Research Site
Bozhou, 236000
Research Site
Cangzhou, 061002
Research Site
Changzhou, 213004
Research Site
Chongqing, 402260
Research Site
Daqing, 163316
Research Site
Ganzhou, 341099
Research Site
Guangzhou, 510150
Research Site
Guangzhou, 510800
Research Site
Jiaxing, 314001
Research Site
Jinan, 250013
Research Site
Jinan, 250031
Research Site
Liuzhou, 545005
Research Site
Luoyang, 471003
Research Site
Luzhou, 646000
Research Site
Sanya, 572000
Research Site
Shanghai, 200031
Research Site
Shanghai, 201700
Research Site
Shanghai, 310000
Research Site
Shenyang, 110016
Research Site
Shenyang, 110023
Research Site
Shiyan, 442099
Research Site
Suzhou, 215004
Research Site
Wuhan, 430060
Research Site
Xi'an, 710068
Research Site
Xuancheng, 242000
Research Site
Yuncheng, 044099
Research Site
Zhengzhou, 450007
India6 sites
Research Site
Ansārinagar, 110 029
Research Site
Calicut, 673008
Research Site
Kolkata, 700014
Research Site
Ludhiana, 141001
Research Site
Meerut, 250005
Research Site
Surat, 395002
About this study
Official title: A Phase III, Randomised, Double-Blind, Placebo-Controlled, Multicentre Trial to Evaluate the Efficacy and Safety of AZD6234 in Participants With Obesity or Overweight With at Least One Weight Related Comorbidity With or Without Type 2 Diabetes Mellitus (SELENE-Asia)
This study will evaluate the efficacy and safety of AZD6234 compared with placebo in adults who are overweight or obese, with or without type 2 diabetes mellitus.
- Conditions
- Obesity, Overweight, Type 2 Diabetes Mellitus
- Being tested
- AZD6234, Placebo
- Keywords
- Obesity, Overweight
- Medical subject headings
- Obesity, Overweight, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD6234Drug
administered once weekly.
PlaceboDrug
Matching placebo administered once weekly.
| Study group | Role | What they receive |
|---|---|---|
| AZD6234 Higher Target-Dose | Experimental | Participants will receive AZD6234 with dose titration to the higher target dose, followed by a safety follow-up period. Receives: Drug: AZD6234 |
| AZD6234 Lower Target-Dose | Experimental | Participants will receive AZD6234 with dose titration to the lower target dose, followed by a safety follow-up period. Receives: Drug: AZD6234 |
| Placebo | Placebo comparator | Participants will receive matching placebo with dose titration according to the protocol, followed by a safety follow-up period. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in body weight from baseline at Week 64
To evaluate the effect of AZD6234 as compared to placebo in percent body weight change from baseline of treatment.
Measured: up to 64 weeks
Number of participants achieving at Least a 5% Reduction in Body Weight From Baseline at Week 64
To evaluate the effect of AZD6234 as compared to placebo in body weight loss of at least 5% from baseline of treatment.
Measured: up to 64 weeks
Secondary outcomes (6)
Number of participants achieving at Least a 10% Reduction in Body Weight From Baseline at Week 64
To evaluate the effect of AZD6234 as compared to placebo in body weight loss of at least 10% from baseline of treatment.
Measured: up to 64 weeks
Change in waist circumference from baseline
To evaluate the effect of AZD6234 as compared to placebo in waist circumference change from baseline of treatment.
Measured: up to 64 weeks
Absolute change in weight from baseline
To evaluate the effect of AZD6234 as compared to placebo on absolute change in weight from baseline of treatment.
Measured: up to 64 weeks
Percent change in triglycerides from baseline
To evaluate the effect of AZD6234 as compared to placebo on triglycerides percent change from baseline of treatment.
Measured: up to 64 weeks
Change in systolic BP from baseline
To evaluate the effect of AZD6234 as compared to placebo on systolic BP change from baseline of treatment.
Measured: up to 64 weeks
Number of Participants With Adverse Events
Number of participants with prespecified adverse event categories.
Measured: From first administration through Week 64 and the 4-week safety follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start4 Jan 2027 (estimated)
- Primary completion15 Sep 2028 (estimated)
- Study completion15 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07922330
- Sponsor's protocol ID
- D8750C00019
- Acronym
- SELENE-Asia
- Status last verified
- Nov 2026
- First submitted
- 13 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- 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 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomised, Double-Blind, Placebo-Controlled, Multicentre Trial to Evaluate the Efficacy and Safety of AZD6234 in Participants With Obesity or Overweight With at Least One Weight Related Comorbidity With or Without Type 2 Diabetes Mellitus (SELENE-Asia)
- ClinicalTrials.gov ID
- NCT07922330
- Acronym / sponsor ID
- SELENE-Asia / D8750C00019
- Conditions
- Obesity, Overweight, Type 2 Diabetes Mellitus
- Keywords
- Obesity, Overweight
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 4 Jan 2027 (estimated)
- Primary completion
- 15 Sep 2028 (estimated)
- Study completion
- 15 Sep 2028 (estimated)
- First posted
- 6 Nov 2026 (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.
This study will evaluate the efficacy and safety of AZD6234 compared with placebo in adults who are overweight or obese, with or without type 2 diabetes mellitus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AZD6234 Higher Target-Dose | Experimental | Drug: AZD6234Participants will receive AZD6234 with dose titration to the higher target dose, followed by a safety follow-up period. |
| AZD6234 Lower Target-Dose | Experimental | Drug: AZD6234Participants will receive AZD6234 with dose titration to the lower target dose, followed by a safety follow-up period. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive matching placebo with dose titration according to the protocol, followed by a safety follow-up period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Aged 18 years or older at the time of signing informed consent.
- Body mass index:
- at least 28 kg/m²; or
- at least 24 kg/m² and less than 28 kg/m² with at least one protocol-defined weight-related comorbidity, including type 2 diabetes mellitus, hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, heart failure, chronic kidney disease, metabolic dysfunction-associated steatotic liver disease, knee osteoarthritis, or stress urinary incontinence.
- Stable body weight (≤ 5% body weight change) for at least 3 months prior to Randomisation.
Key exclusion criteria (29 listed)
- Obesity primarily caused by another endocrine disorder.
- Severe heart failure, defined as New York Heart Association Class IV, or hospitalisation for heart failure within 3 months before Screening.
- Type 1 diabetes mellitus or ketoacidosis or hyperosmolar coma/state within 3 months before Screening.
- Clinically significant gastric-emptying abnormality requiring treatment.
- Significant inflammatory bowel disease or another severe disease or prior surgery affecting the upper gastrointestinal tract.
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 |
|---|---|---|
| AZD6234administered once weekly. | Drug | AZD6234 Higher Target-Dose, AZD6234 Lower Target-Dose |
| PlaceboMatching placebo administered once weekly. | Drug | Placebo |
Primary outcome
Percent change in body weight from baseline at Week 64
Time frame: up to 64 weeks
To evaluate the effect of AZD6234 as compared to placebo in percent body weight change from baseline of treatment.
Number of participants achieving at Least a 5% Reduction in Body Weight From Baseline at Week 64
Time frame: up to 64 weeks
To evaluate the effect of AZD6234 as compared to placebo in body weight loss of at least 5% from baseline of treatment.
6 secondary outcomes
Number of participants achieving at Least a 10% Reduction in Body Weight From Baseline at Week 64
Time frame: up to 64 weeks
Change in waist circumference from baseline
Time frame: up to 64 weeks
Absolute change in weight from baseline
Time frame: up to 64 weeks
Percent change in triglycerides from baseline
Time frame: up to 64 weeks
Change in systolic BP from baseline
Time frame: up to 64 weeks
Number of Participants With Adverse Events
Time frame: From first administration through Week 64 and the 4-week safety follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 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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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.
AstraZeneca Clinical Study Information Center contact
34 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AZD6234 in people with Obesity and Overweight, run by AstraZeneca at 34 sites in 2 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 12 inclusion and 29 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: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in China, India. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in body weight from baseline at Week 64 (time frame: up to 64 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 6 Nov 2026.