ClinicalTrials.gg
Not yet recruitingNCT07922330SELENE-AsiaUpdated Nov 6, 2026

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 interventional study of AZD6234 and Placebo in Obesity, Overweight and Type 2 Diabetes Mellitus, sponsored by AstraZeneca. Not yet recruiting at 34 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment

Updated Nov 6, 2026Newly registeredGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
330
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Obesity
  • Overweight
  • Type 2 Diabetes Mellitus

Keywords

  • Obesity
  • Overweight
03

In context

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's planned enrollment of 330 is above the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,499 studies on the registry; 270 are open to participants now.

Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Aged 18 years or older at the time of signing .
  • :
  • 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:
  • have been diagnosed at least 6 months before informed consent;
  • have 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 must comply with protocol-defined highly effective requirements and have negative pregnancy tests at Screening and Randomisation.
  • Able to provide signed informed consent.

Exclusion criteria

Exclusion Criteria:

  • Obesity primarily caused by another endocrine disorder.
  • Severe heart failure, defined as 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.
  • 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.
  • Previous or planned surgical treatment for obesity.
  • Uncontrolled hypothyroidism or hyperthyroidism.
  • Significant hepatobiliary disease, including protocol-defined elevations in , aspartate aminotransferase, or total .
  • 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 amylin-based compound within 3 months before Randomisation.
  • Use of insulin therapy for type 2 diabetes mellitus.
  • Long-term systemic 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 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.
Terms in these criteria, in plain language(12)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
330 participants (estimated)

Study arms

  • Experimental
    AZD6234 Higher Target-Dose

    Participants will receive AZD6234 with dose titration to the higher target dose, followed by a safety follow-up period.

    Drug: AZD6234

  • Experimental
    AZD6234 Lower Target-Dose

    Participants will receive AZD6234 with dose titration to the lower target dose, followed by a safety follow-up period.

    Drug: AZD6234

  • Placebo comparator
    Placebo

    Participants will receive matching placebo with dose titration according to the protocol, followed by a safety follow-up period.

    Drug: Placebo

Interventions

  • administered once weekly.

  • DrugPlacebo

    Matching placebo administered once weekly.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: up to 64 weeks

  2. 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.

    Time frame: up to 64 weeks

Secondary outcomes

  1. 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.

    Time frame: up to 64 weeks

  2. Change in waist circumference from baseline

    To evaluate the effect of AZD6234 as compared to placebo in waist circumference change from baseline of treatment.

    Time frame: up to 64 weeks

  3. 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.

    Time frame: up to 64 weeks

  4. Percent change in triglycerides from baseline

    To evaluate the effect of AZD6234 as compared to placebo on triglycerides percent change from baseline of treatment.

    Time frame: up to 64 weeks

  5. Change in systolic BP from baseline

    To evaluate the effect of AZD6234 as compared to placebo on systolic BP change from baseline of treatment.

    Time frame: up to 64 weeks

  6. Number of Participants With Adverse Events

    Number of participants with prespecified adverse event categories.

    Time frame: From first administration through Week 64 and the 4-week safety follow-up

07

Study locations

34 sites
  • Research Site
    Beijing, 100029, China
  • Research Site
    Bozhou, 236000, China
  • Research Site
    Cangzhou, 061002, China
  • Research Site
    Changzhou, 213004, China
  • Research Site
    Chongqing, 402260, China
  • Research Site
    Daqing, 163316, China
  • Research Site
    Ganzhou, 341099, China
  • Research Site
    Guangzhou, 510150, China
  • Research Site
    Guangzhou, 510800, China
  • Research Site
    Jiaxing, 314001, China
  • Research Site
    Jinan, 250013, China
  • Research Site
    Jinan, 250031, China
  • Research Site
    Liuzhou, 545005, China
  • Research Site
    Luoyang, 471003, China
  • Research Site
    Luzhou, 646000, China
  • Research Site
    Sanya, 572000, China
  • Research Site
    Shanghai, 200031, China
  • Research Site
    Shanghai, 201700, China
  • Research Site
    Shanghai, 310000, China
  • Research Site
    Shenyang, 110016, China
  • Research Site
    Shenyang, 110023, China
  • Research Site
    Shiyan, 442099, China
  • Research Site
    Suzhou, 215004, China
  • Research Site
    Wuhan, 430060, China
  • Research Site
    Xi'an, 710068, China
  • Research Site
    Xuancheng, 242000, China
  • Research Site
    Yuncheng, 044099, China
  • Research Site
    Zhengzhou, 450007, China
  • Research Site
    Ansārinagar, 110 029, India
  • Research Site
    Calicut, 673008, India
  • Research Site
    Kolkata, 700014, India
  • Research Site
    Ludhiana, 141001, India
  • Research Site
    Meerut, 250005, India
  • Research Site
    Surat, 395002, India
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, Statistical analysis plan

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.

Data sharing details ↗ · vivli.org

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jan 2027; primary completion for Sep 2028, 20 months later.

Of 198 industry-sponsored phase 3 interventional studies under Obesity, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 27. This study's planned 20 months is close to that.

Counting every sponsor, half of 261 studies reached it within 24 months; a quarter within 18 and three quarters within 34.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 13, 2026
First posted
Nov 6, 2026
StartEst.
Jan 4, 2027
Primary completionEst.
Sep 15, 2028
CompletionEst.
Sep 15, 2028
Last update
Nov 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 6, 2026
Show all 1 update
  1. Nov 6, 2026
    First appeared on the registry

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
NCT07922330
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Nov 6, 2026
Start date
Jan 4, 2027 (estimated)
Primary completion
Sep 15, 2028 (estimated)
Completion
Sep 15, 2028 (estimated)
Last update
Nov 6, 2026

Study contacts

AstraZeneca Clinical Study Information Center
Contact
information.center@astrazeneca.com
1-877-240-9479

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: AZD6234

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