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 (SELENE-Asia)

November 2, 2026 updated by: AstraZeneca

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
330

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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:
  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

administered once weekly.
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

administered once weekly.
Placebo Comparator: Placebo

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

Matching placebo administered once weekly.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
up to 64 weeks
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.
up to 64 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of participants achieving at Least a 10% 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 10% from baseline of treatment.
up to 64 weeks
Change in waist circumference from baseline
Time Frame: up to 64 weeks

To evaluate the effect of AZD6234 as compared to placebo in waist circumference change from baseline of treatment.
up to 64 weeks
Absolute change in weight from baseline
Time Frame: up to 64 weeks

To evaluate the effect of AZD6234 as compared to placebo on absolute change in weight from baseline of treatment.
up to 64 weeks
Percent change in triglycerides from baseline
Time Frame: up to 64 weeks

To evaluate the effect of AZD6234 as compared to placebo on triglycerides percent change from baseline of treatment.
up to 64 weeks
Change in systolic BP from baseline
Time Frame: up to 64 weeks

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

Number of participants with prespecified adverse event categories.
From first administration through Week 64 and the 4-week safety follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 4, 2027

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 15, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 15, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 13, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D8750C00019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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