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

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

330

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

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)

January 4, 2027

Primary Completion (Estimated)

September 15, 2028

Study Completion (Estimated)

September 15, 2028

Study Registration Dates

First Submitted

October 13, 2026

First Submitted That Met QC Criteria

November 2, 2026

First Posted (Actual)

November 6, 2026

Study Record Updates

Last Update Posted (Actual)

November 6, 2026

Last Update Submitted That Met QC Criteria

November 2, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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