A Study to Evaluate Effect of AZD6234 as an Adjunct to Incretin-based Therapies in Adult Participants With Obesity or Overweight With Weight-related Comorbidity With or Without Type 2 Diabetes Mellitus (SELENE 3)

August 17, 2026 updated by: AstraZeneca

A Phase III Randomised, Double-Blind, Placebo-Controlled Multicentre Trial to Evaluate the Efficacy and Safety of AZD6234 as an Adjunct to Incretin-based Therapies in Participants With Obesity or Overweight With at Least One Weight-Related Comorbidity With or Without Type 2 Diabetes Mellitus (SELENE 3)

The study will evaluate how well AZD6234 works and how safe it is in adults with excess weight or obesity. Efficacy of AZD6234 will be compared to placebo in percent body weight change from baseline at 68 weeks of treatment.

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.

Detailed Description

This is a Phase III, global, randomised, parallel-group, double-blind, multicentre study to assess the efficacy and safety of AZD6234 as an adjunct to incretin-based therapies, compared with placebo in adults with obesity or overweight with at least one weight-related comorbidity and with or without Type 2 Diabetes Mellitus (T2DM). Eligible participants will be randomised to either receive AZD6234 or matching placebo respectively. Study treatment (AZD6234 or placebo) will be added on to the participant's stable dose of background incretin-based therapies.

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.
500

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

  • Argentina
      • CABA, Argentina, C1120AAC
        • Research Site
      • CABA, Argentina, C1425HFA
        • Research Site
      • Ciudad de Buenos Aires, Argentina, C1094AAD
        • Research Site
      • Ciudad de Buenos Aires, Argentina, B1704ETD
        • Research Site
      • Rosario, Argentina, S2000PBJ
        • Research Site
      • San Nicolás, Argentina, B2900DMH
        • Research Site
  • Brazil
      • Belo Horizonte, Brazil, 30150-320
        • Research Site
      • Campinas, Brazil, 13060-080
        • Research Site
      • Campinas, Brazil, 13060-904
        • Research Site
      • São Paulo, Brazil, 04266-010
        • Research Site
      • São Paulo, Brazil, 04039-002
        • Research Site
      • São Paulo, Brazil, 01236-030
        • Research Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2V 4J2
        • Research Site
      • Calgary, Alberta, Canada, T3R 1W9
        • Research Site
    • British Columbia
      • Surrey, British Columbia, Canada, V3T 4G8
        • Research Site
      • Vancouver, British Columbia, Canada, V5Y 3W2
        • Research Site
    • Ontario
      • Guelph, Ontario, Canada, N1H 1B1
        • Research Site
      • Hamilton, Ontario, Canada, L8L 5G8
        • Research Site
      • Stouffville, Ontario, Canada, L4A1H2
        • Research Site
      • Toronto, Ontario, Canada, M4G3E8
        • Research Site
    • Quebec
      • Joliette, Quebec, Canada, J6E 6A9
        • Research Site
      • Montreal, Quebec, Canada, H4J 1E3
        • Research Site
  • China
      • Nanjing, China, 210009
        • Research Site
      • Nanjing, China, 210008
        • Research Site
      • Ningbo, China, 315000
        • Research Site
  • Denmark
      • Aarhus N, Denmark, 8200
        • Research Site
      • Gandrup, Denmark, 9362
        • Research Site
      • Herlev, Denmark, 2730
        • Research Site
      • Holbæk, Denmark, 4300
        • Research Site
      • Hvidovre, Denmark, 2650
        • Research Site
      • Odense, Denmark, 5000
        • Research Site
      • Vejle, Denmark, 7100
        • Research Site
  • Israel
      • Holon, Israel, 5822012
        • Research Site
      • Jerusalem, Israel, 00000
        • Research Site
      • Kfar Saba, Israel, 4428164
        • Research Site
      • Petah Tikva, Israel, 49100
        • Research Site
      • Petah Tikva, Israel, 4937211
        • Research Site
      • Tel Aviv, Israel, 64239
        • Research Site
  • Japan
      • Chūōku, Japan, 103-0002
        • Research Site
      • Ichinomiya-shi, Japan, 491-8558
        • Research Site
      • Izunokuni-shi, Japan, 410-2295
        • Research Site
      • Kamakura-shi, Japan, 247-0056
        • Research Site
      • Kawagoe-shi, Japan, 350-0851
        • Research Site
      • Kitakyushu-shi, Japan, 802-0077
        • Research Site
      • Kyoto, Japan, 607-8062
        • Research Site
      • Kyoto, Japan, 612-8555
        • Research Site
      • Mito, Japan, 311-4153
        • Research Site
      • Nishinomiya-shi, Japan, 662-0971
        • Research Site
      • Yokohama, Japan, 230-8765
        • Research Site
      • Ōmihachiman, Japan, 523-0082
        • Research Site
  • Sweden
      • Linköping, Sweden, 58213
        • Research Site
      • Lund, Sweden, 222 22
        • Research Site
      • Mölndal, Sweden, 43153
        • Research Site
      • Stockholm, Sweden, 113 61
        • Research Site
      • Örebro, Sweden, 703 62
        • Research Site
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06100
        • Research Site
      • Ankara, Turkey (Türkiye), 06800
        • Research Site
      • Antalya, Turkey (Türkiye), 07059
        • Research Site
      • Center, Turkey (Türkiye), 23200
        • Research Site
      • Istanbul, Turkey (Türkiye), 34384
        • Research Site
  • United Kingdom
      • Airdrie, United Kingdom, ML6 0JS
        • Research Site
      • Chippenham, United Kingdom, SN14 6GT
        • Research Site
      • Hull, United Kingdom, HU3 2PA
        • Research Site
      • Llandough, United Kingdom, CF64 2XX
        • Research Site
      • Rotherham, United Kingdom, S65 1DA
        • Research Site
  • United States
    • California
      • Escondido, California, United States, 92025
        • Research Site
      • Lincoln, California, United States, 95648
        • Research Site
      • Walnut Creek, California, United States, 94598
        • Research Site
    • Florida
      • Fleming Island, Florida, United States, 32003
        • Research Site
      • Jacksonville, Florida, United States, 32205
        • Research Site
    • Georgia
      • Stockbridge, Georgia, United States, 30281
        • Research Site
      • Woodstock, Georgia, United States, 30189
        • Research Site
    • Illinois
      • Champaign, Illinois, United States, 61822
        • Research Site
      • Chicago, Illinois, United States, 60640
        • Research Site
    • Maryland
      • Beltsville, Maryland, United States, 20705
        • Research Site
      • Oxon Hill, Maryland, United States, 20745
        • Research Site
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Research Site
    • Nevada
      • Las Vegas, Nevada, United States, 89101
        • Research Site
    • New Jersey
      • Somerset, New Jersey, United States, 08873
        • Research Site
    • North Carolina
      • Statesville, North Carolina, United States, 28625
        • Research Site
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Research Site
    • Ohio
      • Columbus, Ohio, United States, 43215
        • Research Site
    • Oregon
      • Portland, Oregon, United States, 97202
        • Research Site
    • Pennsylvania
      • Smithfield, Pennsylvania, United States, 15478
        • Research Site
    • Tennessee
      • Franklin, Tennessee, United States, 37067
        • Research Site
    • Texas
      • Houston, Texas, United States, 77043
        • Research Site
    • Virginia
      • Manassas, Virginia, United States, 20110
        • Research Site
    • Washington
      • Renton, Washington, United States, 98057
        • 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Males & females (inclusive of all gender identities) age ≥18 years
  • BMI ≥ 30 kg/m2 OR BMI ≥ 27 kg/m2 with at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, heart failure, chronic kidney disease, metabolic dysfunction associated steatotic liver disease, osteoarthritis of the knee, or stress urinary incontinence

  • For participants with T2DM only:

    • Diagnosed with T2DM ≥ 90 days prior to Screening
    • HbA1c value at Screening of ≥6.0% (42 mmol/mol) and ≤9.0% (75 mmol/mol) managed with diet and exercise alone or with a stable dose of any oral glycaemic-lowering agent and/or incretin-based medication
  • Receiving a stable dose of incretin- based medications at a dose level that is sufficient for chronic weight management for at least 3 months prior to Screening and Randomisation.
  • Stable body weight (≤ 3% body weight change) for at least 3 months prior to Randomisation
  • History of at least one self-reported unsuccessful attempt to lose body weight in their lifetime

Exclusion Criteria:

  • Obesity primarily caused by other endocrine disorders
  • Type 1 diabetes mellitus

  • Significant hepatobiliary disease and/or any of the following results at Screening:

    • ALT ≥ 3.0 × ULN
    • AST ≥ 3.0 × ULN
    • TBL > 1.5 × ULN (except for cases of known Gilbert's Syndrome)
  • Use of insulin therapy for T2DM within 3 months prior to screening

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: Quadruple

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.
Placebo Comparator: Placebo
Matching placebo
Drug: Placebo
Placebo matching IMP dose injected subcutaneously, once a week.
Experimental: AZD6234
Drug: AZD6234
IMP injected subcutaneously, once a week.

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 68 weeks of treatment
Time Frame: 68 weeks
To evaluate the effect of AZD6234 as compared to placebo as an adjunct to incretin-based therapies in percent body weight change
68 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
Percent change in body weight from baseline at 68 weeks of treatment
Time Frame: 68 weeks
To evaluate the effect of AZD6234 as compared to placebo as an adjunct to incretin-based therapies in percent body weight change in the T2DM and non-T2DM sub-populations separately
68 weeks
Absolute change in weight (kg) from baseline at 68 weeks of treatment
Time Frame: 68 weeks
To evaluate the effect of AZD6234 as compared to placebo as an adjunct to incretin-based therapies on the absolute change in weight in the full population and in the T2DM and non-T2DM sub-populations separately
68 weeks
Achievement of at least 5% body weight loss from baseline at 68 weeks of treatment
Time Frame: 68 weeks
To evaluate the effect of AZD6234 as compared to placebo as an adjunct to incretin-based therapies in body weight loss of at least 5% in the full population and in the T2DM and non T2DM sub-populations separately
68 weeks
Achievement of at least 10% body weight loss from baseline at 68 weeks of treatment
Time Frame: 68 weeks
To evaluate the effect of AZD6234 as compared to placebo as an adjunct to incretin-based therapies in body weight loss of at least 10% in the full population and in the T2DM and non T2DM sub-populations separately
68 weeks
Change in waist circumference (cm) from baseline at 68 weeks of treatment
Time Frame: 68 weeks
To evaluate whether AZD6234 as an adjunct to incretin-based therapies on the waist circumference in the full population and in the T2DM and non-T2DM sub-populations separately
68 weeks
Percent change in triglycerides from baseline at 68 weeks of treatment
Time Frame: 68 weeks
To evaluate the effect of AZD6234 as compared to placebo as an adjunct to incretin-based therapies on triglycerides percent change
68 weeks
Change in systolic blood pressure (mmHg) from baseline at 68 weeks of treatment
Time Frame: 68 weeks
To evaluate the effect of AZD6234 as compared to placebo as an adjunct to incretin-based therapies on the systolic blood pressure change
68 weeks
Change in HbA1c from baseline at 68 weeks of treatment
Time Frame: 68 weeks
For participants with T2DM only: to evaluate the effect of AZD6234 as an adjunct to incretin-based therapies on HbA1c change in the T2DM sub population only
68 weeks

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.
August 21, 2026

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.
August 9, 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.
August 9, 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).
August 10, 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.
August 17, 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.
August 20, 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.
August 20, 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.
August 17, 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.
August 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.
  • D8750C00011
  • 2025-523295-23-00 (Ctis)
  • 159494 (Registry Identifier: IND Number)

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

Yes

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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