A Study to Evaluate Effect of AZD6234 in Adult Participants With Type 2 Diabetes Mellitus and Obesity or Overweight (SELENE 2)

August 20, 2026 updated by: AstraZeneca

A Phase III Randomized, Double-Blind, Placebo-Controlled Multicentre Trial to Evaluate the Efficacy and Safety of AZD6234 in Participants With Type 2 Diabetes Mellitus and Obesity or Overweight (SELENE 2)

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

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a Phase III, global, randomized, parallel-group, double-blind, multicentre study to assess the efficacy and safety of AZD6234 compared with placebo in adults with Type 2 Diabetes Mellitus (T2DM) and obesity or overweight. Eligible participants will be randomized to either receive AZD6234 or matching placebo respectively.

Study Type

Interventional

Enrollment (Estimated)

1500

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

  • Argentina
      • CABA, Argentina, C1120AAC
        • Research Site
      • CABA, Argentina, C1425HFA
        • Research Site
      • Ciudad de Buenos Aires, Argentina, C1094AAD
        • Research Site
      • Mendoza, Argentina, 5500
        • Research Site
      • Ramos Mejía, Argentina, B1704ETD
        • Research Site
      • Rosario, Argentina, S2000PBJ
        • Research Site
      • San Nicolás, Argentina, B2900DMH
        • Research Site
  • Australia
      • Botany, Australia, 2019
        • Research Site
      • Helensvale, Australia, 4212
        • Research Site
      • Kotara, Australia, 2289
        • Research Site
      • Malvern, Australia, 3144
        • Research Site
      • Maroubra, Australia, 2035
        • Research Site
      • Waitara, Australia, 2077
        • Research Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3R 1W9
        • Research Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Y 3W2
        • Research Site
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1G 1A7
        • Research Site
    • Nova Scotia
      • Truro, Nova Scotia, Canada, B2N 1L2
        • Research Site
    • Ontario
      • Hamilton, Ontario, Canada, L8L 5G8
        • Research Site
      • Markham, Ontario, Canada, L3S 0A2
        • Research Site
      • North York, Ontario, Canada, M6B 3H7
        • Research Site
      • Sarnia, Ontario, Canada, N7T 4X3
        • Research Site
      • Scarborough Village, Ontario, Canada, M1R 0B1
        • Research Site
      • Stoney Creek, Ontario, Canada, L8J 3W2
        • Research Site
      • Stouffville, Ontario, Canada, L4A1H2
        • Research Site
      • Toronto, Ontario, Canada, M6G 1M2
        • Research Site
      • Toronto, Ontario, Canada, M4G3E8
        • Research Site
    • Quebec
      • Joliette, Quebec, Canada, J6E 6A9
        • Research Site
      • Montreal, Quebec, Canada, H4N 2W2
        • Research Site
      • Montreal, Quebec, Canada, H4J 1E3
        • Research Site
      • Québec, Quebec, Canada, G2J 0C4
        • Research Site
      • Trois-Rivières, Quebec, Canada, G9A 4P3
        • Research Site
  • Chile
      • Concepción, Chile, 4070196
        • Research Site
      • Concepción, Chile, 4070060
        • Research Site
      • Concepción, Chile, 4070566
        • Research Site
      • Iquique, Chile, 1111442
        • Research Site
      • Providencia, Chile, 7500504
        • Research Site
      • Santiago, Chile
        • Research Site
      • Santiago, Chile, 7691236
        • Research Site
      • Santiago, Chile, 8331143
        • Research Site
      • Santiago, Chile, 7510187
        • Research Site
  • China
      • Beijing, China, 100050
        • Research Site
      • Cangzhou, China, 061001
        • Research Site
      • Changchun, China, 130011
        • Research Site
      • Chengdu, China, 610072
        • Research Site
      • Chengdu, China, 610021
        • Research Site
      • Danyang, China, 212399
        • Research Site
      • Ganzhou, China, 341000
        • Research Site
      • Guangzhou, China, 510280
        • Research Site
      • Huizhou, China, 516002
        • Research Site
      • Huzhou, China, 313003
        • Research Site
      • Lanzhou, China, 730000
        • Research Site
      • Nanjing, China, 210009
        • Research Site
      • Nanjing, China, 210008
        • Research Site
      • Panjin, China, 124009
        • Research Site
      • Suzhou, China, 215006
        • Research Site
      • Xianyang, China, 712000
        • Research Site
  • Germany
      • Berlin, Germany, 10117
        • Research Site
      • Berlin, Germany, 10629
        • Research Site
      • Bochum, Germany, 44789
        • Research Site
      • Bünde, Germany, 32257
        • Research Site
      • Dresden, Germany, 01069
        • Research Site
      • Frankfurt, Germany, 60596
        • Research Site
      • Frankfurt, Germany, 60590
        • Research Site
      • Freiburg im Breisgau, Germany, 79106
        • Research Site
      • Göttingen, Germany, 37075
        • Research Site
      • Hamburg, Germany, 20253
        • Research Site
      • Hamburg, Germany, 20095
        • Research Site
      • Hanover, Germany, 30159
        • Research Site
      • Homburg, Germany, 66421
        • Research Site
      • Jerichow, Germany, 39319
        • Research Site
      • Karlsruhe, Germany, 76137
        • Research Site
      • Leipzig, Germany, 04177
        • Research Site
      • Magdeburg, Germany, 39110
        • Research Site
      • Mainz, Germany, 55128
        • Research Site
      • München, Germany, 80339
        • Research Site
      • Offenbach, Germany, 63065
        • Research Site
  • Hungary
      • Balatonfüred, Hungary, 8230
        • Research Site
      • Budapest, Hungary, 1036
        • Research Site
      • Budapest, Hungary, 1138
        • Research Site
      • Budapest, Hungary, 1132
        • Research Site
      • Budapest, Hungary, 1024
        • Research Site
      • Debrecen, Hungary, 4032
        • Research Site
      • Debrecen, Hungary, 4031
        • Research Site
      • Miskolc, Hungary, 3530
        • Research Site
      • Nyíregyháza-Sóstóhegy, Hungary, 4481
        • Research Site
      • Szeged, Hungary, 6725
        • Research Site
      • Szolnok, Hungary, 5000
        • Research Site
  • India
      • Bangalore, India, 560092
        • Research Site
      • Indore, India, 452010
        • Research Site
      • Kolkata, India, 700014
        • Research Site
      • Nagpur, India, 440010
        • Research Site
      • Pune, India, 411057
        • Research Site
      • Pune, India, 411021
        • Research Site
      • Siliguri, India, 734012
        • Research Site
      • Visakhapatnam, India, 530002
        • Research Site
  • Japan
      • Aira, Japan, 899-5421
        • Research Site
      • Hachioji-shi, Japan, 192-0071
        • Research Site
      • Izunokuni-shi, Japan, 410-2295
        • Research Site
      • Kumamoto, Japan, 860-0833
        • Research Site
      • Nagoya, Japan, 451-8511
        • Research Site
      • Nagoya, Japan, 467-0806
        • Research Site
      • Nerima-ku, Japan, 177-0051
        • Research Site
      • Osaka, Japan, 540-0006
        • Research Site
      • Osaka, Japan, 537-0014
        • Research Site
      • Saga, Japan, 840-8571
        • Research Site
      • Tanabe-shi, Japan, 646-8558
        • Research Site
  • Poland
      • Bialystok, Poland, 15-481
        • Research Site
      • Elblag, Poland, 82-300
        • Research Site
      • Gdynia, Poland, 81-338
        • Research Site
      • Katowice, Poland, 40-081
        • Research Site
      • Katowice, Poland, 40-772
        • Research Site
      • Krakow, Poland, 31-271
        • Research Site
      • Krakow, Poland, 30-105
        • Research Site
      • Legnica, Poland, 59-220
        • Research Site
      • Lodz, Poland, 90-338
        • Research Site
      • Lodz, Poland, 90-132
        • Research Site
      • Poznan, Poland, 60-354
        • Research Site
      • Radzionków, Poland, 41-922
        • Research Site
      • Warsaw, Poland, 03-291
        • Research Site
      • Warsaw, Poland, 00-719
        • Research Site
      • Wroclaw, Poland, 53-673
        • Research Site
  • Slovakia
      • Bratislava, Slovakia, 831 03
        • Research Site
      • Bratislava, Slovakia, 83101
        • Research Site
      • Bratislava, Slovakia, 83106
        • Research Site
      • Košice, Slovakia, 040 01
        • Research Site
      • Košice, Slovakia, 04022
        • Research Site
      • Lučenec, Slovakia, 984 01
        • Research Site
      • Námestovo, Slovakia, 02901
        • Research Site
      • Prievidza, Slovakia, 97101
        • Research Site
      • Rožňava, Slovakia, 048 01
        • Research Site
      • Trebišov, Slovakia, 075 01
        • Research Site
  • South Korea
      • Busan, South Korea, 48108
        • Research Site
      • Daegu, South Korea, 42601
        • Research Site
      • Daejeon, South Korea, 35233
        • Research Site
      • Incheon, South Korea, 403-720
        • Research Site
      • Seoul, South Korea, 08308
        • Research Site
      • Seoul, South Korea, 06351
        • Research Site
      • Seoul, South Korea, 01830
        • Research Site
      • Seoul, South Korea, 143729
        • Research Site
      • Seoul, South Korea, 150-713
        • Research Site
      • Suwon, South Korea, 16247
        • Research Site
  • Spain
      • A Coruña, Spain, 15006
        • Research Site
      • Alzira, Spain, 46600
        • Research Site
      • Barcelona, Spain, 08035
        • Research Site
      • Ferrol, Spain, 15405
        • Research Site
      • Lleida, Spain, 25198
        • Research Site
      • Málaga, Spain, 29010
        • Research Site
      • Oviedo, Spain, 33011
        • Research Site
      • Segovia, Spain, 40002
        • Research Site
      • Seville, Spain, 41010
        • Research Site
      • Seville, Spain, 41950
        • Research Site
  • Taiwan
      • Changhua, Taiwan, 500
        • Research Site
      • Kaohsiung City, Taiwan, 80756
        • Research Site
      • Taichung, Taiwan, 402
        • Research Site
      • Taichung, Taiwan, 404
        • Research Site
      • Taichung, Taiwan, 407219
        • Research Site
      • Taichung, Taiwan, 433004
        • Research Site
      • Tainan, Taiwan, 704
        • Research Site
      • Tainan, Taiwan, 710
        • Research Site
      • Taipei, Taiwan, 10002
        • Research Site
      • Taipei, Taiwan, 11490
        • Research Site
      • Zhubei, Taiwan, 302
        • Research Site
  • United Kingdom
      • Chippenham, United Kingdom, SN15 2SB
        • Research Site
      • Corby, United Kingdom, NN17 2UR
        • Research Site
      • Corby, United Kingdom, NN18 9EZ
        • Research Site
      • Dunfermline, United Kingdom, KY12 0SU
        • Research Site
      • Hull, United Kingdom, HU3 2PA
        • Research Site
      • Northwood, United Kingdom, HA6 2RN
        • Research Site
  • United States
    • Alabama
      • Fairhope, Alabama, United States, 36532
        • Research Site
      • Huntsville, Alabama, United States, 35801
        • Research Site
    • Arizona
      • Mesa, Arizona, United States, 85213
        • Research Site
      • Phoenix, Arizona, United States, 85044
        • Research Site
      • Tucson, Arizona, United States, 85715
        • Research Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Research Site
    • California
      • Bakersfield, California, United States, 93309
        • Research Site
      • Gardena, California, United States, 90247
        • Research Site
      • Lincoln, California, United States, 95648
        • Research Site
      • Torrance, California, United States, 90503
        • Research Site
      • Walnut Creek, California, United States, 94598
        • Research Site
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Research Site
      • Fleming Island, Florida, United States, 32003
        • Research Site
      • Fort Lauderdale, Florida, United States, 33316
        • Research Site
      • Ocoee, Florida, United States, 34761
        • Research Site
    • Georgia
      • Woodstock, Georgia, United States, 30189
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Research Site
      • Melrose Park, Illinois, United States, 60160
        • Research Site
    • Kansas
      • Lenexa, Kansas, United States, 66219
        • Research Site
      • Newton, Kansas, United States, 67114
        • Research Site
    • Louisiana
      • Monroe, Louisiana, United States, 71201
        • Research Site
    • Maryland
      • Beltsville, Maryland, United States, 20705
        • Research Site
      • Lanham, Maryland, United States, 20706
        • Research Site
      • Oxon Hill, Maryland, United States, 20745
        • Research Site
    • Massachusetts
      • North Dartmouth, Massachusetts, United States, 02747
        • Research Site
    • Michigan
      • Farmington Hills, Michigan, United States, 48336
        • Research Site
    • Mississippi
      • Fayette, Mississippi, United States, 39069
        • Research Site
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Research Site
      • St Louis, Missouri, United States, 63141
        • Research Site
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Research Site
      • Omaha, Nebraska, United States, 68144
        • Research Site
    • New Jersey
      • Eatontown, New Jersey, United States, 07724
        • Research Site
      • Somerset, New Jersey, United States, 08873
        • Research Site
      • Warren Township, New Jersey, United States, 07059
        • Research Site
    • North Carolina
      • Greensboro, North Carolina, United States, 27408
        • Research Site
      • Monroe, North Carolina, United States, 28112
        • Research Site
    • Ohio
      • Munroe Falls, Ohio, United States, 44262
        • Research Site
    • Pennsylvania
      • Scottdale, Pennsylvania, United States, 15683
        • Research Site
    • Tennessee
      • Franklin, Tennessee, United States, 37067
        • Research Site
      • Knoxville, Tennessee, United States, 37938
        • Research Site
    • Texas
      • DeSoto, Texas, United States, 75115
        • Research Site
      • El Paso, Texas, United States, 79935
        • Research Site
      • Houston, Texas, United States, 77099
        • Research Site
      • Midland, Texas, United States, 79707
        • Research Site
      • Pasadena, Texas, United States, 77504
        • Research Site
      • San Antonio, Texas, United States, 78251
        • Research Site
      • San Antonio, Texas, United States, 78215
        • Research Site
      • San Antonio, Texas, United States, 78207
        • Research Site
    • Virginia
      • Manassas, Virginia, United States, 20110
        • Research Site
      • Norfolk, Virginia, United States, 23504
        • 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Males & females (inclusive of all gender identities) age ≥18 years
  • BMI ≥27 kg/m2
  • Diagnosed with T2DM ≥90 days prior to Screening
  • HbA1c value at Screening of ≥6.0% (42 mmol/mol) and ≤10% (86 mmol/mol) managed with diet and exercise alone or with a stable dose of any oral glycaemic-lowering agent (as per local labelling)
  • Stable body weight (≤5% 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 lifetime

Exclusion Criteria:

  • Obesity primarily caused by other endocrine disorders
  • Type 1 diabetes mellitus (or any other diabetes mellitus that is not clearly Type 2 diabetes), OR have history of ketoacidosis or hyperosmolar coma/state within 3 months prior to Screening

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

    • ALT ≥ 3.0 X ULN
    • AST ≥ 3.0 X ULN
    • TBL > 1.5 X ULN (except for cases of known Gilbert's Syndrome)
  • Has received treatment with a GLP-1 receptor agonist or GLP-1 containing medication for any indication within 3 months before Randomisation
  • 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
Intervention / Treatment
Placebo Comparator: Placebo
Matching placebo
Drug: Placebo
Placebo matching IMP dose injected subcutaneously, once a week.
Experimental: AZD6234 Dose 1
Drug: AZD6234
IMP injected subcutaneously, once a week. Unit dose strength as per CSP.
Experimental: AZD6234 Dose 2
Drug: AZD6234
IMP injected subcutaneously, once a week. Unit dose strength as per CSP.

What is the study measuring?

Primary Outcome Measures

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 compared to placebo in percent body weight change
68 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absolute change in weight (kg) from baseline at 68 weeks of treatment
Time Frame: 68 weeks
To evaluate the effect of AZD6234 compared to placebo on absolute change in weight
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 compared to placebo in body weight loss of at least 5%
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 compared to placebo in body weight loss of at least 10%
68 weeks
Change in haemoglobin A1C from baseline at 68 weeks of treatment
Time Frame: 68 weeks
To evaluate the effect of AZD6234 on haemoglobin A1C change
68 weeks
Change in waist circumference (cm) from baseline at 68 weeks of treatment
Time Frame: 68 weeks
To evaluate the effect of AZD6234 compared to placebo on waist circumference change
68 weeks
Percent change in triglycerides from baseline at 68 weeks of treatment
Time Frame: 68 weeks
To evaluate the effect of AZD6234 compared to placebo 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 compared to placebo on systolic blood pressure change
68 weeks
Percent change in fat mass from baseline at 68 weeks of treatment measured by DXA in the DXA Sub-Study subset
Time Frame: 68 weeks
Body Composition Sub-study: To evaluate the effect of AZD6234 compared to placebo on body composition change in the DXA subset of participants
68 weeks

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)

August 21, 2026

Primary Completion (Estimated)

August 9, 2028

Study Completion (Estimated)

August 9, 2028

Study Registration Dates

First Submitted

August 6, 2026

First Submitted That Met QC Criteria

August 20, 2026

First Posted (Actual)

August 25, 2026

Study Record Updates

Last Update Posted (Actual)

August 25, 2026

Last Update Submitted That Met QC Criteria

August 20, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D8750C00012
  • 2025 (U.S. NIH Grant/Contract: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 159494 (Registry Identifier: IND Number)
  • 2025-524616-11-00 (Ctis)

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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