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
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)
3 other identifiers
interventional
500
11 countries
88
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2026
88 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2026
CompletedFirst Posted
Study publicly available on registry
August 20, 2026
CompletedStudy Start
First participant enrolled
August 21, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 9, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 9, 2028
August 20, 2026
August 1, 2026
2 years
August 10, 2026
August 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent change in body weight from baseline at 68 weeks of treatment
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 Outcomes (8)
Percent change in body weight from baseline at 68 weeks of treatment
68 weeks
Absolute change in weight (kg) from baseline at 68 weeks of treatment
68 weeks
Achievement of at least 5% body weight loss from baseline at 68 weeks of treatment
68 weeks
Achievement of at least 10% body weight loss from baseline at 68 weeks of treatment
68 weeks
Change in waist circumference (cm) from baseline at 68 weeks of treatment
68 weeks
- +3 more secondary outcomes
Study Arms (2)
AZD6234
EXPERIMENTALAZD6234
Placebo
PLACEBO COMPARATORMatching placebo
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (88)
Research Site
Escondido, California, 92025, United States
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Lincoln, California, 95648, United States
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Walnut Creek, California, 94598, United States
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Fleming Island, Florida, 32003, United States
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Jacksonville, Florida, 32205, United States
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Stockbridge, Georgia, 30281, United States
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Woodstock, Georgia, 30189, United States
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Champaign, Illinois, 61822, United States
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Chicago, Illinois, 60640, United States
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Beltsville, Maryland, 20705, United States
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Oxon Hill, Maryland, 20745, United States
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Kansas City, Missouri, 64111, United States
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Las Vegas, Nevada, 89101, United States
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Somerset, New Jersey, 08873, United States
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Statesville, North Carolina, 28625, United States
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Fargo, North Dakota, 58104, United States
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Columbus, Ohio, 43215, United States
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Portland, Oregon, 97202, United States
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Smithfield, Pennsylvania, 15478, United States
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Franklin, Tennessee, 37067, United States
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Houston, Texas, 77043, United States
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Manassas, Virginia, 20110, United States
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Renton, Washington, 98057, United States
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CABA, C1120AAC, Argentina
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CABA, C1425HFA, Argentina
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Ciudad de Buenos Aires, B1704ETD, Argentina
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Ciudad de Buenos Aires, C1094AAD, Argentina
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Rosario, S2000PBJ, Argentina
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San Nicolás, B2900DMH, Argentina
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Belo Horizonte, 30150-320, Brazil
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Campinas, 13060-080, Brazil
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Campinas, 13060-904, Brazil
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São Paulo, 01236-030, Brazil
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São Paulo, 04039-002, Brazil
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São Paulo, 04266-010, Brazil
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Calgary, Alberta, T2V 4J2, Canada
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Calgary, Alberta, T3R 1W9, Canada
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Surrey, British Columbia, V3T 4G8, Canada
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Vancouver, British Columbia, V5Y 3W2, Canada
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Guelph, Ontario, N1H 1B1, Canada
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Hamilton, Ontario, L8L 5G8, Canada
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Stouffville, Ontario, L4A1H2, Canada
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Toronto, Ontario, M4G3E8, Canada
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Joliette, Quebec, J6E 6A9, Canada
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Montreal, Quebec, H4J 1E3, Canada
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Nanjing, 210008, China
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Nanjing, 210009, China
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Ningbo, 315000, China
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Aarhus N, 8200, Denmark
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Gandrup, 9362, Denmark
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Herlev, 2730, Denmark
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Holbæk, 4300, Denmark
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Hvidovre, 2650, Denmark
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Odense, 5000, Denmark
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Vejle, 7100, Denmark
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Holon, 5822012, Israel
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Jerusalem, 00000, Israel
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Kfar Saba, 4428164, Israel
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Petah Tikva, 49100, Israel
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Petah Tikva, 4937211, Israel
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Tel Aviv, 64239, Israel
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Chūōku, 103-0002, Japan
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Ichinomiya-shi, 491-8558, Japan
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Izunokuni-shi, 410-2295, Japan
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Kamakura-shi, 247-0056, Japan
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Kawagoe-shi, 350-0851, Japan
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Kitakyushu-shi, 802-0077, Japan
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Kyoto, 607-8062, Japan
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Kyoto, 612-8555, Japan
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Mito, 311-4153, Japan
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Nishinomiya-shi, 662-0971, Japan
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Ōmihachiman, 523-0082, Japan
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Yokohama, 230-8765, Japan
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Linköping, 58213, Sweden
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Lund, 222 22, Sweden
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Mölndal, 43153, Sweden
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Örebro, 703 62, Sweden
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Stockholm, 113 61, Sweden
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Ankara, 06100, Turkey (Türkiye)
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Ankara, 06800, Turkey (Türkiye)
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Antalya, 07059, Turkey (Türkiye)
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Center, 23200, Turkey (Türkiye)
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Istanbul, 34384, Turkey (Türkiye)
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Airdrie, ML6 0JS, United Kingdom
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Chippenham, SN14 6GT, United Kingdom
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Hull, HU3 2PA, United Kingdom
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Llandough, CF64 2XX, United Kingdom
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Rotherham, S65 1DA, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2026
First Posted
August 20, 2026
Study Start
August 21, 2026
Primary Completion (Estimated)
August 9, 2028
Study Completion (Estimated)
August 9, 2028
Last Updated
August 20, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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.
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.