A Study to Evaluate Effect of AZD6234 in Adult Participants With Type 2 Diabetes Mellitus and Obesity or Overweight
SELENE 2
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)
4 other identifiers
interventional
1,500
16 countries
218
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 P75+ for phase_3
Started Aug 2026
218 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2026
CompletedStudy Start
First participant enrolled
August 21, 2026
CompletedFirst Posted
Study publicly available on registry
August 25, 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 25, 2026
August 1, 2026
2 years
August 6, 2026
August 20, 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 compared to placebo in percent body weight change
68 weeks
Secondary Outcomes (8)
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 haemoglobin A1C 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 (3)
AZD6234 Dose 1
EXPERIMENTALAZD6234 Dose 1
AZD6234 Dose 2
EXPERIMENTALAZD6234 Dose 2
Placebo
PLACEBO COMPARATORMatching placebo
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (218)
Research Site
Fairhope, Alabama, 36532, United States
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Huntsville, Alabama, 35801, United States
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Mesa, Arizona, 85213, United States
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Phoenix, Arizona, 85044, United States
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Tucson, Arizona, 85715, United States
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Little Rock, Arkansas, 72205, United States
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Bakersfield, California, 93309, United States
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Gardena, California, 90247, United States
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Lincoln, California, 95648, United States
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Torrance, California, 90503, United States
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Walnut Creek, California, 94598, United States
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Coral Gables, Florida, 33134, United States
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Fleming Island, Florida, 32003, United States
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Fort Lauderdale, Florida, 33316, United States
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Ocoee, Florida, 34761, United States
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Woodstock, Georgia, 30189, United States
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Chicago, Illinois, 60640, United States
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Melrose Park, Illinois, 60160, United States
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Lenexa, Kansas, 66219, United States
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Newton, Kansas, 67114, United States
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Monroe, Louisiana, 71201, United States
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Beltsville, Maryland, 20705, United States
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Lanham, Maryland, 20706, United States
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Oxon Hill, Maryland, 20745, United States
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North Dartmouth, Massachusetts, 02747, United States
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Farmington Hills, Michigan, 48336, United States
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Fayette, Mississippi, 39069, United States
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Kansas City, Missouri, 64111, United States
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St Louis, Missouri, 63141, United States
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Omaha, Nebraska, 68114, United States
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Omaha, Nebraska, 68144, United States
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Eatontown, New Jersey, 07724, United States
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Somerset, New Jersey, 08873, United States
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Warren Township, New Jersey, 07059, United States
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Greensboro, North Carolina, 27408, United States
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Monroe, North Carolina, 28112, United States
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Munroe Falls, Ohio, 44262, United States
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Scottdale, Pennsylvania, 15683, United States
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Franklin, Tennessee, 37067, United States
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Knoxville, Tennessee, 37938, United States
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DeSoto, Texas, 75115, United States
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El Paso, Texas, 79935, United States
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Houston, Texas, 77099, United States
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Midland, Texas, 79707, United States
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Pasadena, Texas, 77504, United States
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San Antonio, Texas, 78207, United States
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San Antonio, Texas, 78215, United States
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San Antonio, Texas, 78251, United States
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Manassas, Virginia, 20110, United States
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Norfolk, Virginia, 23504, United States
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CABA, C1120AAC, Argentina
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CABA, C1425HFA, Argentina
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Ciudad de Buenos Aires, C1094AAD, Argentina
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Mendoza, 5500, Argentina
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Ramos Mejía, B1704ETD, Argentina
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Rosario, S2000PBJ, Argentina
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San Nicolás, B2900DMH, Argentina
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Botany, 2019, Australia
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Helensvale, 4212, Australia
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Kotara, 2289, Australia
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Malvern, 3144, Australia
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Maroubra, 2035, Australia
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Waitara, 2077, Australia
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Calgary, Alberta, T3R 1W9, Canada
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Vancouver, British Columbia, V5Y 3W2, Canada
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Moncton, New Brunswick, E1G 1A7, Canada
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Truro, Nova Scotia, B2N 1L2, Canada
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Hamilton, Ontario, L8L 5G8, Canada
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Markham, Ontario, L3S 0A2, Canada
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North York, Ontario, M6B 3H7, Canada
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Sarnia, Ontario, N7T 4X3, Canada
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Scarborough Village, Ontario, M1R 0B1, Canada
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Stoney Creek, Ontario, L8J 3W2, Canada
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Stouffville, Ontario, L4A1H2, Canada
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Toronto, Ontario, M4G3E8, Canada
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Toronto, Ontario, M6G 1M2, Canada
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Joliette, Quebec, J6E 6A9, Canada
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Montreal, Quebec, H4J 1E3, Canada
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Montreal, Quebec, H4N 2W2, Canada
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Québec, Quebec, G2J 0C4, Canada
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Trois-Rivières, Quebec, G9A 4P3, Canada
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Concepción, 4070060, Chile
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Concepción, 4070196, Chile
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Concepción, 4070566, Chile
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Iquique, 1111442, Chile
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Providencia, 7500504, Chile
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Santiago, 7510187, Chile
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Santiago, 7691236, Chile
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Santiago, 8331143, Chile
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Santiago, Chile
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Beijing, 100050, China
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Cangzhou, 061001, China
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Changchun, 130011, China
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Chengdu, 610021, China
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Chengdu, 610072, China
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Danyang, 212399, China
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Ganzhou, 341000, China
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Guangzhou, 510280, China
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Huizhou, 516002, China
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Huzhou, 313003, China
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Lanzhou, 730000, China
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Nanjing, 210008, China
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Nanjing, 210009, China
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Panjin, 124009, China
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Suzhou, 215006, China
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Xianyang, 712000, China
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Berlin, 10117, Germany
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Berlin, 10629, Germany
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Bochum, 44789, Germany
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Bünde, 32257, Germany
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Dresden, 01069, Germany
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Frankfurt, 60590, Germany
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Frankfurt, 60596, Germany
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Freiburg im Breisgau, 79106, Germany
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Göttingen, 37075, Germany
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Hamburg, 20095, Germany
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Hamburg, 20253, Germany
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Hanover, 30159, Germany
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Homburg, 66421, Germany
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Jerichow, 39319, Germany
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Karlsruhe, 76137, Germany
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Leipzig, 04177, Germany
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Magdeburg, 39110, Germany
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Mainz, 55128, Germany
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München, 80339, Germany
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Offenbach, 63065, Germany
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Balatonfüred, 8230, Hungary
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Budapest, 1024, Hungary
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Budapest, 1036, Hungary
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Budapest, 1132, Hungary
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Budapest, 1138, Hungary
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Debrecen, 4031, Hungary
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Debrecen, 4032, Hungary
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Miskolc, 3530, Hungary
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Nyíregyháza-Sóstóhegy, 4481, Hungary
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Szeged, 6725, Hungary
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Szolnok, 5000, Hungary
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Bangalore, 560092, India
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Indore, 452010, India
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Kolkata, 700014, India
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Nagpur, 440010, India
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Pune, 411021, India
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Pune, 411057, India
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Siliguri, 734012, India
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Visakhapatnam, 530002, India
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Aira, 899-5421, Japan
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Hachioji-shi, 192-0071, Japan
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Izunokuni-shi, 410-2295, Japan
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Kumamoto, 860-0833, Japan
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Nagoya, 451-8511, Japan
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Nagoya, 467-0806, Japan
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Nerima-ku, 177-0051, Japan
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Osaka, 537-0014, Japan
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Osaka, 540-0006, Japan
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Saga, 840-8571, Japan
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Tanabe-shi, 646-8558, Japan
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Bialystok, 15-481, Poland
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Elblag, 82-300, Poland
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Gdynia, 81-338, Poland
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Katowice, 40-081, Poland
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Katowice, 40-772, Poland
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Krakow, 30-105, Poland
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Krakow, 31-271, Poland
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Legnica, 59-220, Poland
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Lodz, 90-132, Poland
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Lodz, 90-338, Poland
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Poznan, 60-354, Poland
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Radzionków, 41-922, Poland
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Warsaw, 00-719, Poland
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Warsaw, 03-291, Poland
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Wroclaw, 53-673, Poland
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Bratislava, 831 03, Slovakia
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Bratislava, 83101, Slovakia
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Bratislava, 83106, Slovakia
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Košice, 040 01, Slovakia
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Košice, 04022, Slovakia
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Lučenec, 984 01, Slovakia
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Námestovo, 02901, Slovakia
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Prievidza, 97101, Slovakia
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Rožňava, 048 01, Slovakia
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Trebišov, 075 01, Slovakia
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Busan, 48108, South Korea
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Daegu, 42601, South Korea
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Daejeon, 35233, South Korea
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Incheon, 403-720, South Korea
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Seoul, 01830, South Korea
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Seoul, 06351, South Korea
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Seoul, 08308, South Korea
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Seoul, 143729, South Korea
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Seoul, 150-713, South Korea
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Suwon, 16247, South Korea
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A Coruña, 15006, Spain
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Alzira, 46600, Spain
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Barcelona, 08035, Spain
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Ferrol, 15405, Spain
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Lleida, 25198, Spain
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Málaga, 29010, Spain
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Oviedo, 33011, Spain
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Segovia, 40002, Spain
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Seville, 41010, Spain
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Seville, 41950, Spain
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Changhua, 500, Taiwan
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Kaohsiung City, 80756, Taiwan
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Taichung, 402, Taiwan
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Taichung, 404, Taiwan
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Taichung, 407219, Taiwan
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Taichung, 433004, Taiwan
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Tainan, 704, Taiwan
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Tainan, 710, Taiwan
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Taipei, 10002, Taiwan
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Taipei, 11490, Taiwan
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Zhubei, 302, Taiwan
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Chippenham, SN15 2SB, United Kingdom
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Corby, NN17 2UR, United Kingdom
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Corby, NN18 9EZ, United Kingdom
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Dunfermline, KY12 0SU, United Kingdom
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Hull, HU3 2PA, United Kingdom
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Northwood, HA6 2RN, 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 6, 2026
First Posted
August 25, 2026
Study Start
August 21, 2026
Primary Completion (Estimated)
August 9, 2028
Study Completion (Estimated)
August 9, 2028
Last Updated
August 25, 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.