A Study to Evaluate Effect of AZD6234 in Adult Participants With Obesity or Overweight With Weight-related Comorbidity Without Type 2 Diabetes Mellitus (SELENE 1)
August 21, 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 Without Type 2 Diabetes Mellitus (SELENE 1)
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
Recruiting
Conditions
Intervention / Treatment
Detailed Description
This is a Phase III, global, randomised, parallel-group, double-blind, multicentre study to assess the efficacy and safety of AZD6234 compared with placebo, administered SC once weekly in adults with obesity or overweight with at least one weight-related comorbidity without T2DM.
Eligible participants will be randomized to either receive AZD6234 or matching placebo respectively.
Study Type
Interventional
Enrollment (Estimated)
2500
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
- Name: AstraZeneca Clinical Study Information Center
- Phone Number: 1-877-240-9479
- Email: information.center@astrazeneca.com
Study Locations
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Buenos Aires, Argentina, C1425AGC
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CABA, Argentina, C1120AAC
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Ciudad de Buenos Aires, Argentina, C1094AAD
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Mendoza, Argentina, 5500
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Ramos Mejía, Argentina, B1704ETD
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Rosario, Argentina, S2000PBJ
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San Nicolás, Argentina, B2900DMH
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Botany, Australia, 2019
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Kotara, Australia, 2289
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Malvern, Australia, 3144
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St Albans, Australia, 3021
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St Leonards, Australia, 2065
- Recruiting
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Waitara, Australia, 2077
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Belo Horizonte, Brazil, 30150-320
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Brasília, Brazil, 71625-009
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Campinas, Brazil, 13060-904
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Campinas, Brazil, 13087-567
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Curitiba, Brazil, 80230-130
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Curitiba, Brazil, 80030-480
- Withdrawn
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Curitiba, Brazil, 80810-040
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Natal, Brazil, 59020-035
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Porto Alegre, Brazil, 90630-165
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Rio de Janeiro, Brazil, 22270-060
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São José dos Campos, Brazil, 12243-280
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São Paulo, Brazil, 04266-010
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Montana, Bulgaria, 3400
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Pleven, Bulgaria, 5800
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Plovdiv, Bulgaria, 4000
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Sofia, Bulgaria, 1618
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Sofia, Bulgaria, 1000
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Sofia, Bulgaria, 1527
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Varna, Bulgaria, 9010
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Yambol, Bulgaria, 8600
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Alberta
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Calgary, Alberta, Canada, T3R 1W9
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British Columbia
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New Westminster, British Columbia, Canada, V3L 3W4
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Surrey, British Columbia, Canada, V3S 2N6
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Victoria, British Columbia, Canada, V8V 4A1
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New Brunswick
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Moncton, New Brunswick, Canada, E1G 1A7
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Nova Scotia
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Truro, Nova Scotia, Canada, B2N 1L2
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Ontario
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Brampton, Ontario, Canada, L6T 0G1
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Guelph, Ontario, Canada, N1H 1B1
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Hamilton, Ontario, Canada, L8L 5G8
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Mississauga, Ontario, Canada, L5K2L3
- Recruiting
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North York, Ontario, Canada, M6B 3H7
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Scarborough Village, Ontario, Canada, M1R 0B1
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Stoney Creek, Ontario, Canada, L8J 3W2
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Stouffville, Ontario, Canada, L4A1H2
- Recruiting
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Toronto, Ontario, Canada, M9V 4B4
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Quebec
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Montreal, Quebec, Canada, H4N 2W2
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Québec, Quebec, Canada, G1V 4T3
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Québec, Quebec, Canada, G2J 0C4
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Saint-Charles-Borromée, Quebec, Canada, J6E 2B4
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Sherbrooke, Quebec, Canada, J1L 0K3
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Beijing, China, 100000
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Cangzhou, China, 061001
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Changchun, China, 130041
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Changchun, China, 130011
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Changsha, China, 410006
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Chengdu, China, 610021
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Danyang, China, 212399
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Ganzhou, China, 341000
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Guiyang, China, 550044
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Hengshui, China, 053099
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Huizhou, China, 516002
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Lanzhou, China, 730000
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Panjin, China, 124009
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Qiqihar, China, 161005
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Shanghai, China, 200032
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Suzhou, China, 215006
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Xiamen, China, 361101
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Xianyang, China, 712000
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Zigong, China, 643000
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Benešov, Czechia, 256 01
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Brandýs nad Labem, Czechia, 250 01
- Withdrawn
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Brno, Czechia, 602 00
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Hodonín, Czechia, 695 01
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Kladno, Czechia, 272 01
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Ostrava, Czechia, 702 00
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Prague, Czechia, 104 00
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Prague, Czechia, 149 00
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Prague, Czechia, 140 00
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Prague, Czechia, 150 00
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Prague, Czechia, 19800
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Prague, Czechia, 116 94
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Štětí, Czechia, 411 08
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Bobigny, France, 93000
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Colmar, France, 68024
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Dijon, France, 21000
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Paris, France, 75900
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Pessac, France, 33604
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Pierre-Bénite, France, 69495
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Thionville, France, 57100
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Toulouse, France, 31059
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Vénissieux, France, 69200
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Berlin, Germany, 10117
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Berlin, Germany, 10787
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Berlin, Germany, 10629
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Bochum, Germany, 44789
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Bünde, Germany, 32257
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Dresden, Germany, 01069
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Frankfurt, Germany, 60596
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Frankfurt, Germany, 60590
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Freiburg im Breisgau, Germany, 79106
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Göttingen, Germany, 37075
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Hamburg, Germany, 20095
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Hamburg, Germany, 20253
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Hanover, Germany, 30159
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Homburg, Germany, 66421
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Jerichow, Germany, 39319
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Karlsruhe, Germany, 76137
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Leipzig, Germany, 04177
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Magdeburg, Germany, 39110
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Mainz, Germany, 55128
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München, Germany, 80339
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München, Germany, 81667
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Offenbach, Germany, 63065
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Schwerin, Germany, 19055
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Wiesbaden, Germany, 65189
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Bhubaneswar, India, 751019
- Suspended
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Coimbatore, India, 641009
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Hyderabad, India, 500048
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Indore, India, 452008
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Jaipur, India, 302001
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Jodhpur, India, 342005
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Kochi, India, 682041
- Suspended
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Kolkata, India, 700014
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Noida, India, 201310
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Pune, India, 411021
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Pune, India, 411057
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Siliguri, India, 734012
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Surat, India, 395002
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Vijayawada, India, 520 008
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Bologna, Italy, 40138
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Milan, Italy, 20138
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Milan, Italy, 20149
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Palermo, Italy, 90127
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Pisa, Italy, 56100
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Roma, Italy, 128
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Rozzano, Italy, 20089
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Sesto San Giovanni, Italy, 20099
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Torino, Italy, 10126
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Chūōku, Japan, 103-0027
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Chūōku, Japan, 103-0025
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Fukuoka, Japan, 812-0025
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Hachioji-shi, Japan, 192-0071
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Osaka, Japan, 540-0001
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Shibuya-ku, Japan, 151-0051
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Takatsuki-shi, Japan, 569-1192
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Bialystok, Poland, 15-481
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Elblag, Poland, 82-300
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Gdynia, Poland, 81-338
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Katowice, Poland, 40-081
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Katowice, Poland, 40-772
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Krakow, Poland, 31-271
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Krakow, Poland, 30-105
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Legnica, Poland, 59-220
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Lodz, Poland, 90-338
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Lodz, Poland, 90-132
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Poznan, Poland, 60-354
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Radzionków, Poland, 41-922
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Warsaw, Poland, 00-719
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Warsaw, Poland, 03-291
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Wroclaw, Poland, 53-673
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Anyang, South Korea, 14068
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Bucheon-si, South Korea, 14754
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Daegu, South Korea, 41944
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Seoul, South Korea, 06591
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Seoul, South Korea, 05505
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Seoul, South Korea, 04763
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Seoul, South Korea, 02841
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Yangsan, South Korea, 50612
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Changhua, Taiwan, 500
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Chiayi City, Taiwan, 600
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Kaohsiung City, Taiwan, 80756
- Recruiting
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New Taipei City, Taiwan, 24352
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Taichung, Taiwan, 40705
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Tainan, Taiwan, 704
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Taipei, Taiwan, 10002
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Taoyuan, Taiwan, 333
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Alabama
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Dothan, Alabama, United States, 36305
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Huntsville, Alabama, United States, 35801
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Arizona
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Mesa, Arizona, United States, 85206
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California
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Escondido, California, United States, 92025
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Florida
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Clearwater, Florida, United States, 33765
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Jacksonville, Florida, United States, 32205
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Georgia
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Stockbridge, Georgia, United States, 30281
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Illinois
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Champaign, Illinois, United States, 61822
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Chicago, Illinois, United States, 60640
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Iowa
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Ames, Iowa, United States, 50010
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Michigan
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Troy, Michigan, United States, 48098
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Missouri
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Jefferson City, Missouri, United States, 65109
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Kansas City, Missouri, United States, 64131
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Montana
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Butte, Montana, United States, 59701
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Nevada
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Las Vegas, Nevada, United States, 89101
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New Jersey
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Jersey City, New Jersey, United States, 07306
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New York
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Cortland, New York, United States, 13045
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North Carolina
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Statesville, North Carolina, United States, 28625
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North Dakota
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Fargo, North Dakota, United States, 58104
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Ohio
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Columbus, Ohio, United States, 43215
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Oklahoma
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Tulsa, Oklahoma, United States, 74133
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Oregon
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Portland, Oregon, United States, 97202
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
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Smithfield, Pennsylvania, United States, 15478
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Tennessee
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Kingsport, Tennessee, United States, 37660
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Texas
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Houston, Texas, United States, 77043
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San Antonio, Texas, United States, 78231
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Sugar Land, Texas, United States, 77478
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Waco, Texas, United States, 76710
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Utah
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Salt Lake City, Utah, United States, 84124
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Virginia
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Arlington, Virginia, United States, 22206
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Washington
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Renton, Washington, United States, 98057
- Withdrawn
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Seattle, Washington, United States, 98104
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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 ≥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
- 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 their lifetime
Exclusion Criteria:
- Obesity primarily caused by other endocrine disorders
- History of Type 1 or Type 2 Diabetes Mellitus, HbA1c ≥6.5% (48 mmol/mol), and/or treatment with glucose-lowering agent(s) within 3 months prior to Screening
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)
- Has received treatment with a GLP-1 receptor agonist or GLP-1 containing medication for any indication within 3 months before Randomisation.
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 |
|---|---|
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Placebo Comparator: Placebo
Matching placebo
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Placebo matching IMP dose injected subcutaneously, once a week.
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Experimental: AZD6234 Dose 1
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IMP injected subcutaneously, once a week.
Unit dose strength as per CSP.
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Experimental: AZD6234 Dose 2
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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
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To evaluate the effect of AZD6234 as 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 as compared to placebo on absolute change in weight
|
68 weeks
|
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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 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 as compared to placebo in body weight loss of at least 10%
|
68 weeks
|
|
Change in waist circumference (cm) from baseline at 68 weeks of treatment
Time Frame: 68 weeks
|
To evaluate the effect of AZD6234 as compared to placebo on waist circumference change
|
68 weeks
|
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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 on triglycerides percent change
|
68 weeks
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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 on systolic blood pressure change
|
68 weeks
|
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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 as 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
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 (Actual)
August 19, 2026
Primary Completion (Estimated)
August 11, 2028
Study Completion (Estimated)
May 21, 2029
Study Registration Dates
First Submitted
August 5, 2026
First Submitted That Met QC Criteria
August 21, 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 21, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D8750C00014
- 2025 (U.S. NIH Grant/Contract: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
- 159494 (Registry Identifier: IND Number)
- 2025-523379-41-00 (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
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