Obesity or OverweightPhase 3SELENE 1NCT07784725

A Study to Evaluate Effect of AZD6234 in Adult Participants With Obesity or Overweight With Weight-related Comorbidity Without Type 2 Diabetes Mellitus

A Phase 3 study testing Lenbelintide in people with Obesity or Overweight, run by AstraZeneca at 220 sites in 16 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Obesity or Overweight
What is being tested?: Lenbelintide
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 2,500 participants
Where: 220 sitesin 16 countries
Study dates: 19 Aug 2026to 21 May 2029
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

220 sites in 16 countries. Contact the study team or a site near you to ask about taking part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

Country

City, postcode or hospital

Sites recruiting now only

220 sites in 16 countries

United States41 sites, 40 recruiting

Research Site
Ames, Iowa, 50010
Recruiting
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Arlington, Virginia, 22206
Not yet recruiting
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Bridgeport, Connecticut, 06606
Not yet recruiting
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Butte, Montana, 59701
Not yet recruiting
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Champaign, Illinois, 61822
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Chicago, Illinois, 60640
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Clearwater, Florida, 33765
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Columbus, Ohio, 43215
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Cortland, New York, 13045
Not yet recruiting
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Dothan, Alabama, 36305
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El Dorado, Kansas, 67042
Not yet recruiting
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Escondido, California, 92025
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Fargo, North Dakota, 58104
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Houston, Texas, 77043
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Huntsville, Alabama, 35801
Not yet recruiting
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Jacksonville, Florida, 32205
Not yet recruiting
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Jefferson City, Missouri, 65109
Not yet recruiting
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Jersey City, New Jersey, 07306
Not yet recruiting
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Kansas City, Missouri, 64131
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Kingsport, Tennessee, 37660
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Las Vegas, Nevada, 89101
Not yet recruiting
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Maumee, Ohio, 43537
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Memphis, Tennessee, 38119
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Mesa, Arizona, 85206
Not yet recruiting
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Owensboro, Kentucky, 42301
Not yet recruiting
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Philadelphia, Pennsylvania, 19107
Recruiting
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Portland, Oregon, 97202
Not yet recruiting
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Renton, Washington, 98057
Withdrawn
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Rochester, New York, 14609
Not yet recruiting
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Rocky Mount, North Carolina, 27804
Recruiting
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Salt Lake City, Utah, 84124
Not yet recruiting
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San Antonio, Texas, 78231
Not yet recruiting
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Seattle, Washington, 98104
Not yet recruiting
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Smithfield, Pennsylvania, 15478
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Statesville, North Carolina, 28625
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Stockbridge, Georgia, 30281
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Sugar Land, Texas, 77478
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Troy, Michigan, 48098
Not yet recruiting
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Tulsa, Oklahoma, 74133
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Waco, Texas, 76710
Recruiting
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Wilmington, North Carolina, 28401
Not yet recruiting

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Germany24 sites, 24 recruiting

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Berlin, 10117
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Berlin, 10629
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Berlin, 10787
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Bochum, 44789
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Bünde, 32257
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Dresden, 01069
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Frankfurt, 60590
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Frankfurt, 60596
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Freiburg im Breisgau, 79106
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Göttingen, 37075
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Hamburg, 20095
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Hamburg, 20253
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Hanover, 30159
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Homburg, 66421
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Jerichow, 39319
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Karlsruhe, 76137
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Leipzig, 04177
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Magdeburg, 39110
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Mainz, 55128
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München, 80339
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München, 81667
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Offenbach, 63065
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Schwerin, 19055
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Wiesbaden, 65189
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Canada20 sites, 19 recruiting

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Brampton, Ontario, L6T 0G1
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Calgary, Alberta, T3R 1W9
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Guelph, Ontario, N1H 1B1
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Hamilton, Ontario, L8L 5G8
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Mississauga, Ontario, L5K2L3
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Moncton, New Brunswick, E1G 1A7
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Montreal, Quebec, H4N 2W2
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New Westminster, British Columbia, V3L 3W4
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North York, Ontario, M6B 3H7
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Québec, Quebec, G1V 4T3
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Québec, Quebec, G2J 0C4
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Saint-Charles-Borromée, Quebec, J6E 2B4
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Scarborough Village, Ontario, M1R 0B1
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Sherbrooke, Quebec, J1L 0K3
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Stoney Creek, Ontario, L8J 3W2
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Stouffville, Ontario, L4A1H2
Recruiting
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Surrey, British Columbia, V3S 2N6
Withdrawn
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Toronto, Ontario, M9V 4B4
Recruiting
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Truro, Nova Scotia, B2N 1L2
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Victoria, British Columbia, V8V 4A1
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China19 sites, 19 recruiting

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Beijing, 100000
Not yet recruiting
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Cangzhou, 061001
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Changchun, 130011
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Changchun, 130041
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Changsha, 410006
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Chengdu, 610021
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Danyang, 212399
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Ganzhou, 341000
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Guiyang, 550044
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Hengshui, 053099
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Huizhou, 516002
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Lanzhou, 730000
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Panjin, 124009
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Qiqihar, 161005
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Shanghai, 200032
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Suzhou, 215006
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Xiamen, 361101
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Xianyang, 712000
Not yet recruiting
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Zigong, 643000
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Poland15 sites, 14 recruiting

Research Site
Bialystok, 15-481
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Elblag, 82-300
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Gdynia, 81-338
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Katowice, 40-081
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Katowice, 40-772
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Krakow, 30-105
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Krakow, 31-271
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Legnica, 59-220
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Lodz, 90-132
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Lodz, 90-338
Not yet recruiting
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Poznan, 60-354
Not yet recruiting
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Radzionków, 41-922
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Warsaw, 00-719
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Warsaw, 03-291
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Wroclaw, 53-673
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India14 sites, 12 recruiting

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Bhubaneswar, 751019
Suspended
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Coimbatore, 641009
Not yet recruiting
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Hyderabad, 500048
Not yet recruiting
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Indore, 452008
Not yet recruiting
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Jaipur, 302001
Not yet recruiting
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Jodhpur, 342005
Not yet recruiting
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Kochi, 682041
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Kolkata, 700014
Not yet recruiting
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Noida, 201310
Not yet recruiting
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Pune, 411021
Not yet recruiting
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Pune, 411057
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Siliguri, 734012
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Surat, 395002
Not yet recruiting
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Vijayawada, 520 008
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Czechia13 sites, 9 recruiting

Research Site
Benešov, 256 01
Not yet recruiting
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Brandýs nad Labem, 250 01
Withdrawn
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Brno, 602 00
Suspended
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Hodonín, 695 01
Not yet recruiting
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Kladno, 272 01
Suspended
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Ostrava, 702 00
Not yet recruiting
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Prague, 104 00
Not yet recruiting
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Prague, 116 94
Suspended
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Prague, 140 00
Not yet recruiting
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Prague, 149 00
Not yet recruiting
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Prague, 150 00
Recruiting
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Prague, 19800
Not yet recruiting
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Štětí, 411 08
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Brazil12 sites, 11 recruiting

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Belo Horizonte, 30150-320
Not yet recruiting
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Brasília, 71625-009
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Campinas, 13060-803
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Campinas, 13087-567
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Curitiba, 80030-480
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Curitiba, 80230-130
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Curitiba, 80810-040
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Natal, 59020-500
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Porto Alegre, 90410-000
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Rio de Janeiro, 22270-060
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São José dos Campos, 12243-280
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São Paulo, 04266-010
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France9 sites, 9 recruiting

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Bobigny, 93000
Not yet recruiting
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Colmar, 68024
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Dijon, 21000
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Paris, 75900
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Pessac, 33604
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Pierre-Bénite, 69495
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Thionville, 57100
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Toulouse, 31059
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Italy9 sites, 9 recruiting

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Milan, 20149
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Palermo, 90127
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Pisa, 56100
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Seoul, 02841
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Tainan, 704
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Japan7 sites, 7 recruiting

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About this study

Official title: 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)

Read the 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.

Conditions: Obesity or Overweight
Being tested: Lenbelintide, Placebo
Keywords: Obesity, Overweight, AZD6234, Lenbelintide
Medical subject headings: Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LenbelintideDrug
Also called AZD6234
IMP injected subcutaneously, once a week. Unit dose strength as per CSP.
PlaceboDrug
Placebo matching IMP dose injected subcutaneously, once a week.

Study groups in NCT07784725
Study group	Role	What they receive
AZD6234 Dose 1	Experimental	AZD6234 Dose 1 Receives: Drug: Lenbelintide
AZD6234 Dose 2	Experimental	AZD6234 Dose 2 Receives: Drug: Lenbelintide
Placebo	Placebo comparator	Matching placebo Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent change in body weight from baseline at 68 weeks of treatment
To evaluate the effect of AZD6234 as compared to placebo in percent body weight change
Measured: 68 weeks

Secondary outcomes (7)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Aug 202621 May 2029

First posted25 Aug 2026
Study start19 Aug 2026
Primary completion11 Aug 2028 (estimated)
Study completion21 May 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Obesity or OverweightStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: International, multi-centre, randomised, double-blind, placebo-controlled, parallel-group
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 2,500 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07784725
Sponsor's protocol ID: D8750C00014
Other IDs: 2025-523379-41-00, 159494, 2025
Acronym: SELENE 1
Status last verified: Oct 2026
First submitted: 5 Aug 2026
Last updated: 30 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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.

Study at a glance

From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT07784725
Acronym / sponsor ID: SELENE 1 / D8750C00014
Conditions: Obesity or Overweight
Keywords: Obesity, Overweight, AZD6234, Lenbelintide
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 2,500 participants (estimated)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 19 Aug 2026 (actual)
Primary completion: 11 Aug 2028 (estimated)
Study completion: 21 May 2029 (estimated)
First posted: 25 Aug 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3
Model description: International, multi-centre, randomised, double-blind, placebo-controlled, parallel-group

Arm	Type	Receives
AZD6234 Dose 1	Experimental	Drug: LenbelintideAZD6234 Dose 1
AZD6234 Dose 2	Experimental	Drug: LenbelintideAZD6234 Dose 2
Placebo	Placebo comparator	Drug: PlaceboMatching placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (7 listed)

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:
Has received treatment with a GLP-1 receptor agonist or GLP-1 containing medication for any indication within 3 months before Randomisation.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LenbelintideAlso: AZD6234IMP injected subcutaneously, once a week. Unit dose strength as per CSP.	Drug	AZD6234 Dose 1, AZD6234 Dose 2
PlaceboPlacebo matching IMP dose injected subcutaneously, once a week.	Drug	Placebo

Primary outcome

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 in percent body weight change

7 secondary outcomes

Absolute change in weight (kg) from baseline at 68 weeks of treatment
Time frame: 68 weeks
Achievement of at least 5 % body weight loss from baseline at 68 weeks of treatment
Time frame: 68 weeks
Achievement of at least 10% body weight loss from baseline at 68 weeks of treatment
Time frame: 68 weeks
Change in waist circumference (cm) from baseline at 68 weeks of treatment
Time frame: 68 weeks
Percent change in triglycerides from baseline at 68 weeks of treatment
Time frame: 68 weeks
Change in systolic blood pressure (mmHg) from baseline at 68 weeks of treatment
Time frame: 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

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

220 sites in 16 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lenbelintide in people with Obesity or Overweight, run by AstraZeneca at 220 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 220 sites in United States, Germany, Canada, China, Poland and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent change in body weight from baseline at 68 weeks of treatment (time frame: 68 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07784725.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.