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

October 26, 2026 updated by: AstraZeneca

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

The study will evaluate how well AZD6234 works and how safe it is in adults with excess weight or obesity. Efficacy of AZD6234 will be compared to placebo in percent body weight change from baseline at 68 weeks of treatment

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1500

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1120AAC
        • Recruiting
        • Research Site
      • CABA, Argentina, C1425HFA
        • Recruiting
        • Research Site
      • Ciudad de Buenos Aires, Argentina, C1094AAD
        • Recruiting
        • Research Site
      • Mendoza, Argentina, 5500
        • Recruiting
        • Research Site
      • Ramos Mejía, Argentina, B1704ETD
        • Not yet recruiting
        • Research Site
      • Rosario, Argentina, S2000PBJ
        • Recruiting
        • Research Site
      • San Nicolás, Argentina, B2900DMH
        • Not yet recruiting
        • Research Site
  • Australia
      • Botany, Australia, 2019
        • Recruiting
        • Research Site
      • Camberwell, Australia, 3124
        • Recruiting
        • Research Site
      • Charlestown, Australia, 2290
        • Recruiting
        • Research Site
      • Helensvale, Australia, 4212
        • Recruiting
        • Research Site
      • Maroubra, Australia, 2035
        • Recruiting
        • Research Site
      • Waitara, Australia, 2077
        • Recruiting
        • Research Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3R 1W9
        • Recruiting
        • Research Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Y 3W2
        • Recruiting
        • Research Site
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1G 1A7
        • Recruiting
        • Research Site
    • Nova Scotia
      • Truro, Nova Scotia, Canada, B2N 1L2
        • Recruiting
        • Research Site
    • Ontario
      • Hamilton, Ontario, Canada, L8L 5G8
        • Recruiting
        • Research Site
      • Markham, Ontario, Canada, L3S 0A2
        • Recruiting
        • Research Site
      • North York, Ontario, Canada, M6B 3H7
        • Recruiting
        • Research Site
      • Sarnia, Ontario, Canada, N7T 4X3
        • Recruiting
        • Research Site
      • Scarborough Village, Ontario, Canada, M1R 0B1
        • Recruiting
        • Research Site
      • Stoney Creek, Ontario, Canada, L8J 3W2
        • Withdrawn
        • Research Site
      • Stouffville, Ontario, Canada, L4A1H2
        • Recruiting
        • Research Site
      • Toronto, Ontario, Canada, M6G 1M2
        • Recruiting
        • Research Site
      • Toronto, Ontario, Canada, M4G3E8
        • Recruiting
        • Research Site
    • Quebec
      • Joliette, Quebec, Canada, J6E 6A9
        • Recruiting
        • Research Site
      • Montreal, Quebec, Canada, H4N 2W2
        • Recruiting
        • Research Site
      • Montreal, Quebec, Canada, H4J 1E3
        • Recruiting
        • Research Site
      • Québec, Quebec, Canada, G2J 0C4
        • Recruiting
        • Research Site
      • Trois-Rivières, Quebec, Canada, G9A 4P3
        • Recruiting
        • Research Site
  • Chile
      • Concepción, Chile, 4070196
        • Not yet recruiting
        • Research Site
      • Concepción, Chile, 4070060
        • Not yet recruiting
        • Research Site
      • Concepción, Chile, 4070566
        • Not yet recruiting
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      • Iquique, Chile, 1111442
        • Not yet recruiting
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      • Las Condes, Chile, 6770128
        • Not yet recruiting
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      • Providencia, Chile, 7500504
        • Not yet recruiting
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      • Santiago, Chile, 7691236
        • Not yet recruiting
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      • Santiago, Chile, 8331143
        • Not yet recruiting
        • Research Site
      • Santiago, Chile, 7510187
        • Not yet recruiting
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  • China
      • Beijing, China, 100050
        • Not yet recruiting
        • Research Site
      • Cangzhou, China, 061001
        • Not yet recruiting
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      • Changchun, China, 130011
        • Not yet recruiting
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      • Chengdu, China, 610072
        • Not yet recruiting
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      • Chengdu, China, 610021
        • Not yet recruiting
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      • Danyang, China, 212399
        • Not yet recruiting
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      • Ganzhou, China, 341000
        • Not yet recruiting
        • Research Site
      • Guangzhou, China, 510280
        • Not yet recruiting
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      • Huizhou, China, 516002
        • Not yet recruiting
        • Research Site
      • Huzhou, China, 313003
        • Not yet recruiting
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      • Lanzhou, China, 730000
        • Not yet recruiting
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      • Nanjing, China, 210008
        • Not yet recruiting
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      • Nanjing, China, 210009
        • Not yet recruiting
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      • Panjin, China, 124009
        • Not yet recruiting
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      • Suzhou, China, 215006
        • Not yet recruiting
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      • Xianyang, China, 712000
        • Not yet recruiting
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  • Germany
      • Berlin, Germany, 10117
        • Not yet recruiting
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      • Berlin, Germany, 10629
        • Not yet recruiting
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      • Bochum, Germany, 44789
        • Not yet recruiting
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      • Bünde, Germany, 32257
        • Not yet recruiting
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      • Dresden, Germany, 01069
        • Not yet recruiting
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      • Frankfurt, Germany, 60596
        • Not yet recruiting
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      • Frankfurt, Germany, 60590
        • Not yet recruiting
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      • Freiburg im Breisgau, Germany, 79106
        • Not yet recruiting
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      • Göttingen, Germany, 37075
        • Not yet recruiting
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      • Hamburg, Germany, 20095
        • Not yet recruiting
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      • Hamburg, Germany, 20253
        • Not yet recruiting
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      • Hanover, Germany, 30159
        • Not yet recruiting
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      • Homburg, Germany, 66421
        • Not yet recruiting
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      • Jerichow, Germany, 39319
        • Not yet recruiting
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      • Karlsruhe, Germany, 76137
        • Not yet recruiting
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      • Leipzig, Germany, 04177
        • Not yet recruiting
        • Research Site
      • Magdeburg, Germany, 39110
        • Not yet recruiting
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      • Mainz, Germany, 55128
        • Not yet recruiting
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      • München, Germany, 80339
        • Not yet recruiting
        • Research Site
      • Offenbach, Germany, 63065
        • Not yet recruiting
        • Research Site
  • Hungary
      • Balatonfüred, Hungary, 8230
        • Withdrawn
        • Research Site
      • Budapest, Hungary, 1036
        • Withdrawn
        • Research Site
      • Budapest, Hungary, 1024
        • Withdrawn
        • Research Site
      • Budapest, Hungary, 1132
        • Withdrawn
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      • Budapest, Hungary, 1138
        • Withdrawn
        • Research Site
      • Debrecen, Hungary, 4031
        • Withdrawn
        • Research Site
      • Debrecen, Hungary, 4032
        • Withdrawn
        • Research Site
      • Miskolc, Hungary, 3530
        • Withdrawn
        • Research Site
      • Nyíregyháza-Sóstóhegy, Hungary, 4481
        • Withdrawn
        • Research Site
      • Szeged, Hungary, 6725
        • Withdrawn
        • Research Site
      • Szolnok, Hungary, 5000
        • Withdrawn
        • Research Site
  • India
      • Bangalore, India, 560092
        • Not yet recruiting
        • Research Site
      • Indore, India, 452010
        • Not yet recruiting
        • Research Site
      • Kolkata, India, 700014
        • Not yet recruiting
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      • Nagpur, India, 440010
        • Not yet recruiting
        • Research Site
      • Noida, India, 201310
        • Not yet recruiting
        • Research Site
      • Pune, India, 411021
        • Not yet recruiting
        • Research Site
      • Pune, India, 411057
        • Not yet recruiting
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      • Siliguri, India, 734012
        • Not yet recruiting
        • Research Site
      • Visakhapatnam, India, 530002
        • Not yet recruiting
        • Research Site
  • Japan
      • Aira, Japan, 899-5421
        • Recruiting
        • Research Site
      • Chūōku, Japan, 1040031
        • Not yet recruiting
        • Research Site
      • Fukuoka, Japan, 814-0153
        • Recruiting
        • Research Site
      • Hachioji-shi, Japan, 192-0071
        • Not yet recruiting
        • Research Site
      • Izunokuni-shi, Japan, 410-2295
        • Recruiting
        • Research Site
      • Kumamoto, Japan, 860-0833
        • Recruiting
        • Research Site
      • Nagoya, Japan, 451-8511
        • Recruiting
        • Research Site
      • Nagoya, Japan, 467-0806
        • Recruiting
        • Research Site
      • Nerima-ku, Japan, 177-0051
        • Not yet recruiting
        • Research Site
      • Osaka, Japan, 540-0006
        • Recruiting
        • Research Site
      • Osaka, Japan, 537-0014
        • Recruiting
        • Research Site
      • Saga, Japan, 840-8571
        • Recruiting
        • Research Site
      • Sapporo, Japan, 060-0001
        • Not yet recruiting
        • Research Site
      • Shinjuku-ku, Japan, 160-0008
        • Recruiting
        • Research Site
      • Suita-shi, Japan, 565-0853
        • Not yet recruiting
        • Research Site
      • Tanabe-shi, Japan, 646-8558
        • Recruiting
        • Research Site
  • Poland
      • Bialystok, Poland, 15-481
        • Not yet recruiting
        • Research Site
      • Elblag, Poland, 82-300
        • Not yet recruiting
        • Research Site
      • Gdynia, Poland, 81-338
        • Not yet recruiting
        • Research Site
      • Katowice, Poland, 40-081
        • Not yet recruiting
        • Research Site
      • Katowice, Poland, 40-772
        • Not yet recruiting
        • Research Site
      • Krakow, Poland, 30-105
        • Not yet recruiting
        • Research Site
      • Krakow, Poland, 31-271
        • Withdrawn
        • Research Site
      • Legnica, Poland, 59-220
        • Not yet recruiting
        • Research Site
      • Lodz, Poland, 90-338
        • Not yet recruiting
        • Research Site
      • Lodz, Poland, 90-132
        • Not yet recruiting
        • Research Site
      • Poznan, Poland, 60-354
        • Not yet recruiting
        • Research Site
      • Radzionków, Poland, 41-922
        • Not yet recruiting
        • Research Site
      • Warsaw, Poland, 00-719
        • Not yet recruiting
        • Research Site
      • Warsaw, Poland, 03-291
        • Not yet recruiting
        • Research Site
      • Wroclaw, Poland, 53-673
        • Not yet recruiting
        • Research Site
  • Slovakia
      • Bratislava, Slovakia, 831 03
        • Not yet recruiting
        • Research Site
      • Bratislava, Slovakia, 83101
        • Not yet recruiting
        • Research Site
      • Bratislava, Slovakia, 83106
        • Not yet recruiting
        • Research Site
      • Košice, Slovakia, 040 01
        • Not yet recruiting
        • Research Site
      • Košice, Slovakia, 04022
        • Not yet recruiting
        • Research Site
      • Lučenec, Slovakia, 984 01
        • Not yet recruiting
        • Research Site
      • Námestovo, Slovakia, 02901
        • Not yet recruiting
        • Research Site
      • Prievidza, Slovakia, 97101
        • Not yet recruiting
        • Research Site
      • Rožňava, Slovakia, 048 01
        • Not yet recruiting
        • Research Site
      • Trebišov, Slovakia, 075 01
        • Not yet recruiting
        • Research Site
  • South Korea
      • Busan, South Korea, 48108
        • Not yet recruiting
        • Research Site
      • Daegu, South Korea, 42601
        • Not yet recruiting
        • Research Site
      • Daejeon, South Korea, 35233
        • Not yet recruiting
        • Research Site
      • Incheon, South Korea, 403-720
        • Not yet recruiting
        • Research Site
      • Seoul, South Korea, 06351
        • Not yet recruiting
        • Research Site
      • Seoul, South Korea, 01830
        • Not yet recruiting
        • Research Site
      • Seoul, South Korea, 08308
        • Not yet recruiting
        • Research Site
      • Seoul, South Korea, 150-713
        • Not yet recruiting
        • Research Site
      • Seoul, South Korea, 143729
        • Not yet recruiting
        • Research Site
      • Suwon, South Korea, 16247
        • Not yet recruiting
        • Research Site
  • Spain
      • A Coruña, Spain, 15006
        • Not yet recruiting
        • Research Site
      • Alzira (Valencia), Spain, 46600
        • Not yet recruiting
        • Research Site
      • Barcelona, Spain, 08035
        • Not yet recruiting
        • Research Site
      • Castilleja de La Cuesta, Sevilla, Spain, 41950
        • Not yet recruiting
        • Research Site
      • Ferrol (A Coruña), Spain, 15404
        • Not yet recruiting
        • Research Site
      • Lleida, Spain, 25198
        • Not yet recruiting
        • Research Site
      • Málaga, Spain, 29010
        • Not yet recruiting
        • Research Site
      • Oviedo, Spain, 33011
        • Not yet recruiting
        • Research Site
      • Segovia, Spain, 40002
        • Not yet recruiting
        • Research Site
      • Seville, Spain, 41010
        • Not yet recruiting
        • Research Site
  • Taiwan
      • Changhua, Taiwan, 500
        • Not yet recruiting
        • Research Site
      • Kaohsiung City, Taiwan, 80756
        • Recruiting
        • Research Site
      • Taichung, Taiwan, 404
        • Not yet recruiting
        • Research Site
      • Taichung, Taiwan, 402
        • Not yet recruiting
        • Research Site
      • Taichung, Taiwan, 433004
        • Recruiting
        • Research Site
      • Taichung, Taiwan, 407219
        • Recruiting
        • Research Site
      • Tainan, Taiwan, 710
        • Not yet recruiting
        • Research Site
      • Tainan, Taiwan, 704
        • Not yet recruiting
        • Research Site
      • Taipei, Taiwan, 10002
        • Not yet recruiting
        • Research Site
      • Taipei, Taiwan, 11490
        • Not yet recruiting
        • Research Site
      • Zhubei, Taiwan, 302
        • Not yet recruiting
        • Research Site
  • United Kingdom
      • Chippenham, United Kingdom, SN15 2SB
        • Recruiting
        • Research Site
      • Corby, United Kingdom, NN17 2UR
        • Recruiting
        • Research Site
      • Corby, United Kingdom, NN18 9EZ
        • Recruiting
        • Research Site
      • Dunfermline, United Kingdom, KY12 0SU
        • Recruiting
        • Research Site
      • Hull, United Kingdom, HU3 2PA
        • Recruiting
        • Research Site
      • Northwood, United Kingdom, HA6 2RN
        • Recruiting
        • Research Site
  • United States
    • Alabama
      • Fairhope, Alabama, United States, 36532
        • Recruiting
        • Research Site
      • Huntsville, Alabama, United States, 35801
        • Not yet recruiting
        • Research Site
      • Mobile, Alabama, United States, 36608
        • Not yet recruiting
        • Research Site
    • Arizona
      • Mesa, Arizona, United States, 85213
        • Not yet recruiting
        • Research Site
      • Phoenix, Arizona, United States, 85044
        • Recruiting
        • Research Site
      • Tucson, Arizona, United States, 85715
        • Not yet recruiting
        • Research Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Not yet recruiting
        • Research Site
    • California
      • Bakersfield, California, United States, 93309
        • Not yet recruiting
        • Research Site
      • Gardena, California, United States, 90247
        • Recruiting
        • Research Site
      • Lincoln, California, United States, 95648
        • Recruiting
        • Research Site
      • Torrance, California, United States, 90503
        • Not yet recruiting
        • Research Site
      • Walnut Creek, California, United States, 94598
        • Not yet recruiting
        • Research Site
    • Florida
      • Doral, Florida, United States, 33172
        • Not yet recruiting
        • Research Site
      • Fleming Island, Florida, United States, 32003
        • Not yet recruiting
        • Research Site
      • Fort Lauderdale, Florida, United States, 33316
        • Not yet recruiting
        • Research Site
      • Ocoee, Florida, United States, 34761
        • Recruiting
        • Research Site
    • Georgia
      • Woodstock, Georgia, United States, 30189
        • Recruiting
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Not yet recruiting
        • Research Site
      • Melrose Park, Illinois, United States, 60160
        • Not yet recruiting
        • Research Site
      • Oak Brook, Illinois, United States, 60523
        • Not yet recruiting
        • Research Site
    • Iowa
      • Ames, Iowa, United States, 50010
        • Not yet recruiting
        • Research Site
    • Kansas
      • Lenexa, Kansas, United States, 66219
        • Recruiting
        • Research Site
      • Newton, Kansas, United States, 67114
        • Not yet recruiting
        • Research Site
    • Louisiana
      • Monroe, Louisiana, United States, 71201
        • Not yet recruiting
        • Research Site
    • Maryland
      • Beltsville, Maryland, United States, 20705
        • Not yet recruiting
        • Research Site
      • Lanham, Maryland, United States, 20706
        • Not yet recruiting
        • Research Site
      • Oxon Hill, Maryland, United States, 20745
        • Not yet recruiting
        • Research Site
      • Rockville, Maryland, United States, 20852
        • Not yet recruiting
        • Research Site
    • Massachusetts
      • North Dartmouth, Massachusetts, United States, 02747
        • Not yet recruiting
        • Research Site
    • Michigan
      • Farmington Hills, Michigan, United States, 48336
        • Not yet recruiting
        • Research Site
    • Mississippi
      • Fayette, Mississippi, United States, 39069
        • Not yet recruiting
        • Research Site
    • Missouri
      • Kansas City, Missouri, United States, 64114
        • Not yet recruiting
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      • Kansas City, Missouri, United States, 64112
        • Not yet recruiting
        • Research Site
      • St Louis, Missouri, United States, 63141
        • Not yet recruiting
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    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Not yet recruiting
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      • Omaha, Nebraska, United States, 68144
        • Not yet recruiting
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    • New Jersey
      • Eatontown, New Jersey, United States, 07724
        • Not yet recruiting
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      • Somerset, New Jersey, United States, 08873
        • Not yet recruiting
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      • Warren Township, New Jersey, United States, 07059
        • Not yet recruiting
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    • North Carolina
      • Greensboro, North Carolina, United States, 27408
        • Withdrawn
        • Research Site
      • Monroe, North Carolina, United States, 28112
        • Not yet recruiting
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    • Ohio
      • Stow, Ohio, United States, 44224
        • Not yet recruiting
        • Research Site
    • Pennsylvania
      • Scottdale, Pennsylvania, United States, 15683
        • Not yet recruiting
        • Research Site
    • Tennessee
      • Franklin, Tennessee, United States, 37067
        • Recruiting
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      • Jackson, Tennessee, United States, 38305
        • Not yet recruiting
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      • Knoxville, Tennessee, United States, 37938
        • Not yet recruiting
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    • Texas
      • DeSoto, Texas, United States, 75115
        • Not yet recruiting
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      • El Paso, Texas, United States, 79935
        • Not yet recruiting
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      • Houston, Texas, United States, 77099
        • Recruiting
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      • Midland, Texas, United States, 79707
        • Not yet recruiting
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      • Pasadena, Texas, United States, 77504
        • Not yet recruiting
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      • San Antonio, Texas, United States, 78215
        • Not yet recruiting
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      • San Antonio, Texas, United States, 78258
        • Not yet recruiting
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      • San Antonio, Texas, United States, 78207
        • Not yet recruiting
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    • Virginia
      • Manassas, Virginia, United States, 20110
        • Not yet recruiting
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      • Norfolk, Virginia, United States, 23504
        • Recruiting
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males & females (inclusive of all gender identities) age ≥18 years
  • BMI ≥27 kg/m2
  • Diagnosed with T2DM ≥90 days prior to Screening
  • HbA1c value at Screening of ≥6.0% (42 mmol/mol) and ≤10% (86 mmol/mol) managed with diet and exercise alone or with a stable dose of any oral glycaemic-lowering agent (as per local labelling)
  • Stable body weight (≤5% body weight change) for at least 3 months prior to Randomisation
  • History of at least one self-reported unsuccessful attempt to lose body weight in lifetime

Exclusion Criteria:

  • Obesity primarily caused by other endocrine disorders

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

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

    • ALT ≥ 3.0 X ULN
    • AST ≥ 3.0 X ULN
    • TBL > 1.5 X ULN (except for cases of known Gilbert's Syndrome)

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

  • Use of insulin therapy for T2DM within 3 months prior to screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo

Matching placebo
Drug: Placebo

Placebo matching IMP dose injected subcutaneously, once a week.
Experimental: AZD6234 Dose 1

AZD6234 Dose 1
Drug: Lenbelintide

IMP injected subcutaneously, once a week. Unit dose strength as per CSP.

Other Names:
  • AZD6234
Experimental: AZD6234 Dose 2

AZD6234 Dose 2
Drug: Lenbelintide

IMP injected subcutaneously, once a week. Unit dose strength as per CSP.

Other Names:
  • AZD6234

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percent change in body weight from baseline at 68 weeks of treatment.
Time Frame: 68 weeks

To evaluate the effect of AZD6234 compared to placebo in percent body weight change
68 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Absolute change in weight (kg) from baseline at 68 weeks of treatment
Time Frame: 68 weeks

To evaluate the effect of AZD6234 compared to placebo on absolute change in weight
68 weeks
Achievement of at least 5 % body weight loss from baseline at 68 weeks of treatment
Time Frame: 68 weeks

To evaluate the effect of AZD6234 compared to placebo in body weight loss of at least 5%
68 weeks
Achievement of at least 10 % body weight loss from baseline at 68 weeks of treatment
Time Frame: 68 weeks

To evaluate the effect of AZD6234 compared to placebo in body weight loss of at least 10%
68 weeks
Change in haemoglobin A1C from baseline at 68 weeks of treatment
Time Frame: 68 weeks

To evaluate the effect of AZD6234 on haemoglobin A1C change
68 weeks
Change in waist circumference (cm) from baseline at 68 weeks of treatment
Time Frame: 68 weeks

To evaluate the effect of AZD6234 compared to placebo on waist circumference change
68 weeks
Percent change in triglycerides from baseline at 68 weeks of treatment
Time Frame: 68 weeks

To evaluate the effect of AZD6234 compared to placebo on triglycerides percent change
68 weeks
Change in systolic blood pressure (mmHg) from baseline at 68 weeks of treatment
Time Frame: 68 weeks

To evaluate the effect of AZD6234 compared to placebo on systolic blood pressure change
68 weeks
Percent change in fat mass from baseline at 68 weeks of treatment measured by DXA in the DXA Sub-Study subset
Time Frame: 68 weeks

Body Composition Sub-study: To evaluate the effect of AZD6234 compared to placebo on body composition change in the DXA subset of participants
68 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 20, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 9, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 9, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 25, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D8750C00012
  • 159494 (Registry Identifier: IND Number)
  • 2025 (U.S. NIH Grant/Contract)
  • 2025-524616-11 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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