RecruitingRecruiting
A Study to Evaluate Effect of AZD6234 as an Adjunct to Incretin-based Therapies in Adult Participants With Obesity or Overweight With Weight-related Comorbidity With or Without Type 2 Diabetes Mellitus
NCT07776509 · AstraZeneca
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
A Phase III Randomised, Double-Blind, Placebo-Controlled Multicentre Trial to Evaluate the Efficacy and Safety of AZD6234 as an Adjunct to Incretin-based Therapies in Participants With Obesity or Overweight With at Least One Weight-Related Comorbidity With or Without Type 2 Diabetes Mellitus (SELENE 3)
About this study
This is a Phase III, global, randomised, parallel-group, double-blind, multicentre study to assess the efficacy and safety of AZD6234 as an adjunct to incretin-based therapies, compared with placebo in adults with obesity or overweight with at least one weight-related comorbidity and with or without Type 2 Diabetes Mellitus (T2DM). Eligible participants will be randomised to either receive AZD6234 or matching placebo respectively. Study treatment (AZD6234 or placebo) will be added on to the participant's stable dose of background incretin-based therapies.
Eligibility criteria
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
* For participants with T2DM only:
* Diagnosed with T2DM ≥ 90 days prior to Screening
* HbA1c value at Screening of ≥6.0% (42 mmol/mol) and ≤9.0% (75 mmol/mol) managed with diet and exercise alone or with a stable dose of any oral glycaemic-lowering agent and/or incretin-based medication
* Receiving a stable dose of incretin- based medications at a dose level that is sufficient for chronic weight management for at least 3 months prior to Screening and Randomisation.
* Stable body weight (≤ 3% body weight change) for at least 3 months prior to Randomisation
* History of at least one self-reported unsuccessful attempt to lose body weight in their lifetime
Exclusion Criteria:
* Obesity primarily caused by other endocrine disorders
* Type 1 diabetes mellitus
* Significant hepatobiliary disease and/or any of the following results at Screening:
* ALT ≥ 3.0 × ULN
* AST ≥ 3.0 × ULN
* TBL \> 1.5 × ULN (except for cases of known Gilbert's Syndrome)
* Use of insulin therapy for T2DM within 3 months prior to screening
Study design
Enrollment target: 500 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2026-08-24
Estimated completion: 2028-08-09
Last updated: 2026-09-10
Interventions
Drug: AZD6234Drug: Placebo
Primary outcomes
- • Percent change in body weight from baseline at 68 weeks of treatment (68 weeks)
Sponsor
AstraZeneca · industry
Contacts & investigators
ContactAstraZeneca Clinical Study Information Center · contact · information.center@astrazeneca.com · 1-877-240-9479
All locations (96)
Research SiteNot Yet Recruiting
Escondido, California, United States
Research SiteRecruiting
Lincoln, California, United States
Research SiteNot Yet Recruiting
Walnut Creek, California, United States
Research SiteNot Yet Recruiting
Fleming Island, Florida, United States
Research SiteNot Yet Recruiting
Jacksonville, Florida, United States
Research SiteNot Yet Recruiting
Stockbridge, Georgia, United States
Research SiteRecruiting
Woodstock, Georgia, United States
Research SiteNot Yet Recruiting
Champaign, Illinois, United States
Research SiteNot Yet Recruiting
Chicago, Illinois, United States
Research SiteNot Yet Recruiting
Beltsville, Maryland, United States
Research SiteNot Yet Recruiting
Oxon Hill, Maryland, United States
Research SiteNot Yet Recruiting
Kansas City, Missouri, United States
Research SiteNot Yet Recruiting
Las Vegas, Nevada, United States
Research SiteNot Yet Recruiting
Somerset, New Jersey, United States
Research SiteNot Yet Recruiting
Statesville, North Carolina, United States
Research SiteRecruiting
Fargo, North Dakota, United States
Research SiteNot Yet Recruiting
Columbus, Ohio, United States
Research SiteNot Yet Recruiting
Portland, Oregon, United States
Research SiteNot Yet Recruiting
Smithfield, Pennsylvania, United States
Research SiteWithdrawn
Franklin, Tennessee, United States
Research SiteNot Yet Recruiting
Houston, Texas, United States
Research SiteNot Yet Recruiting
Manassas, Virginia, United States
Research SiteWithdrawn
Renton, Washington, United States
Research SiteNot Yet Recruiting
Buenos Aires, Argentina
Research SiteNot Yet Recruiting
CABA, Argentina
Research SiteNot Yet Recruiting
Ciudad de Buenos Aires, Argentina
Research SiteNot Yet Recruiting
Ramos Mejía, Argentina
Research SiteNot Yet Recruiting
Rosario, Argentina
Research SiteNot Yet Recruiting
San Nicolás, Argentina
Research SiteNot Yet Recruiting
Belo Horizonte, Brazil
Research SiteNot Yet Recruiting
Campinas, Brazil
Research SiteNot Yet Recruiting
Campinas, Brazil
Research SiteNot Yet Recruiting
São Paulo, Brazil
Research SiteNot Yet Recruiting
São Paulo, Brazil
Research SiteNot Yet Recruiting
São Paulo, Brazil
Research SiteNot Yet Recruiting
Calgary, Alberta, Canada
Research SiteNot Yet Recruiting
Calgary, Alberta, Canada
Research SiteRecruiting
Surrey, British Columbia, Canada
Research SiteRecruiting
Vancouver, British Columbia, Canada
Research SiteRecruiting
Guelph, Ontario, Canada
Research SiteNot Yet Recruiting
Hamilton, Ontario, Canada
Research SiteRecruiting
Stouffville, Ontario, Canada
Research SiteWithdrawn
Toronto, Ontario, Canada
Research SiteNot Yet Recruiting
Joliette, Quebec, Canada
Research SiteRecruiting
Montreal, Quebec, Canada
Research SiteNot Yet Recruiting
Beijing, China
Research SiteNot Yet Recruiting
Changchun, China
Research SiteNot Yet Recruiting
Chengdu, China
Research SiteNot Yet Recruiting
Chengdu, China
Research SiteNot Yet Recruiting
Guangzhou, China
Research SiteNot Yet Recruiting
Huzhou, China
Research SiteNot Yet Recruiting
Nanjing, China
Research SiteNot Yet Recruiting
Nanjing, China
Research SiteNot Yet Recruiting
Ningbo, China
Research SiteNot Yet Recruiting
Aarhus N, Denmark
Research SiteNot Yet Recruiting
Gandrup, Denmark
Research SiteNot Yet Recruiting
Herlev, Denmark
Research SiteSuspended
Herlev, Denmark
Research SiteNot Yet Recruiting
Holbæk, Denmark
Research SiteNot Yet Recruiting
Hvidovre, Denmark
Research SiteNot Yet Recruiting
Middelfart, Denmark
Research SiteNot Yet Recruiting
Odense, Denmark
Research SiteNot Yet Recruiting
Vejle, Denmark
Research SiteNot Yet Recruiting
Holon, Israel
Research SiteNot Yet Recruiting
Jerusalem, Israel
Research SiteNot Yet Recruiting
Kfar Saba, Israel
Research SiteNot Yet Recruiting
Petah Tikva, Israel
Research SiteNot Yet Recruiting
Petah Tikva, Israel
Research SiteNot Yet Recruiting
Tel Aviv, Israel
Research SiteNot Yet Recruiting
Chūōku, Japan
Research SiteNot Yet Recruiting
Ichinomiya-shi, Japan
Research SiteNot Yet Recruiting
Izunokuni-shi, Japan
Research SiteNot Yet Recruiting
Kamakura-shi, Japan
Research SiteNot Yet Recruiting
Kawagoe-shi, Japan
Research SiteNot Yet Recruiting
Kitakyushu-shi, Japan
Research SiteNot Yet Recruiting
Kyoto, Japan
Research SiteNot Yet Recruiting
Kyoto, Japan
Research SiteNot Yet Recruiting
Mito, Japan
Research SiteNot Yet Recruiting
Nishinomiya-shi, Japan
Research SiteNot Yet Recruiting
Ōmihachiman, Japan
Research SiteNot Yet Recruiting
Yokohama, Japan
Research SiteSuspended
Linköping, Sweden
Research SiteNot Yet Recruiting
Lund, Sweden
Research SiteNot Yet Recruiting
Mölndal, Sweden
Research SiteNot Yet Recruiting
Örebro, Sweden
Research SiteNot Yet Recruiting
Stockholm, Sweden
Research SiteNot Yet Recruiting
Ankara, Turkey (Türkiye)
Research SiteNot Yet Recruiting
Ankara, Turkey (Türkiye)
Research SiteNot Yet Recruiting
Antalya, Turkey (Türkiye)
Research SiteNot Yet Recruiting
Center, Turkey (Türkiye)
Research SiteNot Yet Recruiting
Istanbul, Turkey (Türkiye)
Research SiteNot Yet Recruiting
Airdrie, United Kingdom
Research SiteNot Yet Recruiting
Chippenham, United Kingdom
Research SiteRecruiting
Hull, United Kingdom
Research SiteNot Yet Recruiting
Llandough, United Kingdom
Research SiteNot Yet Recruiting
Rotherham, United Kingdom