Tests lenbelintide added to weight-loss medicines in adults with excess weight
Tests lenbelintide against placebo alongside incretin medicines in adults with obesity or overweight.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Chūōku, Ichinomiya-shi, Izunokuni-shi, Kamakura-shi, Kawagoe-shi, Kitakyushu-shi, Kyoto, Mito, Nishinomiya-shi, Ōmihachiman, and Yokohama, JapanSee the 11 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with obesity or overweight who already take a stable dose of an incretin-based weight medicine. People with type 2 diabetes can also join.
- Age
- 18 years or older
- Sex
- All sexes and gender identities can join.
- Disease stage
- BMI of 30 kg/m2 or more, or BMI of 27 kg/m2 or more with at least one weight-related condition. Examples are high blood pressure, sleep apnoea or knee osteoarthritis. People with type 2 diabetes must have had it for at least 90 days and have HbA1c of 6.0% (42 mmol/mol) to 9.0% (75 mmol/mol).
- Earlier treatment
- A stable dose of an incretin-based medicine, enough for weight management, for at least 3 months. Stable body weight (3% change or less) for at least 3 months. At least one self-reported failed attempt to lose weight.
- Biomarker or test result
- For people with type 2 diabetes: HbA1c of 6.0% (42 mmol/mol) to 9.0% (75 mmol/mol) at Screening.
Main reasons for not taking part
- Obesity mainly caused by other hormone disorders
- Type 1 diabetes
- Significant liver or bile duct disease, or ALT or AST of 3.0 × ULN or more
- Bilirubin above 1.5 × ULN (except known Gilbert's Syndrome)
- Insulin for type 2 diabetes within 3 months before screening
Read by machine on 10 November 2026.
Where in Japan
- ChūōkuHospital not named in the registryTaking people
- Ichinomiya-shiHospital not named in the registryTaking people
- Izunokuni-shiHospital not named in the registryTaking people
- Kamakura-shiHospital not named in the registryTaking people
- Kawagoe-shiHospital not named in the registryTaking people
- Kitakyushu-shiHospital not named in the registryTaking people
- KyotoHospital not named in the registryTaking people
- MitoHospital not named in the registryTaking people
- Nishinomiya-shiHospital not named in the registryTaking people
- ŌmihachimanHospital not named in the registryTaking people
- YokohamaHospital not named in the registryTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- AstraZeneca
- Trial code
- NCT07776509EU 2025-523295-23-00
- Record updated
- 9 November 2026
- Original description
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 full original descriptionShow less
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)
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.
Inclusion: 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: Use of insulin therapy for T2DM within 3 months prior to screening; 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).