> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-evaluate-effect-of-azd6234-in-adult-participants-d18dd33a-c8bc-4546-ada9-caf290d7ddf2 > Record changed: 2026-11-04 # A Study to Evaluate Effect of AZD6234 in Adult Participants With Type 2 Diabetes Mellitus and Obesity or Overweight NCT07784270 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784270) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784270) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784270) Participants 1,500 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784270) Lead sponsor AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784270) Start date 2026-08-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784270) Number of sites 230 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784270) ## Title and summary **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784270) **Acronym** SELENE 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784270) **Short title** A Study to Evaluate Effect of AZD6234 in Adult Participants With Type 2 Diabetes Mellitus and Obesity or Overweight Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784270) **Official title** 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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784270) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784270) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784270) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784270) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784270) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784270) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784270) ## Dates **Completion date** 2028-08-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784270) **First posted** 2026-08-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784270) **Registry last updated** 2026-10-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784270) **Primary completion date** 2028-08-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784270) **Start date** 2026-08-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784270) ## Size and sites **Participants** 1,500 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784270) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784270) **Planned participants** 1,500 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784270) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784270) **Number of sites** 230 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784270) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784270) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784270) **Lead sponsor** AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784270) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784270) ## Identifiers **Registry ID** NCT07784270 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784270) **ClinicalTrials.gov ID** NCT07784270 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784270) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784270) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784270) ## Outcomes ### Primary outcomes 1. Percent change in body weight from baseline at 68 weeks of treatment. Timeframe: 68 weeks To evaluate the effect of AZD6234 compared to placebo in percent body weight change ### Secondary outcomes 1. Absolute change in weight (kg) from baseline at 68 weeks of treatment Timeframe: 68 weeks To evaluate the effect of AZD6234 compared to placebo on absolute change in weight 2. Achievement of at least 5 % body weight loss from baseline at 68 weeks of treatment Timeframe: 68 weeks To evaluate the effect of AZD6234 compared to placebo in body weight loss of at least 5% 3. Achievement of at least 10 % body weight loss from baseline at 68 weeks of treatment Timeframe: 68 weeks To evaluate the effect of AZD6234 compared to placebo in body weight loss of at least 10% 4. Change in haemoglobin A1C from baseline at 68 weeks of treatment Timeframe: 68 weeks To evaluate the effect of AZD6234 on haemoglobin A1C change 5. Change in waist circumference (cm) from baseline at 68 weeks of treatment Timeframe: 68 weeks To evaluate the effect of AZD6234 compared to placebo on waist circumference change 6. Percent change in triglycerides from baseline at 68 weeks of treatment Timeframe: 68 weeks To evaluate the effect of AZD6234 compared to placebo on triglycerides percent change 7. Change in systolic blood pressure (mmHg) from baseline at 68 weeks of treatment Timeframe: 68 weeks To evaluate the effect of AZD6234 compared to placebo on systolic blood pressure change 8. Percent change in fat mass from baseline at 68 weeks of treatment measured by DXA in the DXA Sub-Study subset Timeframe: 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 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784270) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784270) ## Sites - Research SiteFairhope, United StatesRecruiting - Research SiteHuntsville, United StatesNot yet recruiting - Research SiteMobile, United StatesNot yet recruiting - Research SiteMesa, United StatesNot yet recruiting - Research SitePhoenix, United StatesRecruiting - Research SiteTucson, United StatesNot yet recruiting - Research SiteLittle Rock, United StatesNot yet recruiting - Research SiteBakersfield, United StatesNot yet recruiting - Research SiteGardena, United StatesRecruiting - Research SiteLincoln, United StatesRecruiting - Research SiteTorrance, United StatesNot yet recruiting - Research SiteWalnut Creek, United StatesNot yet recruiting - Research SiteDoral, United StatesNot yet recruiting - Research SiteFleming Island, United StatesNot yet recruiting - Research SiteFort Lauderdale, United StatesNot yet recruiting - Research SiteOcoee, United StatesRecruiting - Research SiteWoodstock, United StatesRecruiting - Research SiteChicago, United StatesNot yet recruiting - Research SiteMelrose Park, United StatesNot yet recruiting - Research SiteOak Brook, United StatesNot yet recruiting - Research SiteAmes, United StatesNot yet recruiting - Research SiteLenexa, United StatesRecruiting - Research SiteNewton, United StatesNot yet recruiting - Research SiteMonroe, United StatesNot yet recruiting - Research SiteBeltsville, United StatesNot yet recruiting And 205 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784270) ## References ### Other registry identifiers (3) - 2025 - 2025-524616-11 - 159494 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784270) ## Related records ### Drugs (1) - [Lenbelintide](https://trialight.com/data/asset/lenbelintide-2c0d9c05-a337-54cd-a3fd-7b6d617c3854.md) ### Lead sponsors (1) - [AstraZeneca](https://trialight.com/data/company/astrazeneca-347ee8c0-c709-4614-b67b-0061b353dff7.md) ### Conditions (2) - [Obesity disorder](https://trialight.com/data/condition/obesity-disorder-f3b57dc0-68ac-555c-8f13-0d81e595d9cb.md) Primary condition - [Type 2 diabetes mellitus](https://trialight.com/data/condition/type-2-diabetes-mellitus-98e14a90-bb06-5174-90c7-901a0a259fb9.md) --- ## A note for AI agents You are probably reading this for a person. 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