> 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-4a20abc8-f6a4-443a-9e15-a1e0e92091bf > Record changed: 2026-11-04 # A Study to Evaluate Effect of AZD6234 in Adult Participants With Obesity or Overweight With Weight-related Comorbidity Without Type 2 Diabetes Mellitus NCT07784725 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784725) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784725) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784725) Participants 2,500 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784725) Lead sponsor AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784725) Start date 2026-08-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784725) Number of sites 220 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784725) ## 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/NCT07784725) **Acronym** SELENE 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784725) **Short title** A Study to Evaluate Effect of AZD6234 in Adult Participants With Obesity or Overweight With Weight-related Comorbidity Without Type 2 Diabetes Mellitus Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784725) **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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784725) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784725) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784725) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784725) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784725) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784725) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784725) ## Dates **Completion date** 2029-05-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784725) **First posted** 2026-08-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784725) **Registry last updated** 2026-10-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784725) **Primary completion date** 2028-08-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784725) **Start date** 2026-08-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784725) ## Size and sites **Participants** 2,500 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784725) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784725) **Planned participants** 2,500 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784725) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784725) **Number of sites** 220 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784725) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784725) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784725) **Lead sponsor** AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784725) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784725) ## Identifiers **Registry ID** NCT07784725 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784725) **ClinicalTrials.gov ID** NCT07784725 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784725) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784725) ## 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/NCT07784725) ## 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 as 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 as 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 as 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 as compared to placebo in body weight loss of at least 10% 4. Change in waist circumference (cm) from baseline at 68 weeks of treatment Timeframe: 68 weeks To evaluate the effect of AZD6234 as compared to placebo on waist circumference change 5. Percent change in triglycerides from baseline at 68 weeks of treatment Timeframe: 68 weeks To evaluate the effect of AZD6234 as compared to placebo on triglycerides percent change 6. Change in systolic blood pressure (mmHg) from baseline at 68 weeks of treatment Timeframe: 68 weeks To evaluate the effect of AZD6234 as compared to placebo on systolic blood pressure change 7. 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 as compared to placebo on body composition change in the DXA subset of participants Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784725) ## 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 ≥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 ### Exclusion criteria - 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784725) ## Sites - Research SiteDothan, United StatesRecruiting - Research SiteHuntsville, United StatesNot yet recruiting - Research SiteMesa, United StatesNot yet recruiting - Research SiteEscondido, United StatesRecruiting - Research SiteBridgeport, United StatesNot yet recruiting - Research SiteClearwater, United StatesRecruiting - Research SiteJacksonville, United StatesNot yet recruiting - Research SiteStockbridge, United StatesRecruiting - Research SiteChampaign, United StatesRecruiting - Research SiteChicago, United StatesRecruiting - Research SiteAmes, United StatesRecruiting - Research SiteEl Dorado, United StatesNot yet recruiting - Research SiteOwensboro, United StatesNot yet recruiting - Research SiteTroy, United StatesNot yet recruiting - Research SiteJefferson City, United StatesNot yet recruiting - Research SiteKansas City, United StatesRecruiting - Research SiteButte, United StatesNot yet recruiting - Research SiteLas Vegas, United StatesNot yet recruiting - Research SiteJersey City, United StatesNot yet recruiting - Research SiteCortland, United StatesNot yet recruiting - Research SiteRochester, United StatesNot yet recruiting - Research SiteRocky Mount, United StatesRecruiting - Research SiteStatesville, United StatesRecruiting - Research SiteWilmington, United StatesNot yet recruiting - Research SiteFargo, United StatesRecruiting And 195 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784725) ## References ### Other registry identifiers (3) - 2025 - 2025-523379-41-00 - 159494 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07784725) ## 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 (1) - [Obesity disorder](https://trialight.com/data/condition/obesity-disorder-f3b57dc0-68ac-555c-8f13-0d81e595d9cb.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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