A Study to Evaluate Effect of AZD6234 in Adult Participants With Obesity or Overweight With Weight-related Comorbidity Without Type 2 Diabetes Mellitus
- 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
- Acronym
- SELENE 1
- 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
- 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)
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2029-05-21
- First posted
- 2026-08-25
- Registry last updated
- 2026-10-30
- Primary completion date
- 2028-08-11
- Start date
- 2026-08-19
- Participants
- 2,500
- Participant count basis
- Estimated
- Planned participants
- 2,500
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- AstraZeneca
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07784725
- ClinicalTrials.gov ID
- NCT07784725
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
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
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
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%
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%
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
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
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
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
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
- 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
-
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.
- 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.
- 2025
- 2025-523379-41-00
- 159494
Related records
Drugs (1)
Lead sponsors (1)
Conditions (1)
- Obesity disorder Primary condition