SELENE 1

RecruitingPhase 3

A Study to Evaluate Effect of AZD6234 in Adult Participants With Obesity or Overweight With Weight-related Comorbidity Without Type 2 Diabetes Mellitus

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)

Lead sponsor

AstraZeneca

Asset

AZD6234

Subcutaneous · Amylin analog

Listed sites

220

Recruiting sites

Estimated enrollment

2,500

Study population

Obesity / overweight

Eligibility highlights

•BMI ≥30

Primary endpoint

•Body weight

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07784725

Org study IDD8750C00014

Secondary ID159494IND Number

Secondary ID2025

Secondary ID2025-523379-41-00

Timeline

Milestones

Study start2026-08-19actual

Study first posted2026-08-25actual

Last update posted2026-10-30actual

Primary completion2028-08-11estimated

Study completion2029-05-21estimated

Assets

Investigational agents

AZD6234

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition

Cardiometabolic biomarkers

Weight & body composition

6 endpoints

Primary/protocol endpoint

Percent change in body weight from baseline at 68 weeks of treatment

Time frame:68 weeks

percent change from baseline, improvement

Secondary/protocol endpoint

Absolute change in weight (kg) from baseline at 68 weeks of treatment

Time frame:68 weeks

change from baseline, improvement

Secondary/protocol endpoint

Achievement of at least 5 % body weight loss from baseline at 68 weeks of treatment

Time frame:68 weeks

threshold achievement, improvement

Secondary/protocol endpoint

Achievement of at least 10% body weight loss from baseline at 68 weeks of treatment

Time frame:68 weeks

threshold achievement, improvement

Secondary/protocol endpoint

Change in waist circumference (cm) from baseline at 68 weeks of treatment

Time frame:68 weeks

change from baseline, improvement

Secondary/protocol endpoint

Percent change in fat mass from baseline at 68 weeks of treatment measured by DXA in the DXA Sub-Study subset

Time frame:68 weeks

percent change from baseline, improvement

Cardiometabolic biomarkers

2 endpoints

Secondary/protocol endpoint

Percent change in triglycerides from baseline at 68 weeks of treatment

Time frame:68 weeks

percent change from baseline, improvement

Secondary/protocol endpoint

Change in systolic blood pressure (mmHg) from baseline at 68 weeks of treatment

Time frame:68 weeks

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.