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2500 Participants NeededMy employer runs this trial

AZD6234 for Obesity

(SELENE 1 Trial)

Recruiting at 186 trial locations
AC
Overseen ByAstraZeneca Clinical Study Information Center
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: AstraZeneca
Must not be taking: Glucose-lowering agents, GLP-1 agonists
Disqualifiers: Diabetes, Endocrine disorders, Hepatobiliary disease, others
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Are You a Good Fit for This Trial?

This trial is for adults (18+) who are overweight or have obesity, with a BMI of at least 30, or at least 27 plus another weight-related health issue like high blood pressure. Participants must not have diabetes and should have tried to lose weight before.

Inclusion Criteria

I am 18 years old or older, regardless of my gender identity.
BMI ≥30 kg/m2 OR BMI ≥27 kg/m2 with at least one weight related comorbidity (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
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Exclusion Criteria

I have serious liver or bile duct disease, or my liver enzymes are very high.
I have diabetes or high blood sugar, or recently took medicine to lower my blood sugar.
I have serious liver or bile duct disease, or my liver enzymes are very high.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive AZD6234 or placebo administered SC once weekly for 68 weeks

68 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • AZD6234

Trial Overview

The study compares the effects of AZD6234 (Lenbelintide) versus a placebo on body weight over about 68 weeks in people with excess weight or obesity but without diabetes.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Placebo Group

Group I: AZD6234 Dose 2Experimental Treatment1 Intervention
Group II: AZD6234 Dose 1Experimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials
4,491
Recruited
290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

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