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1500 Participants NeededMy employer runs this trial

AZD6234 for Obesity

(SELENE 2 Trial)

Recruiting at 183 trial locations
AC
Overseen ByAstraZeneca Clinical Study Information Center
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: AstraZeneca
Must be taking: Oral glycaemic-lowering agents
Must not be taking: GLP-1 medications, Insulin
Disqualifiers: Type 1 diabetes, 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+) with type 2 diabetes and a BMI of at least 27, who are overweight or obese. They must have stable weight for the past 3 months, be managing diabetes without recent insulin or GLP-1 drugs, and have tried unsuccessfully to lose weight before.

Inclusion Criteria

I have had type 2 diabetes for at least 90 days.
My HbA1c is between 6.0% and 10%, managed by diet, exercise, or stable oral medication.
Stable body weight (≤5% body weight change) for at least 3 months prior to Randomisation
See 3 more

Exclusion Criteria

I have used a GLP-1 medication in the past 3 months.
I have used insulin for type 2 diabetes in the past 3 months.
I have Type 1 diabetes or recently had serious diabetic complications.
See 4 more

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 for 68 weeks to evaluate efficacy and safety in terms of body weight change

68 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • AZD6234

Trial Overview

The study compares AZD6234 to a placebo in people with type 2 diabetes and excess weight. Participants will receive either AZD6234 or an inactive treatment by chance, and changes in body weight over about 68 weeks will be measured.

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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