500 Participants NeededMy employer runs this trial

AZD6234 for Obesity

(SELENE 3 Trial)

Recruiting at 80 trial locations
AC
Overseen ByAstraZeneca Clinical Study Information Center
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: AstraZeneca
Must be taking: Incretin-based medications
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?

This trial evaluates how well a new treatment, AZD6234 (an experimental drug), aids in safe weight loss for individuals with excess weight or obesity. Participants will receive either AZD6234 or a placebo (a pill with no active medication) to assess changes in body weight over 68 weeks. This trial suits adults who have struggled to lose weight, have a BMI of 30 or more, or a BMI of 27 with conditions like high blood pressure or sleep apnea. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking weight loss treatment.

Is there any evidence suggesting that AZD6234 is likely to be safe for humans?

Research shows that AZD6234 has been tested for safety in individuals who are overweight or have obesity. In earlier studies, most participants tolerated the treatment well. However, like many obesity drugs, concerns about the liver, gallbladder, and pancreas can arise. These side effects are closely monitored during the trials.

Since this trial is in a later stage, AZD6234 has already demonstrated some safety in earlier tests. While side effects might occur, they are not expected to be serious for most participants. Researchers will carefully monitor any negative effects to ensure the treatment remains safe.12345

Why do researchers think this study treatment might be promising for obesity?

Unlike the standard treatments for obesity, which often include lifestyle changes, medications like orlistat, and sometimes surgical procedures, AZD6234 is unique because it targets obesity with a novel mechanism. While many current medications focus on reducing appetite or blocking fat absorption, AZD6234 works by a different pathway, potentially offering a new way to tackle weight loss. Researchers are excited about this treatment because it could provide an alternative for those who haven't seen success with existing options, and it might offer benefits with fewer side effects. This new approach could revolutionize how we manage obesity and improve outcomes for many individuals.

What evidence suggests that AZD6234 might be an effective treatment for obesity?

This trial will compare AZD6234 with a placebo to evaluate its effectiveness in treating obesity. Studies have shown that AZD6234 can help people with obesity lose a significant amount of weight. In one study, participants taking the highest dose of AZD6234 lost an average of 27.3 pounds (12.4%) over 72 weeks, while those taking a placebo lost only 2.2 pounds (0.9%). Early results also suggest that AZD6234 specifically reduces body fat, targeting fat without affecting lean muscle. Another study found a possible 42.2% reduction in body fat with AZD6234, indicating it could be very effective in lowering body fat. These findings highlight the strong potential of AZD6234 in aiding weight loss.678910

Are You a Good Fit for This Trial?

This trial is for adults who are overweight or have obesity, with at least one weight-related health problem. People can join whether or not they have type 2 diabetes.

Inclusion Criteria

BMI ≥ 30 kg/m2 OR BMI ≥ 27 kg/m2 with at least one weight-related comorbidity (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)
I am 18 years old or older.
History of at least one self-reported unsuccessful attempt to lose body weight in their lifetime
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Exclusion Criteria

ALT ≥ 3.0 × ULN at Screening
AST ≥ 3.0 × ULN at Screening
TBL > 1.5 × ULN at Screening (except known Gilbert's Syndrome)
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 as an adjunct to incretin-based therapies for obesity or overweight with weight-related comorbidity

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 tests AZD6234, a new medication, alongside current incretin-based therapies to see if it helps people lose more weight compared to a placebo over about 68 weeks.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: AZD6234Experimental Treatment1 Intervention
Group II: 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

Citations

A Study to Evaluate Effect of AZD6234 in Adult Participants ...

Efficacy of AZD6234 will be compared to placebo in percent body weight change from baseline at 68 weeks of treatment

A Study to Evaluate Effect of AZD6234 in Adult Participants ...

Secondary outcomes · Absolute change in weight (kg) from baseline at 68 weeks of treatment · Achievement of at least 5 % body weight loss from ...

Amylin: From Mode of Action to Future Clinical Potential in ...

Preliminary results indicate that AZD6234 demonstrates promising efficacy for body fat-selective weight loss [ 115 ]. achieved an average weight loss of 13.1% ...

Highlights from ADA 2025: Oral GLP-1s, Amylin ...

Preclinical data from AZD6234 suggested better fat loss with preserved lean mass - delivered up to 42.2% fat loss. The highest combo dose ...

a8748s

encouraging glucose and body weight reduction levels tested compared to placebo. They have been shown to be effective at decreasing haemoglobin ...

Eli Lilly's obesity therapy meets co-primary objectives

According to the company, the trial participants who received tirzepatide 15mg lost up to 15.7% of body weight for the efficacy estimand.

Lots of interesting movement from AstraZeneca ...

The two most interesting trials to me for AZD6234 (in terms of outcomes) are: ▪️ Weight Loss Study Evaluating Subcutaneous Treatment With ...

Evaluating Weight-Loss Drug Efficacy: How to Choose the Right ...

This article reviews major clinical-stage weight-loss pipelines worldwide and provides a stratified matching framework with standardized obesity animal models ...

Positioning Incretin-Based and Next-Generation Obesity ...

− Additional safety outcomes of particular relevance to obesity pharmacotherapy, including pancreatitis, gallbladder and liver disease, psychiatric adverse ...

Type 1 Diabetes Paid Clinical Trials in Alabama - Policy Lab

Efficacy, Safety and Tolerability of AZD6234 in Participants Living With Overweight or Obesity With Type 2 Diabetes Who Are on a Stable Dose of GLP-1 Receptor ...