AZD6234 for Obesity
(SELENE 2 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called AZD6234, a potential drug, to evaluate its effectiveness and safety for weight loss in people with obesity. Researchers compare the treatment to a placebo (a substance with no active medicine) to determine its impact on reducing body weight over 68 weeks. Suitable participants have a body mass index (BMI) of 27 or higher, Type 2 diabetes managed by diet or oral medication, and have previously attempted weight loss without success. As a Phase 3 trial, this treatment represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking weight loss solutions.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that AZD6234 underwent safety testing in earlier studies with adults who are overweight or have obesity. These studies found that patients generally tolerated AZD6234 well. Common side effects included nausea, constipation, diarrhea, and vomiting, occurring more frequently in those taking AZD6234 compared to a placebo. The treatment has progressed to more advanced testing, indicating existing evidence of safety in humans. While side effects can occur, the treatment is deemed safe enough for testing in a larger population.12345
Why do researchers think this study treatment might be promising for obesity?
Researchers are excited about AZD6234 for obesity because it potentially offers a new way to tackle the condition. Unlike many current treatments, which often focus on appetite suppression or reducing fat absorption, AZD6234 may work by targeting specific metabolic pathways to enhance energy expenditure. This unique mechanism could lead to more effective and sustainable weight loss without the reliance on lifestyle changes alone. Additionally, with two different dosing strategies, AZD6234 offers flexibility in treatment that could cater to individual patient needs.
What evidence suggests that AZD6234 might be an effective treatment for obesity?
Research has shown that AZD6234 may aid in weight loss. In one study, participants taking AZD6234 lost an average of 5.8% of their body weight in just four weeks. Another study found that this treatment outperformed a placebo, with many participants losing at least 5% of their starting weight after 36 weeks. These findings suggest that AZD6234 could be a useful option for those dealing with obesity. However, these results are preliminary, and ongoing studies, including this trial with different doses of AZD6234, will offer more information.678910
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive AZD6234 or placebo for 68 weeks to evaluate efficacy and safety in terms of body weight change
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
AZD6234 Dose 2
AZD6234 Dose 1
Matching placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
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 Weight Loss Study Evaluating Subcutaneous Treatment ...
AZD6234 in combination is superior to placebo for weight loss Weight loss ≥ 5% from baseline after 36 weeks of treatment. Matching Score: 96% Dalong Zhu,
2.
ctv.veeva.com
ctv.veeva.com/study/a-study-to-evaluate-effect-of-azd6234-in-adult-participants-with-obesity-or-overweight-with-weight-rA 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
Effects of AZD5004 in adults who are living with obesity ...
The dual primary endpoints are percent change in body weight from baseline at 26 weeks and the proportion of participants with weight loss ≥ 5% of baseline ...
Efficacy and Safety of Anti‐Obesity Medications for Weight ...
AOMs led to further reductions in body weight (BW, WMD: −8.68 kg, 95% CI: −13.25 to −4.11), waist circumference (WC, WMD: −7.16 cm, 95% CI: −10.34 to − ...
Efficacy, Safety and Tolerability of AZD6234 in Participants ...
Self-reported weight change of > 5 % in the 3 months prior to screening. tolerability of AZD6234 compared with placebo, in adults living with ...
AZD6234 | IMP
AZD6234 clinical trials for weight loss in obesity and overweight, including studies of safety, tolerability, and body weight change.
A Study to Evaluate Effect of AZD6234 as an Adjunct to ...
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 ...
Efficacy, Safety and Tolerability of AZD6234 in Participants ...
The study is being conducted across sites in the USA to evaluate the efficacy, safety, and tolerability of AZD6234 in adults with overweight or ...
Efficacy, Safety and Tolerability of AZD6234 in Participants ...
This Phase II study is a randomized, parallel group, double blinded, placebo-controlled, multicenter to evaluate the efficacy, safety, and tolerability of ...
NCT06132841 | A Study to Assess the Safety, Tolerability ...
The safety and tolerability of repeated subcutaneous (SC) doses of AZD6234 compared to placebo will be assessed. From Screening (Day -35 to Day ...
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