AZD6234 + AZD9550 for Obesity
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the effects of two drugs, AZD6234 and AZD9550, on the function of a common birth control pill in women with obesity. Researchers aim to determine how these drugs might alter the body's processing of the birth control pill and assess the drugs' safety. Women with a body mass index (BMI) of 25 or higher who are not pregnant or breastfeeding may qualify for the trial. Participants must also use non-hormonal birth control methods during the study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
If you are using hormonal contraceptives or estrogen-containing birth control, you will need to stop taking them for this trial. The protocol does not specify other medications, so it's best to discuss your current medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that AZD6234 has been tested for safety in people with obesity. In these studies, most participants tolerated the treatment well, experiencing no serious side effects. Common mild side effects included nausea and headaches.
Other studies have examined the safety of using AZD6234 with AZD9550. This combination was also generally well-tolerated, with no major safety issues identified. However, some participants experienced mild side effects such as stomach discomfort.
Since this trial is in an early stage, it primarily focuses on assessing the treatment's safety in humans. While some evidence of safety exists, researchers continue to gather more detailed information. Prospective participants should consider these insights and discuss any concerns with their healthcare provider.12345Why are researchers excited about this trial's treatments?
Researchers are excited about AZD6234 and AZD9550 because they offer a novel approach to tackling obesity. Unlike current treatments that often focus on appetite suppression or fat absorption, these drugs are designed to work together potentially targeting metabolic pathways to enhance weight loss. AZD6234 is administered subcutaneously, which could offer a more consistent absorption compared to oral medications. Moreover, combining AZD6234 with AZD9550 might provide a synergistic effect, making this combination a promising new option for those struggling with weight management.
What evidence suggests that this trial's treatments could be effective for obesity?
Studies have shown that AZD6234 can help people lose weight. Participants taking this medication lost over 10% of their body weight after 26 weeks, significantly more than those who did not take it. In this trial, some participants will receive AZD6234 alone, while others will receive a combination of AZD6234 and AZD9550. Research on the combination of AZD6234 and AZD9550 appears promising, and this combination is being tested to determine if it can enhance weight loss further. Both treatments aim to help individuals with obesity manage their weight more effectively.13467
Are You a Good Fit for This Trial?
Healthy female participants with obesity (BMI ≥ 25 kg/m2 and weight at least 60 kg), not lactating, using non-hormonal contraception if sexually active. Excludes current smokers, those with severe allergies or important medical conditions, recent statin users, or anyone on estrogen-containing products.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Start
Initial administration of study drugs and baseline assessments
Up-titration
Gradual increase in dosage of AZD6234 and AZD9550
Maintenance
Participants receive stable doses of AZD6234 and AZD9550
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- AZD6234
- AZD9550
Trial Overview
The trial is testing the effects of AZD6234 alone and in combination with AZD9550 on how the body processes a common oral contraceptive (EE/LEVO) in women living with overweight or obesity.
How Is the Trial Designed?
All participants will receive combined oral contraceptive EE/LEVO and separately, APAP, treatments throughout the study during the up-titration and maintenance periods of subcutaneous administered AZD6234 and AZD9550.
Participants will receive combined oral contraceptive (EE/LEVO) and, separately, APAP, treatments throughout the study during the up-titration and maintenance periods of subcutaneous AZD6234 administration.
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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
Study Details | NCT06851858 | Efficacy, Safety and ...
The study is being conducted across sites in the USA to evaluate the efficacy, safety, and tolerability of AZD6234 in adults with overweight or obesity and type ...
A weight loss study evaluating subcutaneous treatment ...
The purpose of this study is to determine whether treatment with AZD9550 when given in combination with AZD6234 as once weekly subcutaneous (SC) injections ...
Efficacy, Safety and Tolerability of AZD6234 in Participants ...
Weight loss ≥ 10% from baseline at Study Week 26 (From baseline to week 26) · Absolute change in body weight (kg) from baseline at Study Week 26 ...
4.
astrazeneca.com
astrazeneca.com/content/dam/az/Investor_Relations/events/Weight-Management-Virtual-Event-IR-presentation.pdfWeight Management Virtual Event
Presented at Obesity Week 2024. Phase I SAD demonstrated efficacy with promising tolerability. AZD6234 | LA amylin. Body weight change after ...
5.
finance.yahoo.com
finance.yahoo.com/news/astrazenecas-obesity-pills-revealed-positive-163641942.htmlAstraZeneca's Obesity Pills Revealed Positive Result In ...
Efficacy: AZD6234 showed a statistically significant reduction in body weight compared to placebo. Market Position: AZD6234 is positioned ...
A study to assess the safety, tolerability, pharmacokinetics ...
A study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of AZD6234 after repeat dose administration in participants who are ...
AZD6234 for Obesity · Info for Participants
For specific safety data on AZD6234, further investigation into clinical trial results or specific studies on this drug would be necessary. Show more.
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