AstraZeneca is advancing two investigational obesity treatments through Phase IIb clinical trials, marking significant progress in the pharmaceutical giant's efforts to address the growing global obesity epidemic. The company is simultaneously evaluating AZD5004, an oral therapy, and AZD6234, an injectable treatment, both targeting adults with obesity or overweight conditions accompanied by weight-related comorbidities.
AZD5004 Oral Treatment Study
The AZD5004 trial represents a comprehensive Phase IIb, global, randomized, parallel-group, double-blind, placebo-controlled, multicenter study designed to assess both efficacy and safety. The study will evaluate five different doses of AZD5004 compared with placebo, administered once daily as oral tablets for 36 weeks.
Approximately 304 participants will be randomized in this study, targeting adults aged 18 years and above who are living with obesity (BMI ≥30 kg/m²) or are overweight (BMI ≥27 kg/m²) with at least one weight-related comorbidity. The qualifying comorbidities include hypertension, dyslipidemia or hyperlipidemia, cardiovascular disease, and obstructive sleep apnea.
The study features dual primary endpoints that will measure treatment effectiveness at 26 weeks: the percent change in body weight from baseline and the proportion of participants achieving weight loss of at least 5% of baseline weight.
AZD6234 Injectable Treatment Study
The second Phase IIb trial focuses on AZD6234, administered as a once-weekly subcutaneous injection over 36 weeks. This randomized, double-blind, placebo-controlled study will evaluate the efficacy, safety, and tolerability of the investigational treatment compared with placebo.
The AZD6234 study will enroll approximately 231 eligible participants across four cohorts, targeting the same patient population as the AZD5004 trial: adults with obesity (BMI ≥30 kg/m²) or overweight individuals (BMI ≥27 kg/m²) with at least one weight-related comorbidity.
Study Design and Timeline
Both trials follow similar structural frameworks, each comprising a screening period of maximum 28 days, followed by the 36-week treatment period, and concluding with a follow-up period after the last dose of study drug. This comprehensive approach allows for thorough safety monitoring and efficacy assessment throughout the treatment duration and beyond.
The parallel development of both oral and injectable formulations demonstrates AstraZeneca's commitment to providing diverse treatment options for patients with varying preferences and clinical needs. The oral route offers convenience for daily administration, while the weekly injectable format may provide sustained therapeutic effects and potentially improved adherence for some patients.
Clinical Significance
These Phase IIb trials represent critical steps in the development of new therapeutic options for obesity management. The focus on participants with weight-related comorbidities addresses a significant clinical need, as these patients often face increased health risks and may require more intensive interventions beyond lifestyle modifications alone.
The 36-week treatment duration in both studies provides sufficient time to evaluate meaningful weight loss outcomes and assess the sustainability of therapeutic effects. The inclusion of safety and tolerability assessments alongside efficacy measures ensures comprehensive evaluation of both treatments' clinical profiles.
