Evaluation of AZD5462 Combined with Dapagliflozin in Heart Failure Patients with Moderate Renal Impairment: A Phase Ib Randomized, Placebo-Controlled, Double-Blind, Multicenter Study

The primary objective of this study is to evaluate the **safety** and effects of AZD5462 when administered in conjunction with Dapagliflozin in participants diagnosed with **heart failure** and **moderate renal impairment**. This investigation is clinically relevant as it aims to determine the potential benefits and risks of combining these treatments, which could inform therapeutic strategies for managing heart failure in patients with concurrent renal impairment.

The clinical trial involves participants diagnosed with **moderate renal impairment** and **heart failure**. The study population includes both male and female subjects, with an age range corresponding to categories 3 and 4, which typically represent adults and older adults. The trial does not specifically target a vulnerable population. The sponsor has not provided information regarding the total number of participants or specific lifestyle considerations such as diet, physical activity, or habits. The selection criteria for the trial population have not been disclosed, and no principal inclusion criteria have been specified. The sponsor has not given further details on the general health status of the participants.

The clinical trial is a **Phase Ib**, randomized, placebo-controlled, double-blind, multicenter study designed to evaluate the effects and safety of AZD5462 in combination with dapagliflozin in participants with **heart failure** and **moderate renal impairment**. The trial is expected to commence recruitment on September 23, 2024, and conclude by November 4, 2024. Participants will be randomly assigned to receive either the investigational drug or a placebo, ensuring that neither the participants nor the investigators are aware of the treatment allocation, thus maintaining the double-blind nature of the study.

The trial will involve several study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. Following successful screening, participants will undergo baseline assessments before randomization. Throughout the study, participants will attend regular follow-up visits to monitor safety, efficacy, and any adverse events. These visits will include clinical evaluations, laboratory tests, and other relevant assessments as per the study protocol. The end-of-study visit will mark the conclusion of the participant's involvement, where final evaluations will be conducted to gather comprehensive data on the treatment's impact.

The expected duration of participant involvement will align with the overall trial timeline, from the initial screening to the end-of-study visit. Conditions that may lead to early termination from the study include significant adverse events, withdrawal of consent, or any other protocol-defined criteria that compromise participant safety or data integrity. The study is structured to ensure rigorous adherence to ethical standards and scientific validity, contributing valuable insights into the management of heart failure and moderate renal impairment.

The clinical trial involves the administration of an **experimental medication**. However, specific details regarding the name, pharmaceutical form, dosage, route, and frequency of administration of the experimental medication are not provided in the available data. The trial documentation does not specify whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. Additionally, there is no information on the maximum daily dose, total dose, or treatment period for the experimental medication.

In addition to the experimental medication, the trial may include the use of **non-experimental treatments** such as standard-of-care therapy, placebo, or comparator treatments. However, the data does not provide explicit details about these treatments. Information regarding the administration, dosing schedules, and participant compliance monitoring for these non-experimental treatments is also not available.

The clinical trial is in Phase 3 and is scheduled to have an estimated recruitment start date of September 23, 2024, with an estimated end date of November 4, 2024. The efficacy of the intervention will be assessed through a structured evaluation process. Although specific primary and secondary endpoints are not detailed, typical Phase 3 trials often focus on assessing the effectiveness of a treatment in a larger patient population to confirm its efficacy, monitor side effects, and compare it to commonly used treatments. The trial will likely involve systematic data collection and analysis at predetermined timepoints throughout the study duration. The methods for measuring and analyzing efficacy parameters are expected to adhere to rigorous scientific standards, utilizing validated scales, laboratory tests, or patient-reported outcomes as appropriate for the condition under investigation. The trial's design will ensure that efficacy assessments are conducted objectively and consistently across all participants.