Evaluation of Safety, Tolerability, and Pharmacokinetics of ALY688ER in Overweight or Obese Adults with Nonalcoholic Steatohepatitis (NASH)

The primary objective of this clinical trial is to evaluate the safety, tolerability, and pharmacokinetics of ALY688ER administered via subcutaneous injection in healthy overweight or obese individuals. Assessment of these parameters is essential to determine the systemic interaction and physiological impact of the investigational product prior to broader clinical application. The scope of this study includes 4: Safety, 6: Pharmacokinetic.

The sponsor did not provide information regarding the total number of participants. The study population consists of healthy volunteers, including both males and females, who are categorized as a vulnerable population. The participants fall within the age range corresponding to codes 3 and 4. The investigation involves individuals with non-alcoholic steatohepatitis.

This Phase 1 clinical trial is designed to evaluate the safety, tolerability, and pharmacodynamics of ALY688ER, which is administered via subcutaneous injection. The study will involve healthy overweight or obese individuals. The research methodology utilizes a controlled design to assess the body's interaction with the investigational product. The clinical sequence begins with a screening visit to determine eligibility. Subsequent follow-up visits are scheduled to monitor physiological responses and safety parameters. The process concludes with an end-of-study visit. Total participant involvement is expected to occur within the recruitment period spanning from March 2026 to December 2026. Participation may be subject to early termination based on specific clinical criteria or safety protocols.

The assessment of efficacy in this study is focused on the management of non-alcoholic steatohepatitis. No specific parameters, measurement methods, or assessment tools have been defined for the evaluation of treatment effect.