J2A-MC-GZGQ: A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once-Daily Oral LY3502970 Compared With Placebo in Adult Participants With Obesity or Overweight and Type 2 Diabetes (ATTAIN-2)

The primary objective of this Phase 3, randomized, double-blind study is to demonstrate that **LY3502970** is superior to placebo in effecting a change from baseline in body weight among adult participants with **obesity** or **overweight** and **Type 2 Diabetes**. This objective is clinically relevant as it addresses the critical need for effective weight management strategies in this population, which is at increased risk for cardiovascular and metabolic complications. No secondary objectives are specified for this study.

The clinical trial involves a total of **1070 participants** who are both male and female, encompassing an age range that includes adults and older adults. The study population consists of individuals who are **overweight**, have **obesity**, or are diagnosed with **Type 2 Diabetes**. Participants were selected based on specific criteria, including a history of at least one self-reported unsuccessful dietary effort to lose body weight and being on stable treatment for Type 2 Diabetes for at least 90 days prior to screening. Additionally, participants may be taking up to three oral anti-hyperglycemic medications. The trial includes a vulnerable population, indicating that special considerations are in place to ensure their safety and well-being throughout the study. The selection process ensures a diverse representation of individuals who meet the inclusion criteria, providing a comprehensive understanding of the effects of the investigational product on the targeted conditions.

The clinical trial is designed as a **randomized**, **double-blind**, and controlled study to evaluate the efficacy and safety of the investigational medicinal product LY3502970, administered orally in **capsule** form, compared to a placebo. The trial targets adult participants with **obesity**, **overweight**, and **type 2 diabetes**. The primary objective is to demonstrate the superiority of LY3502970 over placebo in terms of mean percent change from baseline in body weight over a period of 72 weeks. The trial is expected to commence recruitment on October 2, 2023, and conclude by September 19, 2025.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on criteria such as being overweight or having a history of unsuccessful dietary efforts to lose weight, and having type 2 diabetes with stable treatment for at least 90 days prior to screening. Following successful screening, participants will be randomized to receive either the investigational product or placebo. The study will include regular follow-up visits to monitor safety, adherence, and efficacy outcomes, culminating in an end-of-study visit at week 72.

The expected duration of participant involvement is approximately 72 weeks, encompassing the screening, treatment, and follow-up phases. Conditions that may lead to early termination from the study include non-compliance with the study protocol, adverse events, or withdrawal of consent. The trial is conducted in accordance with regulatory standards to ensure the safety and well-being of participants throughout the study duration.

The clinical trial involves the administration of the experimental medication **LY3502970**, which is provided in the form of a capsule. The active substance in LY3502970 is a chemical compound with the complex name 3-((1S,2S)-1-(5-((S)-2,2-dimethyltetrahydro-2H-pyran-4-yl)-2-((S)-3-(3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl)-2-(4-fluoro-3,5-dimethylphenyl)-4-methyl-4,5,6,7-tetrahydro-2H-pyrazolo[4,3-c]pyridine-5-carbonyl)-1H-indol-1-yl)-2-methylcyclopropyl)-5-oxo-1,2,4-oxadiazol-4-ide hemicalcium. The medication is administered orally once daily. The maximum treatment period is set to 1 day, with no specified maximum daily or total dose amount. The pharmaceutical form is consistent across all experimental products, and the medication is not formulated for pediatric use.

In addition to the experimental medication, a **placebo** is utilized in the study to match LY3502970. The placebo is identified as sodium bicarbonate and is designed to mimic the appearance of the experimental capsule. The placebo serves as a comparator treatment to evaluate the efficacy and safety of LY3502970 in participants with obesity or overweight and type 2 diabetes. The administration route and frequency for the placebo are consistent with those of the experimental medication, ensuring a double-blind study design.

The efficacy of the investigational medicinal product LY3502970 will be assessed in a Phase 3, randomized, double-blind clinical trial. The primary endpoint for evaluating efficacy is the mean percent change from baseline in body weight, measured from baseline to Week 72. This endpoint is designed to demonstrate that LY3502970 is superior to placebo in reducing body weight in adult participants with obesity or overweight and **Type 2 Diabetes**. The trial will involve once-daily oral administration of LY3502970, with efficacy assessments conducted at specified intervals throughout the study duration.