Posted on February 21, 2025 - 12:26 am by Ali Chappell

Introducing the LILACS Study: Advancing PCOS Treatment Through Science

Are you a patient with PCOS or a healthcare provider looking for an innovative, non-medication approach to managing PCOS symptoms? If so, we invite you to learn more about the LILACS Study—a clinical trial evaluating the effectiveness of the Lilli App, a lifestyle-based digital tool designed to address insulin resistance, the root cause of many PCOS symptoms.

This study is an important step in supporting FDA clearance of the Lilli App as a treatment for insulin resistance in patients with PCOS, making it the first digital tool of its kind to receive regulatory approval.

Why Is This Study Important?

Polycystic Ovary Syndrome (PCOS) is one of the most common endocrine disorders affecting women of reproductive age, yet treatment options remain limited. While many providers rely on medications like birth control or metformin to manage symptoms, these approaches do not address the underlying cause—insulin resistance.

Research has shown that elevated insulin levels drive many of the hallmark symptoms of PCOS, including irregular periods, infertility, weight gain, acne, and excessive hair growth. Yet, most PCOS patients never have their insulin levels tested, and current treatment guidelines do not prioritize insulin management.

At Lilli Health, we believe this needs to change. The LILACS Study aims to provide scientific evidence that an app-based Low Insulin Lifestyle program can effectively lower insulin levels, improve PCOS symptoms, and offer a validated, FDA-cleared treatment option for patients struggling with this condition.

What Is the LILACS Study?

The LILACS Study is an 8-week, randomized, waitlist-controlled study evaluating the impact of the Lilli App on PCOS management.

Participants will be randomly assigned to either begin the program immediately or be placed on a waitlist for 8 weeks before starting. This allows researchers to compare differences between those actively using the app and those who are not, helping to determine the app’s effectiveness.

What Will the Study Measure?

The LILACS Study will assess how using the Lilli App impacts key markers of insulin resistance and PCOS symptoms, including:

Fasting insulin levels – to determine if insulin levels improve with the Low Insulin Lifestyle approach
Weight changes – to assess improvements in metabolic health
Menstrual cycle regularity – to evaluate if insulin management leads to more predictable ovulation and periods
PCOS-related symptoms – including acne, excess hair growth, fatigue, mood, and cravings
Quality of life – measuring how changes in insulin levels impact energy, mood, and overall well-being

This study is a critical step toward securing FDA clearance for the Lilli App as a science-backed treatment for PCOS, making it more widely accessible to those who need it.

Who Can Participate?

We are looking for women who have been diagnosed with PCOS and are ready to take an active role in managing their health. Participants must meet the following criteria:

✅ Women aged 18-45
✅ Have a formal diagnosis of PCOS
✅ Are not currently pregnant or breastfeeding
✅ Are motivated to try a non-medication, lifestyle-based approach

How to Join the LILACS Study

If you or someone you know has PCOS and is interested in participating, the process is simple:

1️⃣ Visit Lilacs-Study.com
2️⃣ Complete a short interest form
3️⃣ If eligible, our team will follow up with next steps on how to enroll

When is the LILACS Study Going to Start?

We are on track to launch the study in April/May of 2025!

Why Your Participation Matters

PCOS treatment has remained unchanged for decades, with many patients being told that birth control and metformin are their only options. By joining the LILACS Study, you are not only taking a step toward improving your own health—you are also helping to advance research that could change the standard of care for PCOS and make insulin testing and management a key part of future treatment guidelines.

Your referral could help provide a new, innovative treatment option for patients who have been told for too long that there are no other solutions.