The Most Buzzworthy Type 2 Diabetes Drug in Development? Tirzepatide

By Jeemin Kwon

The study aims to enroll about 1,800 adults with type 2 diabetes at increased risk of heart disease

Clinical Trials Identifier: NCT03730662

Trial name: A Study of Tirzepatide (LY3298176) Once a Week Versus Insulin Glargine Once a Day in Participants With Type 2 Diabetes and Increased Cardiovascular Risk (SURPASS-4)

Diabetes type: Type 2

What the trial is testing: the efficacy and safety of tirzepatide, a new therapy in development by Lilly, in people with type 2 diabetes and increased heart disease risk. Participants will either receive tirzepatide once a week or Lantus once a day.

What the trial is measuring: Change in A1C is the primary outcome, and researchers are also examining change in body weight, self-monitored blood glucose values, and frequency of hypoglycemia (low blood sugar).

Why is this new/important? Tirzepatide belongs to a new class of drugs called dual GIP and GLP-1 receptor agonists. At EASD 2018, we learned of exciting phase 2 trial results that showed compared to Trulicity (once-weekly injectable GLP-1 agonist), participants taking the highest dose of tirzepatide had greater weight loss (25 lbs vs. 6 lbs) and greater A1C reduction (1.9% vs. 1.2%). An impressive 90% of tirzepatide users had an A1C below 7% by the end of the trial. A downside was the side effects – nausea, diarrhea, and vomiting. This larger phase 3 trial aims to show safety and efficacy data to support FDA approval. While this trial is not specifically looking at heart health outcomes, it’s likely that researchers are seeking to understand the safety of use in people with increased risk.

Trial length: Up to two years

Trial locations: The trial is enrolling across 168 locations, including several US states such as California, Florida, Massachusetts, and Texas. See a full list here.

Do you qualify? Select inclusion criteria include:

• A1C between 7.5% and 10.5%
• Be on at least one but no more than three of the following diabetes therapies: metformin, SGLT-2 inhibitors (Farxiga, Invokana, Jardiance, etc.), sulfonylureas (glipizide, gliclazide, etc.)
• Increased risk for cardiovascular (CV) events (heart attack, stroke), but have not had a CV event in the past two months; risk factors include high blood pressure, high cholesterol, diabetes, and smoking
• Body mass index (BMI) greater than 25 kg/m² (see BMI calculator here)
• See a full list of eligibility criteria here

Where to get more information: Contact Lilly at 1-877-285-4559 or clinicaltrials.gov@lilly.com