WRITTEN BY: MAKAILA HEIFNER
Editor’s Note: This article was updated on 2/17/21 and adds to our ongoing coverage of Tirzepatide, a potential new treatment for people with Type 2 diabetes that is currently in development in clinical trials.
Lilly Diabetes reported that in the 52-week SURPASS-3 phase three clinical trials, the longest in the programs to date, that the highest dose of tirzepatide (15 mg) led to significant A1C and bodyweight reduction in adults with Type 2 diabetes. A1C by 2.37 percent and body weight by 12.9 kg/28.4 lbs (13.9 percent).
SURPASS-3 isn’t the only clinical trial that’s shown positive results. The other clinical trial, SURPASS-5, a 40-week study, also showed the highest dose of tirzepatide (15 mg) reduced A1C 2.59 percent and body weight by 10.9 kg/24 lbs. In SURPASS-5, participants who received the highest dose and on average, have had diabetes for a little over 13 years, achieved an A1C of less than 5.7 percent — the level seen in people without diabetes.
In both studies, the overall safety profile is similar to that of a glucagon-like peptide (GLP-1 1) receptor agonist, with gastrointestinal side effects being the most commonly reported.
Mike Mason, president of Lilly Diabetes, provided remarks on the latest findings and acknowledged the importance of tirzepatide’s impact on managing Type 2 diabetes. “Tirzepatide delivered impressive A1C and body weight reductions in both studies and continued to achieve consistent efficacy and safety results in people living with type 2 diabetes, regardless of how long they have had the condition,” said Mason. “Significantly lowering A1C levels and weight is high priorities throughout the type 2 diabetes treatment journey, and the results we have seen from three SURPASS studies to date fuel our belief in tirzepatide’s ability to meet those needs.”
Tirzepatide “is a once-weekly dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist that integrates the actions of both incretins into a single novel molecule.” In other words, tirzepatide works by decreasing food intake and increasing energy output which works in tandem to generate weight loss and regulate blood glucose levels. This also marks the first-ever dual GIP-GLP combo drug used for Type 2 treatment.
These new findings are similar to the results published in January when Lilly Diabetes reported tirzepatide significantly reduced A1C and body weight in adults with Type 2 diabetes. Participants who used the highest dose of tirzepatide reduced A1Cs by 2.07% and body weight by 11%; about 50% of patients in this study achieved an A1C of less than 5.7%.
The study observed that each of the tirzepatide doses led to lower A1Cs and reducded body weight. Lilly reported the following:
- A1C reduction: -1.75% (5 mg), -1.71% (10 mg), -1.69% (15 mg), -0.09% (placebo)
- Weight reduction: -6.3 kg (5 mg), -7.0 kg (10 mg), -7.8 kg (15 mg), -1.0 kg (placebo)
- Percentage of participants achieving A1C <7%: 81.8% (5 mg), 84.5% (10 mg), 78.3% (15 mg), 23.0% (placebo)
- Percentage of participants achieving A1C <5.7%: 30.9% (5 mg), 26.8% (10 mg), 38.4% (15 mg), 1.4% (placebo)”
During this study, no extreme lows (54 mg/dL or below) occurred. However, some side effects have been reported while using tirzepatide, such as nausea, diarrhea, vomiting, and constipation.
Currently, tirzepatide is in phase 3 development for blood glucose management in adults with Type 2 diabetes. Phase 3 included 478 random study participants from the United States, Mexico, India, and Japan; patients were either given 5 mg, 10 mg, or 15mg of tirzepatide or a placebo (no treatment) in a 1:1:1:1 ratio during a 40-week period. This was done in order to demonstrate that using tirzepatide, especially higher doses of the medication, resulted in a greater outcome for A1C and body weight reductions opposed to no treatment.
“We are impressed by these initial results showing how tirzepatide performed in people with a relatively short duration of diabetes,” said Manson in January. “We look forward to seeing more results in people who are later in the course of diabetes in future studies from our robust SURPASS clinical trial program.”
Further data about the SURPASS clinical trial will be presented at the American Diabetes Association Scientific Sessions later this year.