Mounjaro delivered superior A1C reductions versus all comparators in phase 3 SURPASS clinical trials
While not indicated for weight loss, Mounjaro led to statistically-significantly greater weight reductions versus comparators in a key secondary endpoint
Mounjaro represents the first new class of diabetes medicines introduced in nearly a decade and is expected to be available in the US in the coming weeks
The U.S. Food and Drug Administration (FDA) approved Mounjaro™ (tirzepatide) injection, Eli Lilly and Company’s new once-weekly GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Mounjaro has not been studied in patients with a history of pancreatitis and is not indicated for use in patients with type 1 diabetes mellitus.
As the first and only FDA-approved GIP and GLP-1 receptor agonist, Mounjaro is a single molecule that activates the body’s receptors for GIP and GLP-1, which are natural incretin hormones.
“Mounjaro delivered superior and consistent A1C reductions against all comparators throughout the SURPASS program, which was designed to assess Mounjaro’s efficacy and safety in a broad range of adults with type 2 diabetes who could be treated in clinical practice. The approval of Mounjaro is an exciting step forward for people living with type 2 diabetes given the results seen in these clinical trials”, said Dr. Juan Pablo Frías, Medical Director, National Research Institute and Investigator in the SURPASS program.
Mounjaro will be available in 6 doses (2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg) and will come in Lilly’s well-established auto-injector pen with a pre-attached, hidden needle that patients do not need to handle or see.
The approval was based on results from the phase 3 SURPASS program, which included active comparators of injectable semaglutide 1 mg, insulin glargine and insulin degludec. Efficacy was evaluated for Mounjaro 5 mg, 10 mg and 15 mg used alone or in combination with commonly prescribed diabetes medications, including metformin, SGLT2 inhibitors, sulfonylureas and insulin glargine. Participants in the SURPASS program achieved average A1C reductions between 1.8% and 2.1% for Mounjaro 5 mg and between 1.7% and 2.4% for both Mounjaro 10 mg and Mounjaro 15 mg. While not indicated for weight loss, mean change in body weight was a key secondary endpoint in all SURPASS studies. Participants treated with Mounjaro lost between 12 lb. (5 mg) and 25 lb. (15 mg) on average.
…About the SURPASS clinical trial program: The SURPASS phase 3 global clinical development program for tirzepatide began in late 2018 and included 5 global registration trials and 2 regional trials in Japan. These studies ranged 40–52 weeks and evaluated the efficacy and safety of Mounjaro 5 mg, 10 mg and 15 mg as a monotherapy and as an add-on to various standard-of-care medications for type 2 diabetes. The active comparators in the studies were injectable semaglutide 1 mg, insulin glargine and insulin degludec. Collectively, the 5 global registration trials consistently demonstrated A1C reductions for participants taking Mounjaro across multiple stages of their type 2 diabetes journeys, from an average ~5–13 years of having diabetes.
SURPASS-1 (NCT03954834) was a 40-week study comparing the efficacy and safety of Mounjaro 5 mg (n = 121), 10 mg (n = 121) and 15 mg (n = 120) as monotherapy to placebo (n = 113) in adults with type 2 diabetes inadequately controlled with diet and exercise alone.
From a baseline A1C of 7.9%, Mounjaro reduced participants’ A1C by a mean of 1.8% (5 mg) and 1.7% (10 mg and 15 mg) compared to 0.1% for placebo. In a key secondary endpoint, from a baseline weight of 189 lb., Mounjaro reduced participants’ weight by a mean of 14 lb. (5 mg), 15 lb. (10 mg) and 17 lb. (15 mg) compared to 2 lb. for placebo.
SURPASS-2 (NCT03987919) was a 40-week study comparing the efficacy and safety of Mounjaro 5 mg (n = 470), 10 mg (n = 469) and 15 mg (n = 469) to injectable semaglutide 1 mg (n = 468) in adults with type 2 diabetes inadequately controlled with ≥1,500 mg/day metformin alone.
From a baseline A1C of 8.3%, Mounjaro reduced participants’ A1C by a mean of 2.0% (5 mg), 2.2% (10 mg) and 2.3% (15 mg) compared to 1.9% for semaglutide. In a key secondary endpoint, from a baseline weight of 207 lb., Mounjaro reduced participants’ weight by a mean of 17 lb. (5 mg), 21 lb. (10 mg) and 25 lb. (15 mg) compared to 13 lb. for semaglutide.
SURPASS-3 (NCT03882970) was a 52-week study comparing the efficacy of Mounjaro 5 mg (n = 358), 10 mg (n = 360) and 15 mg (n = 358) to titrated insulin degludec (n = 359) in adults with type 2 diabetes treated with metformin with or without an SGLT-2 inhibitor.
From a baseline A1C of 8.2%, Mounjaro reduced participants’ A1C by a mean of 1.9% (5 mg), 2.0% (10 mg) and 2.1% (15 mg) compared to 1.3% for insulin degludec. From a baseline weight of 208 lb., Mounjaro reduced participants’ weight by a mean of 15 lb. (5 mg), 21 lb. (10 mg) and 25 lb. (15 mg) compared to an increase of 4 lb. for insulin degludec.
SURPASS-4 (NCT03730662) was a 104-week study comparing the efficacy and safety of Mounjaro 5 mg (n = 328), 10 mg (n = 326) and 15 mg (n = 337) to insulin glargine (n = 998) in adults with type 2 diabetes inadequately controlled with at least one and up to 3 oral anti-hyperglycaemic medications (metformin, sulfonylureas or SGLT-2 inhibitors), who have increased cardiovascular (CV) risk. The primary endpoint was measured at 52 weeks.
From a baseline A1C of 8.5%, Mounjaro reduced participants’ A1C by a mean of 2.1% (5 mg), 2.3% (10 mg) and 2.4% (15 mg) compared to 1.4% for insulin glargine. From a baseline weight of 199 lb., Mounjaro reduced weight by a mean of 14 lb. (5 mg), 20 lb. (10 mg) and 23 lb. (15 mg) compared to an increase of 4 lb. for insulin glargine.
SURPASS-5 (NCT04039503) was a 40-week study comparing the efficacy and safety of Mounjaro 5 mg (n = 116), 10 mg (n = 118) and 15 mg (n = 118) to placebo (n = 119) in adults with inadequately controlled type 2 diabetes already being treated with insulin glargine, with or without metformin.
From a baseline A1C of 8.3%, Mounjaro reduced A1C by a mean of 2.1% (5 mg), 2.4% (10 mg) and 2.3% (15 mg) compared to 0.9% for placebo. From a baseline weight of 210 lb., Mounjaro reduced participants’ weight by a mean of 12 lb. (5 mg), 17 lb. (10 mg) and 19 lb. (15 mg) compared to an increase of 4 lb. for placebo.
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