Mounjaro(tirzepatide)

Mounjaro (tirzepatide) is a drug indicated for the treatment of type 2 diabetes. In clinical trials, tirzepatide demonstrated significant reductions in HbA1c and fasting serum glucose (FSG) compared to placebo and insulin comparators.

Specifically, tirzepatide showed HbA1c effect sizes of -1.33 to -1.56% versus placebo (GPGI) and -0.6 to -0.91% versus insulin degludec (GPGH) at Week 52. For placebo (GPGI), mean FSG at baseline was 164.4 mg/dL, reducing to 123.4 mg/dL at Week 40, with 29.1% of subjects achieving FSG <100 mg/dL. For insulin degludec (GPGH), mean FSG at baseline was 166.6 mg/dL, reducing to 118.8 mg/dL at Week 52, with 25.7% of subjects achieving FSG <90 mg/dL. The background insulin glargine dose for placebo (GPGI) increased by 10 to 59 units/day, and for insulin degludec (GPGH) by 10 to 49 units/day.

Safety findings included Level 2 or Level 3 hypoglycemia rates of 13.3% for placebo (GPGI), 7.3% for insulin degludec (GPGH), and 20% for insulin glargine (GPGM). Tirzepatide also led to reductions in the AUCtau and Cmax of ethinyl estradiol, norelgestromin, and norgestimate, with Cmax reductions ranging from 55% to 66%. The FDA review process involved multiple comment rounds and supplement submissions.