GLP‑1 news from 2015
4 dated, sourced GLP-1 developments from 2015: approvals, trial results, prices, lawsuits, compounding and culture.
- Business
Lixisenatide shows no heart benefit and no harm in 6,068-patient ELIXA trial
In the ELIXA trial, 6,068 patients with type 2 diabetes and a recent acute coronary syndrome were randomly assigned to lixisenatide or placebo and followed for a median of 25 months. A primary cardiovascular event occurred in 406 patients (13.4%) taking lixisenatide and 399 (13.2%) taking placebo, a hazard ratio of 1.02 (95% CI, 0.89 to 1.17). The drug met the trial's noninferiority bar but showed no superiority, and rates of heart failure hospitalization, death, and serious adverse events did not differ significantly between groups.
- Business
Liraglutide resolved NASH in 39% of patients in small UK trial
A 52-patient phase 2 trial in the United Kingdom found that liraglutide resolved non-alcoholic steatohepatitis in 9 of 23 treated patients (39%) versus 2 of 22 on placebo (9%), with less fibrosis progression in the liraglutide group. Results were published Nov. 20, 2015. The authors called for larger, longer-term studies, and liraglutide was not studied here for any other GLP-1 medicine.
- Business
Liraglutide 3.0 mg produced 6% weight loss in type 2 diabetes, SCALE Diabetes trial finds
In the SCALE Diabetes trial, 846 adults with type 2 diabetes and excess weight were assigned to daily liraglutide 3.0 mg, liraglutide 1.8 mg or placebo for 56 weeks, alongside diet and exercise. The 3.0 mg group lost an average of 6.0% of body weight, compared with 4.7% at 1.8 mg and 2.0% on placebo. The trial, reported in JAMA, found more gastrointestinal side effects at the higher dose and no cases of pancreatitis.
- Research and trials
Liraglutide 3.0 mg produced more weight loss than placebo in 56-week trial
In the SCALE Obesity and Prediabetes trial published July 2, 2015, 3,731 adults without type 2 diabetes lost a mean of 8.4 kg on liraglutide 3.0 mg versus 2.8 kg on placebo over 56 weeks. About 63% of the liraglutide group lost at least 5% of body weight versus 27% on placebo, and 33% versus 11% lost more than 10%. Mild or moderate nausea and diarrhea were the most frequently reported side effects.