Patients with type 2 diabetes achieved 6% weight loss with liraglutide 3 mg in a phase 3a obesity trial, according to Novo Nordisk.
This is the second phase 3a trial to be completed as part of SCALE (Satiety and Clinical Adiposity – Liraglutide Evidence in Non-Diabetic and Diabetic Subjects), the clinical development program for liraglutide 3 mg as an obesity treatment.
From a mean baseline weight of approximately 106 kg and a body mass index of 37, the weight loss for people treated with liraglutide 3 mg and liraglutide 1.8 mg after 56 weeks were 6% and 5%, respectively compared to a 2% weight loss for people treated with placebo, according to a company statement.
The proportion of people achieving a weight loss of at least 5% or 10% was 50% and 22% for liraglutide 3 mg, 35% and 13% for liraglutide 1.8 mg, and 13% and 4% for placebo treatment. All differences for both doses of liraglutide were statistically significantly different from placebo and the trial met all three co-primary end points. During the 12-week follow-up period after treatment discontinuation, patients in both liraglutide treatment groups experienced a moderate weight regain.
“We are pleased about the outcome of this trial and look forward to getting the results from the two remaining trials in the SCALE program,” Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk, said in a press release. “This SCALE trial shows that it is possible to achieve both clinically significant weight loss and excellent glucose control with a single treatment in patients with type 2 diabetes. Weight management is often a greater challenge for this patient population and there is a need for new and effective treatment options.”
Starting from a baseline HbA1C of 8.0%, approximately 69%, 67%, and 27% of people treated with liraglutide 3 mg, liraglutide 1.8 mg, and placebo achieved the HbA1C treatment target of 7% recommended by the American Diabetes Association and the European Association for the Study of Diabetes. In the trial, the rate of hypoglycemia was comparable to that observed in previous trials with liraglutide, according to Novo Nordisk.
In the trial, liraglutide was generally well tolerated and the 56-week completion rate was 77%, 78%, and 66% for liraglutide 3 mg, liraglutide 1.8 mg, and placebo, respectively. Withdrawals due to adverse events were below 10% in all treatment groups. In line with previous liraglutide trials, the most common adverse events were related to the gastrointestinal system and diminished over time. No other apparent differences between the treatment groups were observed with respect to adverse events and standard safety parameters.
“The difference in weight loss between 1.8 mg and 3 mg of liraglutide is small, although comparable to FDA-approved anti-obesity agents that are currently available,” said MaryBeth Derbyshire, PharmD, managed care pharmacy resident, Health Plan of San Joaquin, Stockton, Calif.
“However, it remains critical to balance the incremental benefit of a 1% difference in weight loss with the increase in adverse effects,” Dr. Derbyshire said. “According to previous studies, more gastrointestinal side effects are associated with liraglutide 3 mg than with liraglutide 1.8 mg, 71.0% versus 60%, respectively. Therefore, increasing the dosage of liraglutide for additional weight loss leads to an increased risk of adverse effects. Furthermore, additional safety concerns for liraglutide have been generated by the recent FDA announcement regarding the potential increased risk of pancreatitis and pancreatic duct metaplasia. These safety concerns need to be weighed against the efficacy of liraglutide for the treatment of obesity to ensure that the benefits outweigh the risks.”