Phase II clinical trial shows a fixed dose combination of semaglutide/cagrilintide reduces HbA1c and weight much better than either drug alone.
Novo Nordisk announced Monday topline results from a phase II clinical trial of its once-weekly subcutaneous combination of the glucagon-like peptide-1 receptor agonist semaglutide and a novel amylin analogue, cagrilintide (CagriSema).
The most provocative finding associated with the fixed-dose combination administered to patients with type 2 diabetes (T2D) and overweight was a reduction in body weight of 15.6% in this group compared to groups treated with either of the drugs dosed individually, according to a Novo Nordisk statement.
The phase II study evaluated the safety and efficacy of once weekly administration of a combination of semaglutide 2.4 mg and cagrilintide 2.4 mg compared to either of the components given alone, both dosed at both 2.4 mg.
Among the trial’s 92 participants, the mean baseline HbA1c was 8.4% and mean baseline body weight, 106 kg. The cohort was equally randomized among the 3 treatment arms and the treatment period was 32 weeks.
Among the key results reported, participants who received the combination of semaglutide/cagrilinitide had a greater mean numerical reduction in HbA1c (2.18%) compared with those treated with either of the individual components alone: semaglutide, 1.79% and cagrilintide, 0.93%.
Participants in the semaglutide/cagrilinitide-treated arm achieved a reduction in body weight of 15.6% compared to a reduction of 5.1% in the semaglutide-only arm and of 8.1% in the cagrilintide-only arm.
“We are encouraged by the impressive phase 2 results for CagriSema in people with type 2 diabetes,” said Martin Holst Lange, executive vice president for Development at Novo Nordisk. “The results indicate that CagriSema reduces blood sugar more than semaglutide alone and the weight loss seen in the trial confirms the substantial weight lowering potential of CagriSema.
Building on these results, Novo Nordisk plans 2 phase III development plans for the semaglutide/cagrilinitide combination. The REDEFINE program will enroll persons with overweight and obesity and is expected to begin in the fourth quarter of this year. The company will initiate a phase III program to assess the combination in persons with T2D in 2023, according to the statement.