Novo Nordisk’s latest weight loss treatment, CagriSema, did not meet the primary endpoint of showing non-inferiority compared to tirzepatide, the company announced on Monday.
Novo Nordisk facility in Kalundborg, Denmark. Credit: Novo Nordisk
CagriSema, a combination of cagrilintide and semaglutide, achieved 23% weight loss after 84 weeks of treatment, compared to 25.5% with tirzepatide. The treatment was safe and well tolerated, with mostly mild to moderate gastrointestinal adverse effects reported, consistent with other GLP-1s, the company said.
“We are pleased with the weight loss of 23% for CagriSema in this open-label trial. Based on the learnings from completed studies we look forward to the REDEFINE 11 readout, and the initiation of the higher-dose CagriSema trial, which are both designed to assess the full weight-loss potential of CagriSema”, said Martin Holst Lange, executive vice president, R&D and chief scientific officer at Novo Nordisk.
In a call with investors, Martin Lange, EVP of R&D, chief scientific officer and member of the Management Board, explained that CagriSema performed inline with the company’s Phase 1 trial, while tirzepatide “performed unusually well on efficacy compared to what has typically been reported in most previous trials of similar nature.”
“We are a little bit surprised about the 25% weight loss that we see with the comparator drug,” he said, “We believe that it is largely derived from the open-label nature of this study. In this case, more than 40% of the investigators are previous investigators on the comparator drug. They know the drug well. They have probably prescribed the drug and they feel confident in the drug.”
“We strongly believe that CagriSema has right now the best weight efficacy than any product currently in the market,” he added.
Novo Nordisk stock is down 16% Monday afternoon following the announcement.
CagriSema was submitted to the FDA in December 2025, and Novo Nordisk expects a decision by late 2026, the company said. The Phase 3 trial results are expected during the first half of 2027, with a Phase 3 trial for a higher dose planned for the second half of this year.
Upcoming on Novo Nordisk’s pipeline
Novo Nordisk also recently introduced Wegovy High Dose, which is approved in the EU and U.K. A U.S. decision is expected by the end of the first quarter of 2026, President and CEO Maziar Mike Doustdar said on an investor call.
The company’s next-generation GLP-1, zenagamtide, showed up to 24% weight loss after 36 weeks in a Phase 2 trial. Novo Nordisk plans to make this treatment available as an injection or an oral pill, Doustdar said. The company will also be offering cagrilintide as a monotherapy, he added.
Filed Under: Endocrinology, Gastroenterology, Metabolic disease/endicrinology
Tagged With: cagrilintide, CagriSema, clinical trial, FDA, GLP-1, non-inferiority, Novo Nordisk, obesity, Phase 3, pipeline, semaglutide, Tirzepatide, Wegovy, weight loss, zenagamtide