The sub-analysis, presented at the European Association for the Study of Diabetes congress, showed improved safety data to counteract past tolerability issues.
Novo Nordisk’s long-acting amylin analog cagrilintide reduced body weight by 11.8% after 68 weeks of treatment, according to a sub-analysis of a late-stage trial evaluating the drug.
The data, presented Tuesday at the European Association for the Study of Diabetes (EASD) congress, came from the company’s REDEFINE 1 Phase III trial. This is the first time Novo has presented late-stage data for the hopeful next-generation amylin treatment as a monotherapy.
The candidate “provided clinically meaningful weight loss,” according to Novo, with the 11.8% weight reduction comparing to 2.3% in patients who received a placebo, in combination with lifestyle changes.
Novo touted cagrilintide as being “well-tolerated,” with just 1% of patients who received the drug discontinuing, compared to 0.1% in the placebo arm. Side effects were mostly gastrointestinal, including nausea, vomiting, diarrhea and constipation, which are all commonly reported adverse events for approved weight loss drugs.
“These data highlight the exciting potential of cagrilintide to offer an alternative approach for people to lose weight, achieve health-related outcomes and manage their obesity, including a favorable tolerability profile,” Timothy Garvey, the study’s lead investigator and director of the Diabetes Research Center at the University of Alabama at Birmingham, said in a statement.
The update is a step in the right direction for Novo’s candidate, which has previously been dinged by tolerability concerns in prior readouts. A previous readout from REDEFINE 1 testing CagriSema—a combination of cagrilintide and Novo’s GLP-1 agonist semaglutide—found that 12% of patients reported injection-site reaction adverse events.
When patients received each drug separately, however, 2.6% of patients taking semaglutide reported the same events, compared to 17% of patients on cagrilintide, leading William Blair analysts in June to conclude that the reactions were “primarily due to the cagrilintide component” of CagriSema.
Novo will evaluate cagrilintide’s safety and efficacy in people with obesity or who are overweight in a dedicated Phase III trial called RENEW, set to begin in the fourth quarter, according to Novo’s statement.
Novo is, as ever, jostling with obesity market rival Eli Lilly. The rival will present further data for oral candidate orforglipron at EASD from the Phase III ATTAIN-1 trial on Wednesday. Initial results from that trial were met with shrugs when the drug failed to generate as much weight loss as injectable semaglutide, in data announced in early August.
Nevertheless, Lilly is racing to get orforglipron approved as soon as possible, with the aim to beat a next-generation Novo product to market. Lilly could reportedly benefit from the use of the FDA’s newly launched Commissioner’s Priority Voucher to score a one-to-two-month review on orforglipron. However, according to Lilly, it is “too early” to know if the company can qualify for the voucher.
