Novo Nordisk Launches Clinical Trial in China for Once-Weekly Obesity Drug Cagrilintide (NNC0174-0833)

By | Pharma Observer

Recently, the Chinese Clinical Trial Registry and Information Disclosure Platform indicated that Novo Nordisk has initiated a clinical trial in China to investigate the mechanism of action of NNC0174-0833 (cagrilintide) in Chinese subjects with normal weight, overweight, or obesity. Cagrilintide, an amylin analogue under development by Novo Nordisk, has previously demonstrated efficacy in the treatment of obesity in Phase 2 clinical trials.

Screenshot Source: Chinadrugtrials

Cagrilintide is a long-acting amylin analog with a half-life of approximately 7–8 days. Amylin is another hormone associated with hunger and satiety that functions independently of the GLP-1 signaling pathway. It has been reported that amylin reduces energy intake, modulates food choice and preference, and, through co-secretion with insulin, exerts glucose-regulatory effects by suppressing postprandial glucagon release and delaying gastric emptying.

Novo Nordisk has initiated a pharmacokinetic study in China evaluating a single subcutaneous injection of cagrilintide in Chinese male subjects with normal weight, overweight, or obesity. The objective of this study is to assess the behavior of the investigational drug in participants' bodies and its clearance from their systems. Notably, the study will exclusively enroll Chinese male subjects aged 18 to 55 years (inclusive), with a body weight ranging from 60.0 to 110 kg and a body mass index (BMI) between 20.0 and 39.9 kg/m².

According to a study published in *The Lancet* this April, combination therapy with cagrilintide and semaglutide was well tolerated and demonstrated an acceptable safety profile in a phase 1b clinical trial. In this trial, 96 subjects were randomized to either the cagrilintide group (0.16–2.4 mg, n = 12; 4.5 mg, n = 11) or the placebo group (n = 24), in combination with 2.4 mg semaglutide. Of these, 95 subjects were exposed to treatment and included in the safety and full analysis sets.

The results showed that at Week 20, the mean percentage body weight reduction in the cagrilintide 1.2 mg and 2.4 mg groups (-15.7% and -17.1%, respectively) was greater than that in the placebo group (-9.8%). The estimated treatment differences between the cagrilintide 1.2 mg and 2.4 mg groups versus placebo were -6.0% and -7.4%, respectively. Additionally, the mean percentage body weight reduction with cagrilintide 4.5 mg in combination with semaglutide 2.4 mg (-15.4%) was also significantly greater than that in the placebo group (-8.0%). Most adverse events in the study were mild to moderate in severity, and the proportion of participants experiencing one or more adverse events was similar across treatment groups.

According to World Health Organization statistics, the global number of individuals with obesity has nearly tripled since 1975, with over 1.9 billion adults currently overweight. Obesity is associated with an increased risk of various diseases, including type 2 diabetes, cancer, and cardiovascular diseases. Historically, however, effective treatments for weight reduction have been severely limited. This June, the U.S. FDA approved Wegovy (semaglutide), developed by Novo Nordisk, for the long-term treatment of obesity. Furthermore, a new generation of weight-loss therapies, including amylin analogs, is continually emerging.

References:

[1]Drug Clinical Trial Registration and Information Disclosure Platform. Retrieved Nov 2, 2021, from http://www.chinadrugtrials.org.cn/clinicaltrials.searchlistdetail.dhtml

[2] Lbe A , Kkb A , Mk B , et al. Safety, tolerability, pharmacokinetics, and pharmacodynamics of concomitant administration of multiple doses of cagrilintide with semaglutide 2•4 mg for weight management: a randomised, controlled, phase 1b trial. 2021.

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