A novel weight loss drug in the same class as semaglutide has successfully met its targets in its largest clinical trial yet, with nearly 90% of participants losing at least 5% of their body weight. The results strengthen its case for US Food and Drug Administration approval.
Known as ecnoglutide, the drug is a cyclic adenosine monophosphate (cAMP)-biased glucagon-like peptide-1 (GLP-1) receptor agonist, which may be more effective in targeting weight loss and insulin secretion due to the single pathway it activates within cells.
The Phase III SLIMMER trial by researchers at the Peking University People’s Hospital in China, involved 664 overweight or obese participants without diabetes, who were randomly assigned once-weekly ecnoglutide (either 1.2, 1.8, or 2.4 mg doses) or a placebo for 48 weeks.
Those taking ecnoglutide lost, on average, 9-13% of their body weight after 40 weeks, while people who received the placebo experienced little to no weight change. Side effects were minimal, with the most common being mild digestive upsets, similar to that of semaglutide (Ozempic and Wegovy). A majority (77-87%) of participants taking ecnoglutide lost 5% or more of their body weight.
"The rates of treatment discontinuation due to adverse events were low and comparable across the three ecnoglutide groups, suggesting a favourable safety profile associated with all three doses of ecnoglutide," the researchers wrote.
Interestingly, in the table of countries of the world testing weight-loss drugs, China is in the second spot, behind the US. And while only 6% of the population is classified as obese, compared to an estimated 40% of Americans, its massive population means there's still a big market for these medications.
Ecnoglutide has shown promise in smaller studies, but this is the first large Phase III trial, which primarily assessed the drug's safety and efficacy. Next-generation GLP-1 therapeutics like ecnoglutide aim to improve efficacy and tolerability of obesity medications, as well as simplify manufacturing in order to lower the cost of production.
The researchers noted that participants on the higher ecnoglutide doses continued to lose weight through to week 48, so the drug may benefit people who haven't gotten the results they wanted on other GLP-1 treatments.
"Weight reductions in the ecnoglutide 1.8-mg and 2.4-mg groups had not reached a plateau by the end of the study period," the scientists noted.
As such, the team reported that ecnoglutide may produce continued weight loss that surpasses the results seen in this trial, which had a specific end date.
"Once-weekly injections of ecnoglutide, a novel, cAMP-biased GLP-1 receptor agonist, at doses of 1.2, 1.8, and 2.4 mg demonstrated superior and sustained weight reduction versus placebo in a dose-dependent manner, with metabolic benefits and a favorable safety profile, supporting its potential use as a treatment option for individuals with overweight and obesity," the researchers concluded.
The study was published in the journal The Lancet Diabetes & Endocrinology.
Source: Peking University People’s Hospital via Scimex