Type 2 diabetes treatment Ozempic has become the biggest name in the weight-loss drug market, but it's far from the only option available at this point. Novo Nordisk, which makes Ozempic, has an option prescribed for weight loss (Wegovy), as do other brands like Eli Lilly, which makes Zepbound. Now, drug manufacturer Altimmune is on the scene, announcing positive results from a study of its new drug, pemvidutide. Following 48 weeks of treatment, a third of patients taking pemvidutide lost 20 percent or more of their body weight.
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The MOMENTUM trial of pemvidutide included 391 participants with obesity (or who were overweight) and at least one comorbidity, and without diabetes, per a Nov. 30 press release from Altimmune. At the start of the study, subjects had an average age of 50 years and an average weight of 229 pounds (104 kilograms). Seventy-five percent of the participants were female.
Participants were randomly assigned to receive a 1.2-milligram, 1.8-milligram, or 2.4-milligram dose of pemvidutide, or placebo, which they took once a week for 48 weeks while also dieting and exercising. Those who received the 2.4-milligram dose went under a four-week titration period (starting at a lower level and working up to the 2.4-milligram dose).
At the 48-week mark, those receiving the 2.4-milligram dose lost 15.6 percent of their body weight, while those on the 1.8-milligram dose lost 11.2 percent, and those on the 1.2-milligram dose lost 10.3 percent. Participants who took the placebo lost just 2.2 percent of their body weight.
The press release noted that over 50 percent of participants lost at least 15 percent of their body weight—and even more notably, 30 percent of those on the highest dose lost 20 percent or more of their body weight.
“To put these results in context, the 15.6% mean weight loss observed with the 2.4 mg dose was associated with a mean weight loss of 32.2 lbs at 48 weeks," Vipin K. Garg, PhD, president and CEO of Altimmune, said in the press release. "The impact of this level of weight loss on patients can be significant. For example, 48% of subjects on the 2.4 mg dose with baseline obesity no longer had obesity at the end of the 48-week trial.”
Study participants also experienced additional health benefits, including reductions in "bad" cholesterol (LDL cholesterol), triglycerides (which can increase your risk of heart disease at high levels), and blood pressure.
"We believe the magnitude of weight loss, robust reductions in triglycerides, LDL cholesterol and blood pressure, together with the safety profile observed in this trial, could potentially differentiate pemvidutide from the other incretin-based therapies," Garg said in the release.
Incretins are a potential target for obesity treatment, as the incretin system consists of hormones that appear to contribute to weight loss.
RELATED: New Drug Has People Losing 19% of Body Weight, Research Shows—And It's Not Ozempic.
However, there were some adverse events (AEs) reported during the study, with nausea and vomiting the most common, ranging from mild to moderate in severity. No AEs of special interest or major adverse cardiac events were noted, but one serious adverse event (SAE) was reported by a patient taking the 2.4-milligram dose, which was a case of vomiting.
AEs caused 6.2 percent of those taking placebo to discontinue treatment, and 5.1 percent, 19.2 percent, and 19.6 percent of those taking the 1.2, 1.8, and 2.4-milligram doses, respectively, to stop treatment. Some discontinued the study too, with most discontinuation due to AEs in the treatment groups occurring in the first 16 weeks of treatment. The press release also noted that more patients who received pemvidutide completed the trial than those who received placebo (74 percent vs. 61.9 percent, respectively).
According to the press release, pemvidutide is a peptide-based glucagon-like peptide 1 (GLP-1)/glucagon duel receptor agonist. When the GLP-1 and glucagon receptors are activated, it mimics the effects of diet and exercise, the release noted, while GLP-1 also suppresses appetite. It is in development for the treatment of obesity as well as liver disease metabolic dysfunction-associated steatohepatitis (MASH), formerly known as non-alcoholic steatohepatitis (NASH). In October, the U.S. Food and Drug Administration (FDA) granted Altimmune Fast Track designation for pemvidutide for the treatment of MASH.
"If approved, we believe pemvidutide could offer an important option for obesity patients, including those with risk factors for cardiovascular disease," Garg said in the release.
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