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Two Novel Weight Loss Drugs Show Promise in Early Trials
By Andrew John, MD /alert ContributorSave to PDF October 2, 2024
Two novel weight-loss drugs appeared effective and well-tolerated in early clinical trials, according to recently published topline results. Both drugs are dual-acting GLP1-receptor agonists, though their individual properties differ significantly.
Dapiglutide
Dapiglutide, a GLP-1/GLP-2 receptor dual agonist, appeared safe and efficacious in a phase 1b ascending dose trial. The single-center, randomized, double blind placebo-controlled study is being conducted in two parts, with data from the first part released in September by the drug manufacturer.
In part 1, researchers randomly assigned 54 patients to receive either placebo or dapiglutide at a 14:4 ratio. All patients received one dose a week for 13 weeks and were divided into three cohorts according to dosage. Patients were mostly men (85%), and the median age was 46. Their baseline BMI was 30 kg/m2.
By the 13-week mark, patients assigned to the study drug experienced placebo-adjusted reductions in body weight of up to 8.3%, with weight loss up to a mean of 6.2% among patients assigned to dapiglutide versus 2.1% weight gain in patients assigned to placebo, according to the press release.
The most common treatment-emergent adverse events included nausea and vomiting. Rates gastrointestinal adverse events were consistent with those seen in similar trials of drugs like dapiglutide, according to the manufacturer.
Part 2 of the trial will test the drug at higher doses. Zealand said the topline data from that portion of the study would be available in early 2025.
Amycretin
An abstract presented at the European Association for the Study of Diabetes Annual Meeting 2024 showed oral amycretin, a novel agonist of both GLP-1 and the hormone amylin, produced significant weight loss in a short amount of time.
In a first-in-human randomized clinical trial, researchers randomly assigned patients with BMIs ranging from 25 to 39.9 kg/m2 to receive either oral placebo (n = 29) or amycretin once a day. Patients were ineligible for the study if they had diabetes.
The researchers performed the study in three parts. Part A used a single-ascending dose design, evaluating doses ranging from 1 mg to 25 mg; Part B used a 10-day multiple ascending-dose design for doses ranging from 3 to 12 mg; and Part C used a 12-week multiple-ascending dose approach, evaluating two 50-mg doses.
At 12 weeks, patients assigned to a 50-mg dose of amycretin lost an average of 10.4% (standard deviation [SD] = 4.6), whereas those assigned to two 50-mg doses lost an average of 13.1% (SD = 4.8), compared to just 1.6% weight loss in the placebo group, according to the researchers (SD = 2.6; P < .0001 for both).
As with dapiglutide, adverse events were reported to be mostly gastrointestinal, especially nausea and vomiting, the researchers reported. Adverse events occurred proportional to dosage. Researchers said that all tested dose levels up to two 50-mg doses were safe and tolerable.
The researchers noted that additional studies of amycretin are planned for the near future.
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Disclosures: The first study is being supported by Zealand Pharma. The second study was supported by Novo Nordisk.
Photo Credit: Getty Images.
