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12 weeks 13% weight loss
New Oral Weight Loss Pill Reduces Body Weight by 13% in 12 Weeks
Amycretin, a novel oral weight loss medication, demonstrated up to 13% body mass reduction within three months, hinting at sustained potential for continued weight loss. Although generally well-tolerated, its long-term safety and effectiveness remain to be thoroughly assessed.
In a recent presentation at the European Association for the Study of Diabetes (EASD) annual conference, held in Madrid, Spain (September 9-13), findings revealed that individuals taking this once-daily oral medication experienced up to 13% weight reduction in just three months.
Developed by the Danish pharmaceutical giant Novo Nordisk A/S, Amycretin emulates the actions of two critical peptide hormones within a singular molecular structure.
This medication acts as both an amylin and glucagon-like peptide-1 (GLP-1) receptor agonist. These biological pathways are fundamental in appetite control and hunger regulation, and have been associated with significant weight loss effects.
12 weeks 13% weight loss: Current Treatments and Study Design
Currently, GLP-1 therapies are predominantly administered via injections, as are amylin-based treatments undergoing clinical trials. No oral treatments have yet targeted both pathways simultaneously.
The phase 1, single-center, placebo-controlled, double-blind study enrolled adults with a BMI of 25.0-39.9 kg/m², none of whom had diabetes. Participants were randomly assigned to receive either Amycretin or a placebo, taken once daily over a 12-week period.
The trial, conducted by Novo Nordisk A/S alongside a clinical research facility in the U.S., followed a rigorous protocol featuring both single- and multiple-ascending dose phases. These phases explored various dosages of orally administered Amycretin, ranging from an initial single dose of 1 mg up to 25 mg, and stepwise increments during the 10-day and 12-week periods, culminating in a maximum tested dose of 2×50 mg.
In this first-in-human study, Amycretin presented a safety and tolerability profile consistent with the drug’s receptor classes. Most side effects were mild to moderate, predominantly gastrointestinal in nature, including nausea and vomiting.
Weight Loss Outcomes
By the conclusion of the trial, those receiving Amycretin experienced more pronounced weight loss compared to the placebo group. Participants administered 50 mg of Amycretin saw an average weight reduction of 10.4% within 12 weeks. Meanwhile, individuals receiving the maximum dose of 2×50 mg achieved an average reduction of 13.1% in body weight, contrasting with the placebo group’s modest 1.1% weight reduction.
Importantly, weight loss did not plateau for those taking Amycretin by the study’s end, suggesting that extended use may foster further weight reduction.
The study’s authors concluded that daily oral Amycretin treatment in adults with overweight or obesity, but without diabetes, demonstrated a favorable safety profile aligned with the drug receptor classes, as well as notable weight loss.
They remarked, “A single molecule that targets both amylin and GLP-1 pathways in tablet form could present a more convenient solution for individuals struggling with obesity or excess weight.”
However, they caution that larger, more extended trials are essential to comprehensively evaluate the drug’s safety and efficacy.
Presented at the Annual Meeting of the European Association for the Study of Diabetes (EASD).