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Monthly amylin shot and combo peptide start U.S. safety trials for obesity

A drug company called Ascletis just started two early-stage clinical trials in the U.S. testing monthly injectable treatments for obesity. These are Phase I studies, which means the main goals are to check safety and how the drugs behave in the body, not to prove they work to shed large amounts of weight yet. The two versions being tested are a single drug called ASC36 and a combination shot called ASC36_35FDC that mixes ASC36 with another peptide drug. ASC36 is described as an amylin receptor peptide agonist. In plain terms, that means it’s a lab-made version of a small protein that acts like amylin, a natural hormone your body makes alongside insulin after you eat. Amylin helps signal fullness to the brain and slows how quickly the stomach empties, so mimicking it can reduce appetite and food intake. The other half of the combo, the GLP-1R/GIPR peptide, refers to drugs that imitate other gut hormones (GLP‑1 and GIP) that also curb appetite and affect blood sugar and metabolism. So ASC36_35FDC is a monthly shot combining the amylin mimic with a drug that targets those other appetite-regulating receptors. Because these are Phase I trials, the research is mostly about safety, dosing, and basic behavior in humans — not large-scale effectiveness. The announcement only says the studies have started; it doesn’t report results, how many people are enrolled, or any weight-loss numbers. That means we should expect several months to a couple of years of testing before there’s meaningful data on whether the injections substantially reduce weight, and whether monthly dosing is practical and well tolerated. Why this matters is that weight-loss treatment has been changing fast in recent years as new injectable peptide drugs have shown larger effects than older medications. A monthly injection that safely reduces appetite and body weight would be attractive because it’s more convenient than weekly or daily shots. People with obesity, clinicians, and the healthcare system could all be interested if the drugs prove safe and effective because they might expand options beyond current medicines like semaglutide (the active ingredient in Ozempic/Wegovy), which are typically weekly. There are important caveats. Phase I trials are small and focused on safety, so starting them is only the first step and many drugs don’t make it through later phases. Peptide drugs can have side effects such as nausea, vomiting, or impacts on the pancreas and gallbladder; we don’t yet know the safety profile for ASC36 or the combo version. Regulatory approval will require larger trials showing clear benefit and acceptable risks. Until published data appear from these studies, we don’t know how well these monthly injections will work or who should or shouldn’t use them. Bottom line: Ascletis has begun early human testing of a monthly amylin-mimicking shot and a combo shot with GLP‑1/GIP activity for obesity, but it will take more and larger studies to learn whether they are safe and effective.

Source: PR Newswire

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