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Ascletis Wins FDA Green Light for Phase II U.S. Diabetes Trial of Oral GLP-1 Drug ASC30

Story Highlights
  • Ascletis secured FDA clearance for a 13-week Phase II U.S. trial of ASC30 in type 2 diabetes patients, starting enrollment in early 2026.
  • Positive obesity Phase II data and favorable tolerability support ASC30’s potential, strengthening Ascletis’ position in the competitive GLP-1 metabolic market.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Ascletis Wins FDA Green Light for Phase II U.S. Diabetes Trial of Oral GLP-1 Drug ASC30

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Ascletis Pharma, Inc. ( (HK:1672) ) has provided an update.

Ascletis Pharma has received U.S. FDA Investigational New Drug clearance to launch a 13-week Phase II clinical trial of its oral small molecule GLP-1 receptor agonist ASC30 in participants with type 2 diabetes, with enrollment of about 100 U.S. patients expected to start in the first quarter of 2026. The randomized, double-blind, placebo-controlled, multi-centre study will assess changes in HbA1c as the primary endpoint, alongside fasting blood glucose, body weight, and safety, positioning ASC30 as a potential entrant in the sizeable diabetes treatment market. The decision follows a completed 13-week U.S. Phase II trial in obesity and overweight patients where ASC30 achieved up to 7.7% placebo-adjusted weight loss with favourable gastrointestinal tolerability and low discontinuation rates, reinforcing Ascletis’ bid to compete in the increasingly crowded GLP-1 space and potentially broaden its presence in global metabolic disease therapeutics.

The most recent analyst rating on (HK:1672) stock is a Hold with a HK$17.00 price target. To see the full list of analyst forecasts on Ascletis Pharma, Inc. stock, see the HK:1672 Stock Forecast page.

More about Ascletis Pharma, Inc.

Ascletis Pharma Inc. is a Cayman Islands–incorporated biopharmaceutical company listed in Hong Kong that focuses on discovering and developing innovative therapies for metabolic and other diseases. Its pipeline includes ASC30, an in-house discovered oral small molecule GLP-1 receptor agonist being developed for obesity, diabetes and related metabolic conditions.

Average Trading Volume: 6,021,073

Technical Sentiment Signal: Buy

Current Market Cap: HK$11.43B

For a thorough assessment of 1672 stock, go to TipRanks’ Stock Analysis page.

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