Ascletis Enters the Obesity Drug Spotlight with Bold Play on Oral GLP-1 Candidate

Ascletis Pharma has unveiled promising topline results from its U.S.-based Phase 1b trial of ASC30, its once-daily oral GLP-1 receptor agonist, positioning the molecule as a serious contender in the booming obesity market. The data support a pivot toward a slower, more tolerable dose-escalation strategy ahead of a Phase 2a study set to launch in Q3 2025.

The randomized, double-blind, placebo-controlled Phase 1b multiple ascending dose (MAD) study enrolled adults with obesity (BMI 30–40 kg/m²) and evaluated three weekly titration schemes over four weeks. Schemes 1 and 2 (starting at 2 mg) demonstrated placebo-adjusted weight loss of 4.5% and 6.5%, respectively. Scheme 2 achieved a maximum individual weight loss of 9.1%, with no evidence of plateauing. Importantly, gastrointestinal (GI) side effects were mostly mild and transient—Scheme 1 reported no vomiting at all.

Scheme 3, which began at a higher dose (5 mg) and escalated rapidly to 60 mg, showed similar efficacy—6.1% placebo-adjusted weight loss after excluding two low-response outliers—but with worsened GI tolerability. This reinforced the case for a “low and slow” dose titration, particularly given the absence of serious adverse events or liver enzyme elevations across all cohorts.

ASC30 is a first-in-class small molecule GLP-1R biased agonist, designed in-house to be administered either as a once-daily oral tablet or once-monthly subcutaneous injection. The oral formulation is central to Ascletis’ metabolic disease strategy as the company aggressively reallocates R&D resources from virology and oncology toward obesity.

Phase 2a plans are already in motion. Ascletis has submitted a 13-week protocol to the FDA, incorporating a gradual weekly titration based on learnings from Phase 1b. With robust safety and early efficacy signals, and patent protection secured through 2044, Ascletis is gearing up to challenge major players like Novo Nordisk and Eli Lilly in the next generation of anti-obesity therapeutics.