Ascletis Secures FDA IND Clearance for Oral GLP-1 ASC30 in Type 2 Diabetes

Ascletis Pharma has received US FDA Investigational New Drug (IND) clearance to advance ASC30, its oral small-molecule GLP-1 receptor agonist, into a Phase II diabetes study.

This marks ASC30’s formal entry into the type 2 diabetes (T2D) clinical pathway.

Phase II Study: What to Know

The upcoming Phase II trial is designed to test ASC30 in adults with T2D.

Study design

• 13-week, randomized, double-blind, placebo-controlled
• Multi-centre trial across the United States
• ~100 participants with type 2 diabetes

Dose arms

• ASC30 tablets: 40 mg, 60 mg, 80 mg
• Matching placebo
• Randomization ratio: 2:3:3:2
• Weekly titration from 1 mg to target dose

Timeline

• Enrollment expected to begin Q1 2026

Primary and Secondary Endpoints

Primary endpoint

• Mean change from baseline in HbA1c at 13 weeks

Key secondary endpoints

• Fasting blood glucose reduction
• Change in body weight
• Safety and tolerability

Why This Matters: Strong Obesity Phase II Data?

The diabetes study builds on recently completed 13-week Phase II obesity data for ASC30.

Key obesity trial results

• 125 participants with obesity or overweight
• Once-daily oral dosing
• Statistically significant, dose-dependent weight loss

Placebo-adjusted mean weight loss

• 20 mg: 5.4%
• 40 mg: 7.0%
• 60 mg: 7.7%
• No weight-loss plateau observed

Tolerability highlights

• Vomiting rate ~50% lower than published orforglipron data
• GI tolerability comparable to orforglipron Phase III ATTAIN-1
• Treatment discontinuation due to AEs: 4.8%

What Makes ASC30 Different?

ASC30 is not another injectable GLP-1. It is:

• A small-molecule GLP-1R agonist
• Fully biased agonist
• Designed for once-daily oral dosing
• Also suitable for monthly to quarterly subcutaneous dosing

This flexibility positions ASC30 for both treatment and maintenance therapy.

Leadership Perspective

“IND clearance for this Phase II diabetes study is a significant milestone,” said Dr. Jinzi Jason Wu, Founder and CEO of Ascletis.

The FDA clearance expands ASC30 into the large and competitive diabetes market, strengthening its commercial potential.

Ascletis’ Broader Metabolic Pipeline

Ascletis is building a diversified metabolic portfolio using in-house platforms. Key assets include:

• ASC30: Oral GLP-1R agonist
• ASC36: Once-monthly amylin receptor peptide agonist
• ASC35: Monthly GLP-1R/GIPR dual agonist
• ASC37: Oral GLP-1R/GIPR/GCGR triple agonist

All programs are developed using proprietary AI-driven drug discovery and long-acting delivery technologies.

Bottom Line

ASC30 now sits at the intersection of:

• Oral GLP-1 convenience
• Strong early efficacy
• Competitive GI tolerability
• Expansion into diabetes after obesity success

If Phase II diabetes data mirrors obesity results, ASC30 could become a serious oral GLP-1 contender.

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