Ascletis Secures FDA IND Clearance for Phase II Diabetes Study of Oral GLP-1 ASC30

Ascletis Secures FDA IND Clearance for Phase II Diabetes Study of Oral GLP-1 ASC30

By, Admin 5 January 2026

Ascletis Pharma has received FDA IND clearance to begin a Phase II study of ASC30 in type 2 diabetes. This marks a key expansion of ASC30 beyond obesity into the much larger diabetes market.

Phase II Diabetes Trial: Study Design at a Glance

The upcoming study is a 13-week, randomized, double-blind, placebo-controlled, multi-center trial in the U.S.

Key details:

  • ~100 adults with type 2 diabetes mellitus
  • Enrollment expected to start Q1 2026
  • Once-daily oral ASC30 tablets

Dose allocation:

  • 40 mg, 60 mg, and 80 mg ASC30
  • Matching placebo
  • Randomization ratio: 2:3:3:2

ASC30 will be titrated weekly from 1 mg to target doses.

Primary and Secondary Endpoints

Primary endpoint

  • Mean change in HbA1c from baseline at 13 weeks versus placebo

Secondary endpoints

  • Change in fasting blood glucose
  • Change in body weight
  • Safety and tolerability outcomes

Strong Phase II Obesity Data De-Risk the Program

Ascletis recently completed a 13-week U.S. Phase II study of ASC30 in obesity or overweight. Results were both clinically meaningful and dose-dependent.

Placebo-adjusted weight loss at 13 weeks:

  • 5.4% at 20 mg
  • 7.0% at 40 mg
  • 7.7% at 60 mg

No weight-loss plateau was observed.

Gastrointestinal Tolerability Stands Out

ASC30 showed favorable GI tolerability compared with other oral GLP-1s.

Key safety highlights:

  • Vomiting rate was ~50% lower than published data for orforglipron with weekly titration
  • GI tolerability comparable to orforglipron titrated every four weeks in Phase III
  • No hepatic safety signal
  • Discontinuation due to adverse events: 4.8%

What Makes ASC30 Different?

ASC30 is a small-molecule, fully biased GLP-1 receptor agonist, discovered and developed in-house.

Differentiation points:

  • Once-daily oral dosing
  • Potential for monthly or quarterly subcutaneous dosing
  • Designed for obesity, diabetes, and broader metabolic disease use

Management Commentary

“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’s clinical development into the large diabetes treatment market.”

Why This Matters?

Oral GLP-1s remain one of the most competitive drug classes in pharma.

ASC30’s profile suggests:

  • Competitive weight loss
  • Improved tolerability
  • Flexible dosing potential

If Phase II diabetes data hold up, ASC30 could become a serious contender in metabolic disease therapy.

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