ASC30 Monthly Injection Shows Promising Weight Loss Results in Phase II Study

The race to develop next-generation obesity treatments continues to accelerate. A new investigational drug, ASC30, may offer a major advantage: once-monthly injections with -lasting weight loss effects.

Recently, Ascletis Pharma Inc. announced positive topline results from a Phase II clinical trial in the United States evaluating its subcutaneous depot formulation of ASC30 for obesity.

The results suggest that the drug could potentially support monthly treatment dosing and quarterly maintenance therapy, a significant shift from the weekly injections common in current GLP-1 therapies.

Phase II Study Overview

The 24-week randomized, double-blind, placebo-controlled study evaluated the safety and efficacy of ASC30 in 65 participants.

Participants included adults who were:

• Obese (BMI ≥ 30 kg/m²)
• Overweight (BMI ≥ 27 kg/m²) with at least one weight-related comorbidity

Patients received three once-monthly injections of ASC30 or placebo at:

• Day 1
• Day 29 (Week 4)
• Day 57 (Week 8)

Unlike many GLP-1 therapies, the regimen did not require weekly lead-in doses. The study evaluated two subcutaneous depot formulations:

• A1 formulation
• A2 formulation

Among the two, formulation A1 delivered therapeutic drug exposure, while A2 did not.

Significant Weight Loss Achieved

The study met its primary endpoint. Patients treated with ASC30 formulation A1 experienced statistically significant and clinically meaningful weight loss compared with placebo.

Placebo-Adjusted Mean Weight Loss

The 7.5% placebo-adjusted weight loss at week 16 occurred after just three monthly injections.

This level of efficacy is consistent with outcomes typically seen in the GLP-1 receptor agonists category.

Potential for Quarterly Maintenance Therapy

One of the most notable findings was how long the drug’s effects lasted.

After the third and final dose at week 8, participants entered a 16-week maintenance observation period. Weight loss remained largely stable during this time.

Weight Loss After Final Dose

• Week 20: 6.4% placebo-adjusted weight loss
• Week 24: 5.8% placebo-adjusted weight loss

These results suggest the drug could potentially support once-quarterly maintenance dosing.

Safety and Tolerability Results

ASC30 demonstrated a safety profile consistent with GLP-1 drugs.

Key safety observations included:

• No treatment discontinuations due to adverse events
• All adverse events were mild to moderate
• Gastrointestinal events were mild (Grade 1)
• No liver safety signals observed
• No abnormal findings in:
  • Laboratory tests
  • Vital signs
  • ECG readings
  • Physical exams

Injection site reactions were also mild. Overall, the therapy appeared well tolerated by study participants.

A New Type of GLP-1 Drug

ASC30 is not a peptide like many GLP-1 drugs. Instead, it is a small-molecule GLP-1 receptor biased agonist. This design offers a rare advantage: multiple delivery formats for the same molecule. ASC30 has been developed to support:

• Once-daily oral tablets
• Once-monthly subcutaneous injections
• Potential once-quarterly maintenance injections

The molecule was discovered and developed internally by Ascletis Pharma Inc.. It is classified as a new chemical entity (NCE) with global patent protection through 2044.

Technology Behind the Drug

The long-acting formulation relies on Ascletis’ proprietary Ultra-Long-Acting Platform (ULAP).

This technology is designed to enable extended dosing intervals, potentially ranging from monthly to quarterly injections for chronic conditions.

The company also uses AI-assisted structure-based drug discovery to identify and optimize drug candidates.

What This Means for Obesity Treatment?

Most GLP-1 therapies today require weekly injections. A drug that maintains effectiveness with monthly or quarterly dosing could significantly improve treatment adherence.

If future trials confirm these results, ASC30 could represent a more convenient long-term treatment option for chronic weight management.

The next stages of clinical development will determine whether this early promise translates into a new therapy for patients living with obesity.

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