Ascletis Receives FDA Clearance to Begin Phase I Study of Once-Monthly Obesity Drug ASC35

Ascletis Advances New Obesity Treatment Candidate Into Clinical Development

Ascletis Pharma has announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for ASC35, a next-generation obesity treatment candidate.
The approval allows the company to begin a Phase I clinical trial in the United States for ASC35, a once-monthly injectable therapy designed to target both GLP-1 and GIP receptors. These receptors play an important role in regulating appetite, body weight, and metabolism.
The company believes ASC35 has the potential to become a best-in-class treatment in the rapidly growing obesity market.

Phase I Trial Will Evaluate Safety and Early Effectiveness

The upcoming Phase I study is a randomized, double-blind, placebo-controlled trial involving 84 participants.
The study will enroll adults living with obesity, defined as a body mass index (BMI) of 30 kg/m² or higher, as well as overweight individuals with weight-related health conditions.
Researchers will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ASC35 through both single and multiple dose testing.
The clinical trial is divided into two sections.
Part A will evaluate single ascending doses of ASC35 using the company's once-monthly Self-Assembling Lipid Depot (SALD) formulation.
Part B will compare multiple ascending doses of ASC35 directly against tirzepatide, the widely used once-weekly obesity treatment currently approved by the FDA.
This head-to-head comparison is expected to provide an early indication of how ASC35 performs against one of the leading therapies in the obesity market.

Designed for Once-Monthly Administration

One of the key features of ASC35 is its once-monthly dosing schedule.
The treatment uses Ascletis' proprietary Self-Assembling Lipid Depot technology, which is designed to slowly release the active drug over an extended period after injection.
The formulation starts as a low-viscosity liquid that can be administered using a standard injection pen or auto-injector with a fine needle. Once injected under the skin, the solution forms a gel-like depot that gradually breaks down and releases the medicine over a month or longer.
The company believes this approach could improve convenience for patients compared to weekly injections currently available in the market.

Preclinical Studies Show Encouraging Results

Ascletis highlighted several preclinical findings that support the advancement of ASC35 into human trials.
In head-to-head non-human primate studies, ASC35 demonstrated an average observed half-life that was approximately six times longer than tirzepatide. According to the company, this longer half-life supports the possibility of effective once-monthly dosing in humans.
Researchers also observed a flatter pharmacokinetic profile with ASC35. This may potentially translate into improved gastrointestinal tolerability, although this will need to be confirmed in clinical studies.
The company also reported that drug exposure levels following both intravenous and subcutaneous administration were higher for ASC35 compared to tirzepatide in animal studies.

Mouse Study Demonstrated Greater Weight Reduction

Additional data from a diet-induced obese mouse study showed promising weight-loss results.
When tested at equal molar concentrations, ASC35 delivered approximately 71% greater relative body weight reduction compared with tirzepatide.
Ascletis also reported that ASC35 demonstrated approximately four times greater potency than tirzepatide when targeting both GLP-1 and GIP receptors in laboratory testing.
Based on these findings, the company believes ASC35 may provide greater efficiency on a per-milligram basis compared with existing therapies.

Technology Platforms Behind ASC35

ASC35 was discovered and developed internally by Ascletis using its Artificial Intelligence-Assisted Structure-Based Drug Discovery technology.
The company also utilized its Ultra-Long-Acting Platform technology to create the once-monthly SALD formulation.
Ascletis has been building a broader metabolic disease pipeline using these technology platforms, with several obesity-focused drug candidates currently in development.
These include ASC30, ASC36, ASC37, ASC39, and a fixed-dose combination program known as ASC30_39, all targeting chronic weight management through different biological pathways.

Company Sees Opportunity in Growing Obesity Market

Commenting on the FDA clearance, Dr. Jinzi Jason Wu, Founder, Chairman and CEO of Ascletis, described the milestone as an important step forward for the company’s obesity pipeline.
According to Wu, ASC35’s combination of potentially stronger weight-loss efficacy and a more convenient once-monthly injection schedule could address a significant unmet need among patients seeking long-term obesity treatment options.
With regulatory clearance now secured, Ascletis will move forward with clinical testing as it works to validate the promising preclinical data generated so far and determine the therapy’s potential role in the future obesity treatment landscape.

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