Cully Pharmaceutical-B (01672) launches two Phase I studies to treat obesity in the US

Zhitong Financial App News, Goli Pharmaceutical-B (01672) announced that after receiving approval from the US Food and Drug Administration (FDA) New Drug Clinical Trial Application (IND), it has initiated two Phase I studies to treat obesity in the US: monthly to quarterly new-generation pancreatic agonist polypeptide ASC36, and ASC36 and GLP-1R/GIPR dual-target agonist polypeptide ASC36_35FDC monthly injections ASC36_35FDC.

This phase I study of ASC36_35FDC is a randomized, double-blind, placebo-controlled trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ASC36_35FDC injections in obese (body mass index (BMI) ≥30.0 kg/m²) or overweight (BMI ≥27.0 kg/m²) subjects with weight-related complications. The Phase I study will also evaluate two different fixed-dose combination (FDC) formulations: injection A in 88 subjects and injection B in 88 subjects. Both injections A and B are composed of two ultra-long-acting agonist polypeptides: the amygdalin agonist polypeptide ASC36 and the GLP-1R/GIPR dual-target agonist polypeptide ASC35.

This phase I trial of ASC36 is a randomized, double-blind, placebo-controlled clinical trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacokinetics of ASC36 injections after single dose and multiple dose escalation in obese (BMI ≥30.0 kg/m²) or overweight (BMI ≥27.0 kg/m²) subjects with weight-related complications. The Phase I study will also evaluate two different formulations: injection A in 72 subjects and injection B in 72 subjects.

“Recent data from Eloralintide in combination with tirpotide showed a weight loss of 29.0% at week 32. However, this program requires two injections per week, one dose of eloralintide and the other dose of tirpotide. This is equivalent to eight injections per month. In contrast, ASC36_35FDC is expected to be the first of its kind to target insulin receptors, GLP-1R, and GIPR, a subcutaneous fixed-dose compound injection, requiring only one injection per month. What is even more exciting is that in the head-to-head diet induced obesity (DIO) rat study, the weight loss effect of ASC36_35FDC was relatively increased by about 51% compared to eloralintide combined with terpotide (see our announcement dated November 13, 2025 for more information). These animal models are highly predictive of human efficacy.” Dr. Wu Jinzi, founder, chairman of the board of directors and CEO of Geli, said, “As we launch the GLP-1 oral small molecule ASC30 global phase III clinical program, I am also delighted with the significant progress we have made in 2026 on the monthly subcutaneous peptide pipeline. These developments are reflected in our launch of three Phase I studies in the US: ASC35, ASC36, and ASC36_35FDC.”

Both ASC36 and ASC35 were independently developed by Goli using its structure-based AI-assisted drug discovery (AISBDD) technology. The ASC36 monthly to quarterly formulations and the ASC36_35FDC monthly compound formulations are self-assembled lipid storage type (SALD) formulations, independently developed by Gely using its proprietary Ultra Long-acting Drug Development Platform (ULAP) technology.

SALD is a low viscosity solution composed of lipids, biocompatible organic solvents, and active pharmaceutical ingredients (APIs). The low viscosity solution can be easily injected into the subcutaneous tissue using an injection pen or autoinjector with a fine 29G (gauge) needle. After subcutaneous injection, the solution is converted into a gel-like depot (depot) in the tissue. Under the influence of enzymes in the tissue, this reservoir slowly degrades, thereby controlling the continuous release of the API for a month or more.

In head-to-head non-human primate studies, the ASC36 SALD formulation had an apparent half-life (half-life) of about 6 times that of eloralintide, supporting subcutaneous administration once a month to once a quarter in humans. In non-human primate studies, both ASC36 and ASC35 showed long apparent half-lives in the ASC36_35FDC SALD compound, supporting monthly subcutaneous administration in humans.

Preclinical studies have established the superior efficacy of ASC36 injections and ASC36_35FDC compound injections. In a head-to-head DIO rat study (which is highly predictive of efficacy in humans), the weight loss effect of ASC36 single drug targeting the insulin receptor was about 91% and 32% higher compared to petrelintide alone and eloralintide alone, respectively. In a head-to-head DIO rat study, ASC36_35FDC targeted the three targets of amylin receptor, GLP-1R, and GIPR, and the weight loss effect was relatively increased by about 51% compared to eloralintide combined with telpotide.

Both ASC36 injection and ASC36_35FDC compound injection have excellent physico-chemical stability, and there is no agglomeration caused by fibrosis near the neutral pH value.