Celltrion said on May 29 that it has entered the final stage of preclinical development for global clinical trials of its next-generation obesity treatment candidate CT-G32 by launching primate toxicology studies. The company aims to submit an investigational new drug (IND) application in the first half of next year.
CT-G32 is a next-generation obesity therapy designed to simultaneously target four pathways, including GLP-1. Celltrion is developing the candidate as a potential first-in-class drug.
The company said the treatment is intended to address limitations associated with existing GLP-1-based obesity therapies, including variability in patient weight-loss responses, muscle loss, and durability issues, while maximizing weight reduction effects.
Celltrion added that it plans to develop CT-G32 not simply as a weight-loss drug, but as a metabolic disease platform therapy capable of regulating fat, muscle, and overall energy metabolism.
The toxicology study will evaluate the safety and toxicity profile of CT-G32 in 252 rats and 48 monkeys. The study is considered a key step in determining appropriate dosing levels and establishing safety parameters for future clinical trials. Celltrion also plans to further assess the candidate’s pharmacokinetic (PK) and pharmacodynamic (PD) characteristics alongside the toxicology evaluation.
In earlier nonclinical studies, CT-G32 demonstrated superior weight-loss effects at equivalent doses compared with benchmark drugs under development, while also preserving lean body mass (LBM), the company said.
Lean body mass refers to body weight excluding fat, including muscles, bones, and organs. In obesity drug development, maintaining muscle mass alongside weight reduction is considered a key evaluation metric.
Based on the preclinical data, Celltrion plans to file the IND application in the first half of next year and move ahead with global clinical development. The company is also reviewing potential expansion into metabolic disease indications including diabetes and metabolic dysfunction-associated steatohepatitis (MASH).
In parallel, Celltrion is also developing a multi-action oral obesity treatment. The company is conducting studies to improve stability and bioavailability, targeting an IND submission in the second half of 2028.
A Celltrion official said CT-G32 is being developed as a next-generation therapy that overcomes the limitations of existing GLP-1-based treatments while extending beyond obesity into broader metabolic diseases.
The official added that the company plans to continue expanding new drug pipelines in areas including obesity treatments and antibody-drug conjugates (ADCs) to strengthen long-term growth drivers.