Regulatory toxicology and pharmacology : RTPJul 30, 2026

40-week safety, body processing, and immune response to repeated doses of efsubaglutide alfa under the skin in monkeys

GLP-1 Therapies Weekly Brief ↗PubMed ↗DOI ↗

Updated Aug 3, 2026

Abstract

No deaths or treatment-related systemic organ toxicities were observed in cynomolgus monkeys administered efsubaglutide alfa.

Reduced food intake and decreased body weight gain were noted early during dosing, likely due to the drug's pharmacological effects.
Reversible, dose-related inflammation at injection sites was the primary microscopic finding.
Systemic exposure to efsubaglutide alfa increased with dose but remained stable over time without significant accumulation.
Anti-drug antibodies were detected at a low incidence and did not lead to clinically meaningful changes in safety or drug exposure.
The highest dose tested, 3 mg/kg, was determined to be the no observed adverse effect level (NOAEL) for this study.

Simplified

Efsubaglutide alfa is a novel humanized long-acting glucagon-like peptide-1 receptor agonist (GLP-1RA) developed for the treatment of type 2 diabetes and other metabolic diseases. To support chronic clinical use, we evaluated the systemic safety, toxicokinetics (TK), and immunogenicity of efsubaglutide alfa in cynomolgus monkeys. Twenty males and twenty females were randomized to receive vehicle control or efsubaglutide alfa (0.3, 1, or 3 mg/kg) by subcutaneous injection twice weekly for 40 weeks, followed by an 8-week recovery period. Endpoints included clinical observations, food intake, body weight, electrocardiography, hematology, clinical chemistry, urinalysis, immunotoxicity, anti-drug antibodies, TK, and full macroscopic and microscopic pathology. There were no deaths and no treatment-related systemic organ toxicities. Reduced food intake and attenuated body weight gain occurred early during dosing and were considered pharmacology-related. The primary microscopic finding was reversible, dose-related inflammation at injection sites. Systemic exposure increased with dose and remained broadly stable over time, with no evidence of marked accumulation. Anti-drug antibodies occurred at low incidence and were not associated with clinically meaningful changes in safety parameters or TK. The NOAEL was 3 mg/kg under the conditions of this study, supporting further clinical development of efsubaglutide alfa.

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Competing interests

Declaration of Competing Interest Qinghua Wang is the founder of Innogen Pharmaceutical Co., Ltd. Yuyang Lei, Liping Chen, and Guirui Yan are employees of Innogen Pharmaceutical Co., Ltd. The remaining authors declare no competing interests.

PubMed

40-week safety, body processing, and immune response to repeated doses of efsubaglutide alfa under the skin in monkeys

Abstract

Full Text

Funding

Competing interests

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