Neurocrine Biosciences has launched a Phase 1 first-in-human trial of NBIP-‘1968, a once-weekly GLP-1/GIP/glucagon receptor triple agonist being developed as a novel treatment for obesity.
Written By: Farha Farheen, PharmD
Reviewed By: Pharmacally Editorial Team
Neurocrine Biosciences has started dosing participants in a Phase 1 first-in-human clinical study evaluating NBIP-‘1968, an investigational long-acting GLP-1/GIP/glucagon receptor triple agonist for obesity. The trial will assess the safety and tolerability of single ascending doses in adults across a range of body mass index (BMI) categories, including individuals who are overweight or living with obesity.
The study represents an important clinical milestone for the company’s growing obesity portfolio as competition intensifies in the next generation of incretin-based therapies. Unlike dual agonists, NBIP-‘1968 simultaneously targets three metabolic receptors involved in appetite regulation, energy expenditure, and glucose homeostasis.
Triple Agonist Targets Complementary Metabolic Pathways
NBIP-‘1968 is an internally discovered investigational therapy developed for once-weekly subcutaneous administration. The molecule activates glucagon-like peptide-1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP), and glucagon receptors to influence several biological pathways that regulate body weight and metabolism.
According to the company, the candidate incorporates balanced glucagon receptor activity intended to maximize the metabolic benefits associated with glucagon signaling while maintaining an acceptable tolerability profile. Triple agonists are being explored as a potential strategy to achieve greater weight reduction, improve glycemic control, and increase energy expenditure compared with therapies targeting fewer receptors.
Obesity remains a major global health challenge and substantially increases the risk of type 2 diabetes, cardiovascular disease, obstructive sleep apnea, metabolic dysfunction-associated steatotic liver disease (MASLD), certain cancers, and osteoarthritis. Although GLP-1-based medicines have transformed obesity management, limitations including gastrointestinal adverse effects, dose escalation requirements, and concerns about lean muscle loss continue to drive the search for additional treatment options.
Phase 1 Study Focuses on Safety and Tolerability
The first-in-human Phase 1 trial will evaluate single ascending doses of NBIP-‘1968 in adult participants representing multiple BMI categories. The primary objective is to characterize the investigational therapy’s safety and tolerability before advancing to later-stage clinical development.
No efficacy data are available at this stage, as the initial study is intended to establish an acceptable safety profile and support dose selection for future clinical trials.
Executives Highlight Broader Obesity Development Strategy
Chief Medical Officer Sanjay Keswani, M.D., said obesity involves multiple biological pathways, creating a need for therapies that act through complementary mechanisms. He noted that NBIP-‘1968 reflects the company’s strategy of investigating multiple scientific approaches to obesity treatment.
Chief Scientific Officer Jude Onyia, Ph.D., added that advancing the candidate into clinical testing strengthens Neurocrine’s obesity research program, which is exploring differentiated mechanisms that may improve weight loss while preserving lean body mass.
Combination Development Planned
NBIP-‘1968 forms part of Neurocrine’s broader obesity pipeline, which also includes NBIP-‘2118, an investigational corticotropin-releasing factor type 2 (CRF2) receptor agonist currently in Phase 1 development. The company intends to evaluate NBIP-‘1968 as part of a fixed-dose combination with NBIP-‘2118, while continuing to advance additional early-stage obesity programs investigating complementary mechanisms and extended dosing intervals.
Successful completion of the ongoing Phase 1 study will provide the first clinical evidence supporting the safety of NBIP-‘1968 and inform subsequent multiple-dose studies as Neurocrine expands its clinical development strategy in the increasingly competitive obesity therapeutics landscape.
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About the Writer
Farha Farheen, PharmD (LinkedIn) is a pharmacy professional with a strong interest in pharmacovigilance and clinical research. She has completed her Doctor of Pharmacy (Pharm.D) along with her internship as a Clinical Pharmacist. She has hands-on experience in adverse drug reaction (ADR) reporting, safety data documentation, and pharmacovigilance workflows, and is proficient in using VigiFlow. She is also a patent holder for an antibacterial formulation enriched with bioactive substances, granted by the German Patent and Trademark Office.