First Participant Dosed in First-in-Human Phase 1 Study of GZC8072, a Novel Ultra-Long-Acting Once-Weekly Oral Peptide GLP-1 RA

BEIJING and BRIDGEWATER, Mass., Sept. 9, 2026 /PRNewswire/ -- Gan&Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as Gan&Lee) announced that the first participant has been dosed in a First-In-Human (FIH) Phase 1 study of GZC8072 tablets, a novel ultra-long-acting oral peptide GLP-1 RA formulated for once-weekly administration. This milestone marks the formal entry of this innovative candidate into clinical development.

The study is a multicenter, randomized, double-blind, parallel-group, placebo-controlled Phase 1 study (CTR20263271), designed to evaluate the safety and tolerability of GZC8072 in healthy adult participants in the single ascending dose (SAD) portion and in participants with overweight or obesity in the multiple ascending dose (MAD) portion. A total of 112 participants are planned for enrollment, and will receive either GZC8072 tablets or matching placebo.

About GZC8072 Tablets

GZC8072 is a novel ultra-long-acting oral peptide GLP-1 RA independently developed by Gan&Lee based on native GLP-1 and designed for once-weekly administration. It is being developed for the treatment of type 2 diabetes mellitus (T2DM) and for weight management in people with obesity or overweight. GZC8072 is underpinned by two proprietary technology platforms — NovaPeptide™, designed to address the challenges of long‑acting peptide development and manufacturing, and SupOraTide™, designed to overcome key barriers to oral peptide delivery. The combined use of these platforms enables GZC8072 to achieve enhanced intrinsic activity, a prolonged pharmacokinetic half‑life, and significantly improved oral bioavailability, supporting a convenient once‑weekly oral dosing regimen. Currently, the global development program for GZC8072 tablets has progressed into Phase 1 clinical studies, with intended therapeutic indications covering T2DM and weight management in patients with obesity or overweight.

Addressing Global Weight Management Needs with Oral Long-Acting Peptide Therapies

Obesity is a chronic disease associated with a broad range of comorbidities and has become a major public health crisis worldwide. According to the World Health Organization, approximately 2.5 billion adults were overweight in 2022^[1], and projections indicate this number will exceed 2.9 billion by 2030^[2]. In this context, extending the duration of action and improving dosing convenience have become important areas of innovation in metabolic disease R&D. The treatment landscape is rapidly evolving - from long‑acting injectables to once-weekly oral formulations - reflecting the demand for patient‑centric options.

From Long-Acting Injectables to Once-Weekly Oral Formulations: Expanding Innovative Therapies

Gan&Lee, with extensive expertise in metabolic disorders, continues to advance its pipeline with a focus on long-acting therapies and greater dosing convenience. Its product portfolio continues to expand, including biweekly injectable bofanglutide (GZR18), ultra-long-acting weekly Insulin Ludefen (GZR4), and GZC8072 tablets — a once-weekly oral formulation that has now entered clinical development.

The clinical initiation of GZC8072 marks a key milestone for the company's weight management franchise. Moving forward, the company will continue to develop more convenient therapeutic regimens leveraging its proprietary technology platforms to expand treatment options for patients.

References:

1. https://www.who.int/zh/news-room/fact-sheets/detail/obesity-and-overweight%5C#1

2. https://slim.medsci.cn/news/detail/be3e8660134f