New Oral GLP-1 Drug HDM1002 Passes First Human Safety Test
First-in-human study of HDM1002, a novel oral GLP-1 agonist, showed acceptable safety and expected GI side effects in 79 healthy volunteers.
Quick Facts
What This Study Found
HDM1002 was tolerable at doses up to 600 mg in healthy volunteers with predictable GLP-1 class side effects.
Key Numbers
N=79; doses 10-600 mg; t1/2 4.99-7.10 hours; dose-proportional Cmax and AUC; no food effect; no serious AEs.
How They Did This
First-in-human, randomized, double-blind, placebo-controlled, 2-part study (SAD + food effect) in 79 healthy participants.
Why This Research Matters
The race for convenient oral GLP-1 drugs continues — HDM1002 adds another candidate to the pipeline beyond oral semaglutide and orforglipron.
The Bigger Picture
Competition in the oral GLP-1 space will ultimately benefit patients through better options, lower costs, and improved convenience.
What This Study Doesn't Tell Us
First-in-human single-dose study — efficacy, chronic dosing safety, and metabolic outcomes not yet assessed.
Questions This Raises
- ?How does HDM1002 bioavailability compare to oral semaglutide and orforglipron?
- ?What dose will move forward to Phase 2 efficacy trials?
Trust & Context
- Key Stat:
- 79 participants First-in-human safety study of oral GLP-1 agonist HDM1002 at doses up to 600 mg
- Evidence Grade:
- Phase 1 first-in-human study — appropriate for safety/PK assessment but no efficacy data yet.
- Study Age:
- Published in 2025, adding to the rapidly expanding oral GLP-1 drug development pipeline.
- Original Title:
- First-in-human study of HDM1002, a GLP-1 receptor agonist: Safety, tolerability, pharmacokinetics and pharmacodynamics of escalating single oral doses in healthy volunteers.
- Published In:
- Diabetes, obesity & metabolism, 27(10), 5622-5631 (2025)
- Authors:
- Pu, Junliang, Huang, Yurui, Wan, Lei(2), Zhu, Mingxue, Wei, Huili, Gao, Hong, Zhong, Liping, Tang, Chengyong, Xu, Junfang
- Database ID:
- RPEP-13120
Evidence Hierarchy
Frequently Asked Questions
What is HDM1002?
A new oral GLP-1 drug being developed for diabetes and obesity — this was its first test in humans, showing it is safe at doses up to 600 mg.
How many oral GLP-1 drugs are being developed?
Several, including oral semaglutide (approved), orforglipron (Phase 3), and HDM1002 (Phase 1) — competition is driving innovation.
Read More on RethinkPeptides
Cite This Study
https://rethinkpeptides.com/research/RPEP-13120APA
Pu, Junliang; Huang, Yurui; Wan, Lei; Zhu, Mingxue; Wei, Huili; Gao, Hong; Zhong, Liping; Tang, Chengyong; Xu, Junfang. (2025). First-in-human study of HDM1002, a GLP-1 receptor agonist: Safety, tolerability, pharmacokinetics and pharmacodynamics of escalating single oral doses in healthy volunteers.. Diabetes, obesity & metabolism, 27(10), 5622-5631. https://doi.org/10.1111/dom.16610
MLA
Pu, Junliang, et al. "First-in-human study of HDM1002, a GLP-1 receptor agonist: Safety, tolerability, pharmacokinetics and pharmacodynamics of escalating single oral doses in healthy volunteers.." Diabetes, 2025. https://doi.org/10.1111/dom.16610
RethinkPeptides
RethinkPeptides Research Database. "First-in-human study of HDM1002, a GLP-1 receptor agonist: S..." RPEP-13120. Retrieved from https://rethinkpeptides.com/research/pu-2025-firstinhuman-study-of-hdm1002
Access the Original Study
Study data sourced from PubMed, a service of the U.S. National Library of Medicine, National Institutes of Health.
This study breakdown was produced by the RethinkPeptides research team. We analyze and report published research findings without making health recommendations. All interpretations are based solely on the published abstract and study data.