New Oral GLP-1 Drug HDM1002 Passes First Human Safety Test | Research

The takeaway

First-in-human study of HDM1002, a novel oral GLP-1 agonist, showed acceptable safety and expected GI side effects in 79 healthy volunteers.

79 participants
First-in-human safety study of oral GLP-1 agonist HDM1002 at doses up to 600 mg

What the researchers found

HDM1002 was tolerable at doses up to 600 mg in healthy volunteers with predictable GLP-1 class side effects.

Why it matters

The race for convenient oral GLP-1 drugs continues — HDM1002 adds another candidate to the pipeline beyond oral semaglutide and orforglipron.

The numbers in context

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 the study worked

First-in-human, randomized, double-blind, placebo-controlled, 2-part study (SAD + food effect) in 79 healthy participants.

Who was studied

Healthy adults aged 18-55 with BMI 19-32

What this study cannot tell us

First-in-human single-dose study — efficacy, chronic dosing safety, and metabolic outcomes not yet assessed.

How to read the evidence

Phase 1 first-in-human study — appropriate for safety/PK assessment but no efficacy data yet.

When this study was published

Published in 2025, adding to the rapidly expanding oral GLP-1 drug development pipeline.

The bigger picture

Competition in the oral GLP-1 space will ultimately benefit patients through better options, lower costs, and improved convenience.

Questions still open

How does HDM1002 bioavailability compare to oral semaglutide and orforglipron?
What dose will move forward to Phase 2 efficacy trials?

Common 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 the original research

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

View on PubMed ↗Publisher’s paper ↗

Citation

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