First‐in‐human study of HDM1002 , a GLP ‐1 receptor agonist: Safety, tolerability, pharmacokinetics and pharmacodynamics of escalating single oral doses in healthy volunteers

Jul 15, 2025Diabetes, obesity & metabolism

Initial human study of HDM1002, a drug activating GLP-1 receptors: safety, side effects, and how the body processes single increasing oral doses in healthy people

AI simplified

GLP-1 Therapies on OpenScience ↗PubMed ↗DOI ↗

Abstract

A total of 79 participants completed the study, with no serious adverse events reported.

The most common adverse events included nausea, diarrhea, vomiting, and decreased appetite, increasing with higher doses.
Pharmacokinetics of HDM1002 appeared to be dose-proportional from 10 to 600 mg.
The time to reach peak concentration ranged from 4.99 to 7.10 hours.
Similar levels of HDM1002 were observed under both fed and fasted conditions.
HDM1002 significantly lowered postprandial glucose levels in a dose-dependent manner and maintained this effect at 6 and 12 hours for doses between 100-600 mg.

AI simplified

AIMS: To evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single oral doses of HDM1002 in healthy adult participants.

MATERIALS AND METHODS: This was a first-in-human, randomized, double-blind, placebo-controlled, 2-part study. Healthy participants aged 18 to 55 years with a body mass index (BMI) of 19.0 ~ 32.0 kg/mwere eligible. In the single ascending dose (SAD) part, eligible participants were randomized (8:2) to receive a single oral escalating dose of HDM1002 (10-600 mg) or placebo. In the food effect (FE) part, participants were randomized (7:7) to receive HDM1002 (200 mg) in the fasted and fed states with a two-period, crossover design. 2

RESULTS: A total of 79 participants enrolled and completed the study. The most common adverse events (AEs) were nausea, diarrhoea, vomiting and decreased appetite, which increased in a dose-dependent manner. No serious AEs were reported. Cand AUC appeared to be dose-proportional from 10 to 600 mg by a power model. The geometric mean tranged from 4.99 to 7.10 h. Cand AUC of HDM1002 were similar under fed and fasted conditions. HDM1002 significantly lowered postprandial glucose in a dose-dependent manner and maintained the glucose-lowering effect at both 6 and 12 h at 100-600 mg doses. max1/2z max

CONCLUSIONS: HDM1002 was safe and well tolerated at 10-600 mg. HDM1002 showed linear pharmacokinetics, and a standardized high-fat meal did not impact systemic exposure. These results provide preliminary evidence supporting further clinical development of HDM1002 in individuals with type 2 diabetes.

Full Text

Full text is available at the source.

View full text (PDF) ↗View full text (XML) ↗View full text ↗

First‐in‐human study of HDM1002 , a GLP ‐1 receptor agonist: Safety, tolerability, pharmacokinetics and pharmacodynamics of escalating single oral doses in healthy volunteers

Abstract

Full Text

You found one interesting study. We’ll send the next 7.

what lands in your inbox each week:

Recent issues from the glp-1 therapies brief

Abstract

Full Text

Related papers

You found one interesting study. We’ll send the next 7.

what lands in your inbox each week:

Recent issues from the glp-1 therapies brief