A phase 1 single and multiple ascending dose study of orforglipron in Japanese participants with type 2 diabetes.

ABSTRACT:

Introduction

We aimed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of orforglipron in Japanese participants with type 2 diabetes.

Materials and methods

This was a double-blind, placebo-controlled, randomized, phase 1 study. In Part A, participants received single doses of orforglipron (2 or 3 mg) or placebo. In Part B, participants received multiple ascending doses of daily oral orforglipron (final target doses: 12, 24, and 45 mg) or placebo for 12 weeks.

Results

Parts A and B enrolled 23 and 60 participants, respectively. The most common treatment-emergent adverse events were gastrointestinal events of mild severity. No severe or serious adverse events were reported. At week 12, median t_max was 5

SUBMITTER: Ohwaki K 

PROVIDER: S-EPMC12863000 | biostudies-literature | 2026 Feb

REPOSITORIES: biostudies-literature