A Study to Learn How Different Amounts of the Study Medicine Danuglipron Are Taken up Into the Blood in Otherwise Healthy Adults With Overweight or Obesity

A PHASE 1, OPEN- LABEL STUDY TO EVALUATE THE MULTIPLE DOSE PHARMACOKINETICS OF DANUGLIPRON FOLLOWING ORAL ADMINISTRATION IN OTHERWISE HEALTHY ADULT PARTICIPANTS WITH OVERWEIGHT OR OBESITY

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06568731

Enrollment

Registered

2024-08-23

Start date

2024-08-23

Completion date

2024-12-18

Last updated

2025-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Overweight, Obesity, Danuglipron, GLP-1, Overtly healthy

Brief summary

The purpose of this study is to learn the following about the study medicine, danuglipron, after multiple days of dosing in healthy adults who are overweight or obese: * how the study medicine, danuglipron, is taken up into the blood * about the safety and tolerability of danuglipron The total number of weeks of the study is about 15 (about 4 months).

Interventions

DRUGDanuglipron

Danuglipron oral tablets

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

Key Inclusion Criteria: * 18 years of age or older * Body mass index (BMI) of ≥25.0-45.4 kg/m2; and a total body weight \>50 kg (110 lb) Key

Exclusion criteria

* Evidence or history of any clinically significant medical conditions or laboratory abnormality * Any condition possibly affecting drug absorption * Known intolerance/hypersensitivity to a GLP-1R agonist

Design outcomes

Primary

Measure	Time frame
Steady-state area under the concentration-time profile from time zero to 24 hours (AUC24) for danuglipron	Predose to 24 hours post danuglipron administration
Steady-state maximum observed concentration (Cmax) for danuglipron	Predose to 24 hours post danuglipron administration
Steady-state time to reach maximum observed concentration (Tmax) for danuglipron	Predose to 24 hours post danuglipron administration

Secondary

Measure	Time frame
Change from baseline in body weight	From baseline up to 28-35 days post last dose taken
Number of participants reporting Treatment Emergent Adverse Events (TEAEs)	From baseline up to 28-35 days post last dose taken
Number of participants reporting clinically significant changes ECG abnormalities	From baseline up to 28-35 days post last dose taken
Number of participants reporting clinically significant clinical laboratory abnormalities	From baseline up to 28-35 days post last dose taken
Number of participants reporting clinically significant vital sign abnormalities	From baseline up to 28-35 days post last dose taken

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026