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Phase I Drug-Drug Interaction Study of UBT251 Injection in Participants With Overweight or Obesity

NCT07785934 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-08-25

No results posted yet for this study

Summary

This is a Phase I, open-label, two-cohort study designed to evaluate the drug-drug interaction potential of multiple-dose UBT251 Injection in adult participants with overweight or obesity.

The primary objective of Cohort 1 is to evaluate the effect of UBT251 Injection on the pharmacokinetic (PK) profiles of metformin and warfarin. The secondary objectives of Cohort 1 are to assess the influence of UBT251 Injection on the pharmacodynamic (PD) characteristics of warfarin, to evaluate the safety of UBT251 Injection administered alone, as well as metformin and warfarin administered alone or in combination with UBT251 Injection, and to characterize the PK, PD, and immunogenicity profiles following repeated UBT251 Injection dosing.

The primary objective of Cohort 2 is to evaluate the effect of UBT251 Injection on the PK profiles of atorvastatin and digoxin. The secondary objectives of Cohort 2 are to evaluate the safety of UBT251 Injection alone, atorvastatin and digoxin alone, and their combination with UBT251 Injection, as well as to assess the PK, PD, and immunogenicity characteristics after multiple administrations of UBT251 Injection.

Conditions

  • Drug Drug Interaction (DDI)
  • Pharmacokinetics and Pharmacodynamics

Interventions

DRUG

UBT251

Subcutaneous injection administered once weekly with dose escalation

DRUG

Metformin hydrochloride

Oral administration. Metformin hydrochloride will be given as twice-daily doses for 7 consecutive administrations.

DRUG

Warfarin Sodium

Oral administration. Warfarin sodium will be given as 2 single doses.

DRUG

Atorvastatin calcium

Oral administration. Atorvastatin calcium will be given as 2 single doses.

DRUG

Digoxin

Oral administration. Digoxin will be given as 2 single doses.

Sponsors & Collaborators

  • The United Bio-Technology (Hengqin) Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-27
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07785934 on ClinicalTrials.gov