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

Conditions

• Drug Drug Interaction (DDI)
• Pharmacokinetics and Pharmacodynamics

Eligibility Criteria

Sex

ALL

Age

18 Years - 45 Years

Healthy Volunteers

Not accepted

Interventions

• UBT251 — DRUG
  Subcutaneous injection administered once weekly with dose escalation
• Metformin hydrochloride — DRUG
  Oral administration. Metformin hydrochloride will be given as twice-daily doses for 7 consecutive administrations.
• Warfarin Sodium — DRUG
  Oral administration. Warfarin sodium will be given as 2 single doses.
• Atorvastatin calcium — DRUG
  Oral administration. Atorvastatin calcium will be given as 2 single doses.
• Digoxin — DRUG
  Oral administration. Digoxin will be given as 2 single doses.

Study Details

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.

Key Dates

First listed

Aug 25, 2026

Start date

May 27, 2026

Status verified

Aug 2026

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

48 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Arms

• Experimental: UBT251
  This study contains two cohorts. Cohort 1: Participants will first receive multiple-dose metformin, then a single-dose warfarin after a 7-day washout period, with PK/PD sampling for both treatments. Following a 20-week weekly dose-escalation phase of UBT251, metformin will be administered 24 hours after the 5th consecutive fixed-dose UBT251 injection, and warfarin will be given 24 hours after the 6th injection. Dosing and PK/PD sampling procedures will match those of the single-drug phase. Cohort 2: Participants will receive single-dose atorvastatin and digoxin separated by a 7-day washout period, with PK sampling for each drug. After the 20-week UBT251 weekly dose-escalation phase, atorvastatin will be given 24 hours after the 5th consecutive fixed-dose UBT251 injection, and digoxin will be administered 24 hours after the 6th injection. PK sampling procedures will be consistent with those of the single-drug treatment phase.

Primary Outcome Measure

Area under plasma concentration-time curve of metformin (AUC0-τ) and S-warfarin, R-warfarin (AUC0-t, AUC0-∞) [ Time Frame: From time 0 to 30 hours (metformin, post last dose) and 168 hours (S-warfarin, R-warfarin) after respective doses ]

Central Contacts

• Wei Hu, PhD
  +86-13856086475
  [email protected]