This is a registry record, not a result. A trial being listed, recruiting or completed says nothing by itself about whether the compound works or is safe.
| Registry number | NCT07785934 |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | The United Bio-Technology (Hengqin) Co., Ltd. |
| Enrollment | 48 participants |
| Design | Interventional, Na, Single Group, Masking: None |
| Conditions | Drug Drug Interaction (DDI); Pharmacokinetics and Pharmacodynamics |
| Interventions | UBT251; Metformin hydrochloride; Warfarin Sodium; Atorvastatin calcium; Digoxin |
| Start | May 27, 2026 |
| Primary completion | Dec 2026 |
| Study completion | Dec 2026 |
| Results posted | Not yet |
| Registry last updated | Aug 25, 2026 |
Compounds on this site that cite this trial
What the registry says the trial is about
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.
Primary outcomes
These are what the trial was designed to measure first. They are registered in advance, which is what makes a later result checkable.
| Outcome measure | Time frame |
|---|---|
| Area under plasma concentration-time curve of metformin (AUC0-u03c4) and S-warfarin, R-warfarin (AUC0-t, AUC0-u221e) | From time 0 to 30 hours (metformin, post last dose) and 168 hours (S-warfarin, R-warfarin) after respective doses |
| Area under plasma concentration-time curve (AUC0-t and AUC0-u221e) of atorvastatin and digoxin | From time 0 to 72 hours (atorvastatin) and 120 hours (digoxin) after respective single doses |
70 secondary outcomes also registered. See the registry record for the full list.
Source: ClinicalTrials.gov (U.S. National Library of Medicine). Last checked against the registry on Nov 1, 2026. See the trial changes feed for what has changed recently.
More trials of UBT251
- UBT251 Injection Phase Ⅲ Study (OSA-PAP) (Phase 3 NCT07806851)
- UBT251 Injection Phase Ⅲ Study (OSA-NPAP) (Phase 3 NCT07767942)
- UNIGUIDE-1: UBT251 Phase 3 in Type 2 Diabetes on Diet and Exercise Alone (Phase 3 NCT07659574)
- UNIGUIDE-2: UBT251 Phase 3 Against Semaglutide in Type 2 Diabetes (Phase 3 NCT07653477)
- UBT251 Phase 3 in Overweight or Obesity (China) (Phase 3 NCT07648225)
- UBT251 Dose-Finding Study in Type 2 Diabetes (Novo Nordisk Phase 2) (Phase 2 NCT07668388)
Research area: Metabolic and incretin. Every registered trial we follow is in the clinical trial tracker, and the labels used on this page are explained in our evidence standards.
