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

NCT07785934 | Recruiting Phase 1

• 1 other identifier: TUL-UBT251(Ⅰ-6)202508
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

UBT251 Injection; Drug-Drug Interactions; Pharmacokinetics; Pharmacodynamics; Obesity; Overweight

Outcome Measures

Primary Outcomes (2)

• Area under plasma concentration-time curve of metformin (AUC0-τ) and S-warfarin, R-warfarin (AUC0-t, AUC0-∞)

  Compare AUC0-τ of metformin after multiple-dose administration alone, and AUC0-t and AUC0-∞ of S-warfarin and R-warfarin after single-dose administration alone, with the corresponding parameters when these drugs are administered following dose-escalated and continued 6.0 mg UBT251 in Cohort 1.

  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-∞) of atorvastatin and digoxin

  Compare AUC0-t and AUC0-∞ of single-dose atorvastatin and single-dose digoxin administered alone, with corresponding parameters when administered following dose-escalated and continued 6.0 mg UBT251 in Cohort 2.

  From time 0 to 72 hours (atorvastatin) and 120 hours (digoxin) after respective single doses

Secondary Outcomes (70)

• Peak Plasma Concentration (Cmax) of metformin in Cohort 1

  Up to 30 hours following last dose at steady-state

• Time to Peak Plasma Concentration (Tmax) of metformin in Cohort 1

  Up to 30 hours following last dose at steady-state

• Area under the plasma concentration-time curve from 0 to last measurable time point (AUC0-t) of metformin in Cohort 1

  Pre-dose and up to 30 hours following last dose at steady-state

• Area under the plasma concentration-time curve from 0 to infinity (AUC0-∞) of metformin in Cohort 1

  Pre-dose and up to 30 hours following last dose at steady-state

• Apparent volume of distribution (Vz/F) of metformin in Cohort 1

  Pre-dose and up to 30 hours following last dose at steady-state

Study Arms (1)

UBT251

EXPERIMENTAL

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.

Drug: UBT251; Drug: Metformin hydrochloride; Drug: Warfarin Sodium; Drug: Atorvastatin calcium; Drug: Digoxin

Interventions

UBT251 DRUG

Subcutaneous injection administered once weekly with dose escalation

UBT251

Metformin hydrochloride DRUG

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

UBT251

Warfarin Sodium DRUG

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

UBT251

Atorvastatin calcium DRUG

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

UBT251

Digoxin DRUG

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

UBT251

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participants with overweight or obesity, aged 18-45 years inclusive; Cohort 1 includes male participants only, and Cohort 2 includes both male and female participants.
• Body weight ≥50.0 kg, body mass index (BMI) ranging from 24.0 to 35.0 kg/m² inclusive (BMI = weight(kg)/height²(m²)).
• Participants (including their partners) have no plan to conceive from screening through 6 months after study completion, are willing to adopt contraceptive measures specified in the study, and have no plan to donate sperm or ova within 6 months after trial completion.
• Participants are able to communicate well with investigators, have fully understood this study, voluntarily participate in it, understand and comply with all study requirements, and provide written informed consent.

You may not qualify if:

• Known hypersensitivity or intolerance to investigational product or its excipients, or hypersensitivity to other GLP-1, GIP, GCG receptor agonists; or prior history of multiple or severe clinically significant drug hypersensitivity reactions; or active allergic disease or high-sensitivity constitution;
• History or evidence of any of the following diseases:
• Personal or family history (first-degree relatives: parents, children or siblings) of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2);
• History of malignancy within 5 years prior to screening, except for adequately treated carcinoma in situ of the cervix, basal-cell or squamous-cell skin cancer, radically resected local prostate cancer, and radically resected ductal carcinoma in situ of the breast;
• History of acute or chronic pancreatitis, pancreatic injury, or pancreatic surgery;
• History of acute cholecystitis, cholelithiasis or severe gallbladder polyps within 6 months prior to screening, for which the investigator assesses that study participation may increase the participant's risk;
• History of dysphagia or any gastrointestinal disorder affecting drug absorption;
• Cardiovascular, respiratory, hepatic, gastrointestinal (including disorders markedly affecting gastric emptying or gastric motility, e.g. severe gastric spasm or pyloric stenosis), endocrine (including but not limited to history of thyroid carcinoma or preneoplastic lesions), hematological, neurological diseases, or muscular degenerative disorders that may significantly affect drug absorption, metabolism or elimination, increase participant risk, or confound data interpretation;
• History of severe hypoglycemic coma; or ≥3 episodes of blood glucose \<3.9 mmol/L within any one week in the 2 months before screening (regardless of symptoms); or ≥1 episode of severe hypoglycemia per month within 2 months before screening (blood glucose \<3.0 mmol/L accompanied by cognitive impairment or requiring third-party assistance);
• History of severe psychiatric disorders (including but not limited to suicidal ideation or suicide attempt, schizophrenia, bipolar disorder); or Patient Health Questionnaire-9 (PHQ-9) score ≥10 at screening;
• Severe infection, trauma or major surgical operation within 4 weeks prior to screening; or planned surgical procedure during the study;
• History of bariatric surgery for obesity;
• Use of dipeptidyl peptidase-4 (DPP-4) inhibitors, GLP-1, GCG, GIP or amylin-targeted agents (e.g. exenatide, liraglutide, lixisenatide, semaglutide, tirzepatide, mazdutide, etc.) within 2 months before drug administration; or prior intolerance to the above-mentioned agents;
• Use of any medicinal products within 14 days or 5 half-lives (whichever is longer) prior to drug administration; and planned use of any medicinal products (prescription, over-the-counter, herbal medicines) and/or dietary supplements during the study;
• Abnormal findings with clinical significance as judged by the investigator in physical examination, vital signs, 12-lead electrocardiogram, or abdominal ultrasound at screening (mild-to-moderate fatty liver is excluded);

Sponsors & Collaborators

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

Study Sites (1)

The Second Hospital of Anhui Medical University

Hefei, Anhui, 230061, China

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight

Interventions

Metformin; Warfarin; Atorvastatin; Digoxin

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pyrroles; Azoles; Heptanoic Acids; Fatty Acids; Lipids; Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Glycosides; Carbohydrates

Central Study Contacts

Wei Hu, PhD

CONTACT

+86-13856086475; hwgcp@ayefy.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2026
• First Posted: August 25, 2026
• Study Start: May 27, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 25, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)