A Study to Evaluate the Drug-drug Interactions (DDIs) of IBI362 With Metformin, Warfarin, Atorvastatin, Digoxin in Overweight or Obese Subjects

This trial is conducted in China. The aim of the trial is to investigate the influence of IBI362 on pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of warfarin, metformin, warfarin, atorvastatin, digoxin in overweight or obese subjects.

Study Overview

• Status: Completed
• Conditions: Overweight Subjects; Obese Subjects
• Intervention / Treatment: Drug: IBI362; Drug: warfarin; Drug: atorvastatin; Drug: metformin; Drug: digoxin

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100049
      • Aerospace Center Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Male, age between 18 and 45 years (both inclusive) at the time of signing informed consent
• Body mass index (BMI) between 24 and 30 kg/m^2 (both inclusive) and weight≥50kg
• The subject has no birth plan and voluntarily takes effective contraceptive measures within 6 months after signing the informed consent form to the last medication

Exclusion Criteria:

• Cardiovascular, respiratory, hepatic, digestive (including digestive diseases that significantly affect gastric emptying or gastric motility, such as severe gastric spasticity or pyloric stenosis), endocrine (including but not limited to history of thyroid cancer or precancerous lesions), hematological and neurological disorders, or muscle degenerative disorders
• Drug or alcohol abuse
• Have dysphagia or any history of gastrointestinal diseases that affect drug absorption.
• Medical history or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.
• Have a history of acute and chronic pancreatitis or serum amylase and/or lipase ≥ upper limit of normal value (Upper Limit of Normal value, ULN) at the time of screening.
• Those with a history of hypoglycemia.
• Previous or current mental illness.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: warfarin+atorvastatin+IBI362	Drug: IBI362; Subjects will initiate treatment with 2 mg for the first four weeks followed by 4mg for four weeks and up to a dose of 6 mg for six weeks.; Drug: warfarin; For oral administration, given as a single dose. The first dose is given before IBI362 treatment and the second dose is given at the end of IBI362 treatment.; Drug: atorvastatin; For oral administration, given as a single dose. The first dose is given before IBI362 treatment and the second dose is given at the end of IBI362 treatment.
Experimental: metformin+digoxin+IBI362	Drug: IBI362; Subjects will initiate treatment with 2 mg for the first four weeks followed by 4mg for four weeks and up to a dose of 6 mg for six weeks.; Drug: metformin; For oral administration, given as a single dose. The first dose is given before IBI362 treatment and the second dose is given at the end of IBI362 treatment.; Drug: digoxin; For oral administration, given as a single dose. The first dose is given before IBI362 treatment and the second dose is given at the end of IBI362 treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum observed metformin plasma concentration at steady state	up to 116 days
Area under the metformin plasma concentration-time curve	up to 116 days
Maximum observed warfarin plasma concentration at steady state	up to 116 days
Area under the warfarin plasma concentration-time curve	up to 116 days
Maximum observed atorvastatin plasma concentration at steady state	up to 116 days
Area under the atorvastatin plasma concentration-time curve	up to 116 days
Maximum observed digoxin plasma concentration at steady state	up to 116 days
Area under the digoxin plasma concentration-time curve	up to 116 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Actual adverse events	up to 116 days
Terminal elimination half-life	up to 116 days
time to maximum plasma concentration of IBI362	up to 116 days
Incremental area under the INR (international normalised ratio) -curve of warfarin	up to 116 days
Total apparent clearance of IBI362	up to 116 days
Apparent volume of distribution of IBI362	up to 116 days

Collaborators and Investigators

• Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2023
• Primary Completion (Actual): August 18, 2023
• Study Completion (Actual): October 30, 2023

Study Registration Dates

• First Submitted: March 20, 2023
• First Submitted That Met QC Criteria: April 4, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Actual): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 12, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Overweight; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Enzyme Inhibitors; Antimetabolites; Protective Agents; Cardiotonic Agents; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Anticoagulants; Digoxin; Atorvastatin; Metformin; Warfarin
• Other Study ID Numbers: CIBI362D101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No