CompletedPhase 1

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

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Asset

Mazdutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

Recruiting sites

Actual enrollment

Study population

Obesity / overweight

Eligibility highlights

•BMI 24-30•Male

Primary endpoints

•Plasma concentration (steady state)•AUC of metformin•AUC of warfarin

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05815680

Org study IDCIBI362D101

Timeline

Milestones

Study start2023-04-06actual

Study first posted2023-04-18actual

Primary completion2023-08-18actual

Study completion2023-10-30actual

Last update posted2023-11-14actual

Assets

Investigational agents

Mazdutide

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age18 Years

Maximum age45 Years

SexMale

Healthy volunteersAccepted

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.

Endpoints (14)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

14 endpoints

Primary/protocol endpoint

Maximum observed metformin plasma concentration at steady state

Time frame:up to 116 days

Plasma concentration (steady state)

concentration, descriptive

Primary/protocol endpoint

Area under the metformin plasma concentration-time curve

Time frame:up to 116 days

AUC₀-∞

concentration, descriptive

Primary/protocol endpoint

Maximum observed warfarin plasma concentration at steady state

Time frame:up to 116 days

Plasma concentration (steady state)

concentration, descriptive

Primary/protocol endpoint

Area under the warfarin plasma concentration-time curve

Time frame:up to 116 days

AUC₀-∞

concentration, descriptive

Primary/protocol endpoint

Maximum observed atorvastatin plasma concentration at steady state

Time frame:up to 116 days

Plasma concentration (steady state)

concentration, descriptive

Primary/protocol endpoint

Area under the atorvastatin plasma concentration-time curve

Time frame:up to 116 days

AUC₀-∞

concentration, descriptive

Primary/protocol endpoint

Maximum observed digoxin plasma concentration at steady state

Time frame:up to 116 days

Plasma concentration (steady state)

concentration, descriptive

Primary/protocol endpoint

Area under the digoxin plasma concentration-time curve

Time frame:up to 116 days

AUC₀-∞

concentration, descriptive

Secondary/protocol endpoint

Actual adverse events

Time frame:up to 116 days

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Terminal elimination half-life

Time frame:up to 116 days

Half-life

descriptive

Secondary/protocol endpoint

time to maximum plasma concentration of IBI362

Time frame:up to 116 days

Tmax

descriptive

Secondary/protocol endpoint

Incremental area under the INR (international normalised ratio) -curve of warfarin

Time frame:up to 116 days

concentration, descriptive

Secondary/protocol endpoint

Total apparent clearance of IBI362

Time frame:up to 116 days

descriptive

Secondary/protocol endpoint

Apparent volume of distribution of IBI362

Time frame:up to 116 days

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.