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NCT05815680·Phase 1·INTERVENTIONAL

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

Status

Completed

Phase

Phase 1

Enrollment

48

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

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.

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.

Timeline

From registration to results.

  1. First posted

    Apr 18, 2023

  2. Study start

    Apr 6, 2023

  3. Primary completion

    Aug 18, 2023

  4. Study completion

    Oct 30, 2023

  5. Results posted

    Not reported

  6. Registry updated

    Nov 14, 2023

Outcomes

What the study measures.

Primary outcomes

Maximum observed metformin plasma concentration at steady state

Time frame · up to 116 days

Area under the metformin plasma concentration-time curve

Time frame · up to 116 days

Maximum observed warfarin plasma concentration at steady state

Time frame · up to 116 days

Area under the warfarin plasma concentration-time curve

Time frame · up to 116 days

Maximum observed atorvastatin plasma concentration at steady state

Time frame · up to 116 days

Area under the atorvastatin plasma concentration-time curve

Time frame · up to 116 days

Maximum observed digoxin plasma concentration at steady state

Time frame · up to 116 days

Area under the digoxin plasma concentration-time curve

Time frame · up to 116 days

Secondary outcomes

Actual adverse events

Time frame · up to 116 days

Terminal elimination half-life

Time frame · up to 116 days

time to maximum plasma concentration of IBI362

Time frame · up to 116 days

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

Time frame · up to 116 days

Total apparent clearance of IBI362

Time frame · up to 116 days

Apparent volume of distribution of IBI362

Time frame · up to 116 days

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
45 Years
Sex
MALE
Healthy volunteers
Yes

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 locations

1 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

Aerospace Center Hospital

Beijing, Beijing Municipality, China

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

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