Overweight SubjectsPhase 1NCT05815680
A Study to Evaluate the Drug-drug Interactions (DDIs) of IBI362 With Metformin, Warfarin, Atorvastatin, Digoxin in Overweight or Obese Subjects
A Phase 1 study testing metformin, digoxin and IBI362 in people with Overweight Subjects and Obese Subjects, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight Subjects, Obese Subjects
- What is being tested?
- metformin, digoxin and IBI362
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 6 Apr 2023to 30 Oct 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Overweight Subjects, Obese Subjects
- Being tested
- metformin, digoxin, IBI362, warfarin, atorvastatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metforminDrug
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.
digoxinDrug
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.
IBI362Drug
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.
warfarinDrug
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.
atorvastatinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| warfarin+atorvastatin+IBI362 | Experimental | Not described Receives: Drug: IBI362; Drug: warfarin; Drug: atorvastatin |
| metformin+digoxin+IBI362 | Experimental | Not described Receives: Drug: metformin; Drug: digoxin; Drug: IBI362 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed metformin plasma concentration at steady state
Measured: up to 116 days
Area under the metformin plasma concentration-time curve
Measured: up to 116 days
Maximum observed warfarin plasma concentration at steady state
Measured: up to 116 days
Area under the warfarin plasma concentration-time curve
Measured: up to 116 days
Maximum observed atorvastatin plasma concentration at steady state
Measured: up to 116 days
Area under the atorvastatin plasma concentration-time curve
Measured: up to 116 days
Maximum observed digoxin plasma concentration at steady state
Measured: up to 116 days
Area under the digoxin plasma concentration-time curve
Measured: up to 116 days
Secondary outcomes (6)
Actual adverse events
Measured: up to 116 days
Terminal elimination half-life
Measured: up to 116 days
time to maximum plasma concentration of IBI362
Measured: up to 116 days
Incremental area under the INR (international normalised ratio) -curve of warfarin
Measured: up to 116 days
Total apparent clearance of IBI362
Measured: up to 116 days
Apparent volume of distribution of IBI362
Measured: up to 116 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start6 Apr 2023
- Primary completion18 Aug 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight SubjectsStudies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) Co. Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05815680
- Sponsor's protocol ID
- CIBI362D101
- Status last verified
- Nov 2023
- First submitted
- 20 Mar 2023
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Drug-drug Interactions (DDIs) of IBI362 With Metformin, Warfarin, Atorvastatin, Digoxin in Overweight or Obese Subjects
- ClinicalTrials.gov ID
- NCT05815680
- Acronym / sponsor ID
- CIBI362D101
- Conditions
- Overweight Subjects, Obese Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Apr 2023 (actual)
- Primary completion
- 18 Aug 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| warfarin+atorvastatin+IBI362 | Experimental | Drug: IBI362, Drug: warfarin, Drug: atorvastatin |
| metformin+digoxin+IBI362 | Experimental | Drug: metformin, Drug: digoxin, Drug: IBI362 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| metforminFor 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 | metformin+digoxin+IBI362 |
| digoxinFor 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 | metformin+digoxin+IBI362 |
| IBI362Subjects 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+digoxin+IBI362, warfarin+atorvastatin+IBI362 |
| warfarinFor 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 | warfarin+atorvastatin+IBI362 |
| atorvastatinFor 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 | warfarin+atorvastatin+IBI362 |
Primary outcome
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
6 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing metformin, digoxin and IBI362 in people with Overweight Subjects and Obese Subjects, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum observed metformin plasma concentration at steady state (time frame: up to 116 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2023.