Healthy VolunteersPhase 1NCT05694221
Drug Drug Interaction (DDI) Between Supaglutide and Digoxin or Metformin
A Phase 1 study testing Supaglutide injection, Digoxin and Metformin in people with Healthy Volunteers, run by Shanghai Yinnuo Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
This is a study of a drug drug interaction between Supaglutide and Digoxin or Metformin. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Supaglutide injection, Digoxin and Metformin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2023to 17 Aug 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Chinese subjects.
- Age between 18 and 45 years, inclusive.
- Body mass index [BMI = weight (kg)/height2 (m2)] of between 20 and 28 kg/m2 (including thresholds), with male subjects weighing no less than 50 kg and female subjects weighing no less than 45 kg.
- Subjects with no plan of pragnancy within the screening period up to 3 months after the last dose and who are voluntarily using contraception.
- 6. Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
Who cannot join
- Subjects with a previous or existing history of serious cardiac, hepatic, renal, gastrointestinal, neurological, psychiatric abnormalities and metabolic abnormalities.
- Subjects with a previous or existing disease affecting the absorption, distribution, metabolism or excretion of drugs, such as active peptic ulcers or bleeding, history of ulcers or bleeding, acute and chronic pancreatitis, etc.
- Subjects with a history or family history of C-cell tumours/carcinoma of the thyroid gland, or a previous history of thyroid insufficiency or thyroid hormone abnormalities
- Subjects who have undergone major surgery within 4 weeks prior to screening which, in the judgment of the investigator, may affect this trial, such as gastric and duodenal surgery, cholecystectomy, nephrectomy, or removal of malignant tumours (except for previous appendectomy), or those who are scheduled to undergo major surgery during the trial
- those with existing symptoms of unexplained infection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-centre, Open Labeled, Fixed-sequence Study to Evaluate the Effect of Supaglutide on Digoxin or Metformin Pharmacokinetics
This is a study of a drug drug interaction between Supaglutide and Digoxin or Metformin.
Read the detailed description
This is a single-centre, open labeled, fixed-sequence study designed to assess the pharmacokinetic effects of multiple subcutaneous injections of Supalutide on a single oral dose of digoxin or multiple oral doses of metformin. 32 healthy subjects are planned to be enrolled and allocated to 2 parallel trial groups, Digoxin combined with Sulpalutide injection (Group A) and Metformin combined with Sulpalutide injection (Group B), with 16 cases in each group, of which no less than 4 were of a single sex.
- Conditions
- Healthy Volunteers
- Being tested
- Supaglutide injection, Digoxin, Metformin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supaglutide injectionDrug
Also called Diabegone
Administered subcutaneously in the Supaglutide arms
DigoxinDrug
Also called Digoxin Tablets
Oral Administration
MetforminDrug
Also called Glucophage
Oral Administration
| Study group | Role | What they receive |
|---|---|---|
| Group A: Digoxin combined with Supaglutide group | Experimental | Subjects will receive a single oral dose of 0.25 mg digoxin tablets on Day 1. And will received subcutaneous injection of sulpalutide QW for five weeks（D5-D33）.
Then receive another single oral dose of 0.25 mg digoxin tablets on Day 35. Receives: Drug: Supaglutide injection; Drug: Digoxin |
| Group B: Metformin combined with Supaglutide Group | Experimental | Subjects will receive multiple oral dose of Metformin tablets on Day 1-3. And will received subcutaneous injection of sulpalutide QW for five weeks（D5-D33）.
Then receive another round of Metformin tablets on Day 32-34. Receives: Drug: Supaglutide injection; Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Group A: Plasma Cmax of digoxin
when given in combination with supaglutide in healthy volunteers
Measured: 39 Days
Group A: Plasma AUC0-last of digoxin
when given in combination with suplaglutide in healthy volunteers
Measured: 39 Days
Group A: Plasma AUC0-inf of digoxin
when given in combination with supaglutide in healthy volunteers
Measured: 39 Days
Group B: Plasma Cmax,ss of Metformin
when given in combination with supaglutide in healthy volunteers
Measured: 34 Days
Group B: Plasma AUC0-tau of Metformin
when given in combination with suplaglutide in healthy volunteers
Measured: 34 Days
Secondary outcomes (9)
Group A: Plasma Tmax of Digoxin
when given in combination with supaglutide in healthy volunteers
Measured: 39 Days
Group A: Plasma t1/2 of digoxin
when given in combination with supaglutide in healthy volunteers
Measured: 39 Days
Group A: Plasma CL/F of digoxin
when given in combination with suplaglutide in healthy volunteers
Measured: 39 Days
Group A: Plasma Vz/F of digoxin
when given in combination with supaglutide in healthy volunteers
Measured: 39 Days
Group B: Plasma Tmax of Metformin
when given in combination with supaglutide in healthy volunteers
Measured: 34 Days
Group B: Plasma Cmin,ss of Metformin
when given in combination with suplaglutide in healthy volunteers
Measured: 34 Days
Group B: Plasma t1/2 of Metformin
when given in combination with suplaglutide in healthy volunteers
Measured: 34 Days
Group B: Plasma CL/F of Metformin
when given in combination with suplaglutide in healthy volunteers
Measured: 34 Days
Group B: Plasma Vz/F of metformin
when given in combination with suplaglutide in healthy volunteers
Measured: 34 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start20 Mar 2023
- Primary completion6 Jun 2023
- Study completion17 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.
- Sponsor type
- University, hospital or other
- Collaborators
- Huashan Hospital
- Responsible party
- Sponsor
- Investigators
- Jing Zhang, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05694221
- Sponsor's protocol ID
- YN011-D01
- Status last verified
- Aug 2024
- First submitted
- 12 Jan 2023
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu X, He J, Wu J, Liu W, Xu Y, Li Y, Zhang J, Wang Q. Effect of Efsubaglutide Alfa on the Pharmacokinetics of Metformin and Digoxin in Healthy Participants. Clin Pharmacokinet. 2025 Sep;64(9):1367-1377. doi: 10.1007/s40262-025-01541-0. Epub 2025 Jun 30.
PubMed 40587051
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-centre, Open Labeled, Fixed-sequence Study to Evaluate the Effect of Supaglutide on Digoxin or Metformin Pharmacokinetics
- ClinicalTrials.gov ID
- NCT05694221
- Acronym / sponsor ID
- YN011-D01
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.University, hospital or other
- Collaborators
- Huashan Hospital
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 6 Jun 2023 (actual)
- Study completion
- 17 Aug 2023 (actual)
- First posted
- 23 Jan 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 is a study of a drug drug interaction between Supaglutide and Digoxin or Metformin.
Detailed description
This is a single-centre, open labeled, fixed-sequence study designed to assess the pharmacokinetic effects of multiple subcutaneous injections of Supalutide on a single oral dose of digoxin or multiple oral doses of metformin. 32 healthy subjects are planned to be enrolled and allocated to 2 parallel trial groups, Digoxin combined with Sulpalutide injection (Group A) and Metformin combined with Sulpalutide injection (Group B), with 16 cases in each group, of which no less than 4 were of a single sex.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Digoxin combined with Supaglutide group | Experimental | Drug: Supaglutide injection, Drug: DigoxinSubjects will receive a single oral dose of 0.25 mg digoxin tablets on Day 1. And will received subcutaneous injection of sulpalutide QW for five weeks（D5-D33）. Then receive another single oral dose of 0.25 mg digoxin tablets on Day 35. |
| Group B: Metformin combined with Supaglutide Group | Experimental | Drug: Supaglutide injection, Drug: MetforminSubjects will receive multiple oral dose of Metformin tablets on Day 1-3. And will received subcutaneous injection of sulpalutide QW for five weeks（D5-D33）. Then receive another round of Metformin tablets on Day 32-34. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy Chinese subjects.
- Age between 18 and 45 years, inclusive.
- Body mass index [BMI = weight (kg)/height2 (m2)] of between 20 and 28 kg/m2 (including thresholds), with male subjects weighing no less than 50 kg and female subjects weighing no less than 45 kg.
- Subjects with no plan of pragnancy within the screening period up to 3 months after the last dose and who are voluntarily using contraception.
- 6. Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
Key exclusion criteria (5 listed)
- Subjects with a previous or existing history of serious cardiac, hepatic, renal, gastrointestinal, neurological, psychiatric abnormalities and metabolic abnormalities.
- Subjects with a previous or existing disease affecting the absorption, distribution, metabolism or excretion of drugs, such as active peptic ulcers or bleeding, history of ulcers or bleeding, acute and chronic pancreatitis, etc.
- Subjects with a history or family history of C-cell tumours/carcinoma of the thyroid gland, or a previous history of thyroid insufficiency or thyroid hormone abnormalities
- Subjects who have undergone major surgery within 4 weeks prior to screening which, in the judgment of the investigator, may affect this trial, such as gastric and duodenal surgery, cholecystectomy, nephrectomy, or removal of malignant tumours (except for previous appendectomy), or those who are scheduled to undergo major surgery during the trial
- those with existing symptoms of unexplained infection.
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 |
|---|---|---|
| Supaglutide injectionAlso: DiabegoneAdministered subcutaneously in the Supaglutide arms | Drug | Group A: Digoxin combined with Supaglutide group, Group B: Metformin combined with Supaglutide Group |
| DigoxinAlso: Digoxin TabletsOral Administration | Drug | Group A: Digoxin combined with Supaglutide group |
| MetforminAlso: GlucophageOral Administration | Drug | Group B: Metformin combined with Supaglutide Group |
Primary outcome
Group A: Plasma Cmax of digoxin
Time frame: 39 Days
when given in combination with supaglutide in healthy volunteers
Group A: Plasma AUC0-last of digoxin
Time frame: 39 Days
when given in combination with suplaglutide in healthy volunteers
Group A: Plasma AUC0-inf of digoxin
Time frame: 39 Days
when given in combination with supaglutide in healthy volunteers
Group B: Plasma Cmax,ss of Metformin
Time frame: 34 Days
when given in combination with supaglutide in healthy volunteers
Group B: Plasma AUC0-tau of Metformin
Time frame: 34 Days
when given in combination with suplaglutide in healthy volunteers
9 secondary outcomes
Group A: Plasma Tmax of Digoxin
Time frame: 39 Days
Group A: Plasma t1/2 of digoxin
Time frame: 39 Days
Group A: Plasma CL/F of digoxin
Time frame: 39 Days
Group A: Plasma Vz/F of digoxin
Time frame: 39 Days
Group B: Plasma Tmax of Metformin
Time frame: 34 Days
Group B: Plasma Cmin,ss of Metformin
Time frame: 34 Days
Group B: Plasma t1/2 of Metformin
Time frame: 34 Days
Group B: Plasma CL/F of Metformin
Time frame: 34 Days
Group B: Plasma Vz/F of metformin
Time frame: 34 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 5 Aug 2024.
- Derived from this study: PubMed 40587051Wu X, He J, Wu J, Liu W, Xu Y, Li Y, Zhang J, Wang Q. Effect of Efsubaglutide Alfa on the Pharmacokinetics of Metformin and Digoxin in Healthy Participants. Clin Pharmacokinet. 2025 Sep;64(9):1367-1377. doi: 10.1007/s40262-025-01541-0. Epub 2025 Jun 30.
- Individual participant dataSharing planned: No
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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.
Jing Zhang principal investigator
Huashan Hospital
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 Supaglutide injection, Digoxin and Metformin in people with Healthy Volunteers, run by Shanghai Yinnuo Pharmaceutical Technology 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 5 inclusion and 5 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 5 Aug 2024. 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?
Group A: Plasma Cmax of digoxin (time frame: 39 Days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05694221, which also lists 1 linked publication.
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 5 Aug 2024.