Drug Drug Interaction (DDI) Between Supaglutide and Digoxin or Metformin
A Single-centre, Open Labeled, Fixed-sequence Study to Evaluate the Effect of Supaglutide on Digoxin or Metformin Pharmacokinetics
Asset
Efsubaglutide Alfa
Subcutaneous · GLP-1 agonist
Listed sites
1
Recruiting sites
-
Actual enrollment
34
Study population
Healthy volunteers
Eligibility highlights
•BMI 20-28•Healthy volunteers
Primary endpoints
•Group•Group B
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
Timeline
Milestones
Assets
Investigational agents
Who this study enrolls
Who can enroll
Inclusion criteria
1. Healthy Chinese subjects.
2. Age between 18 and 45 years, inclusive.
3. 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.
4. 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.
Exclusion criteria
1. Subjects with a previous or existing history of serious cardiac, hepatic, renal, gastrointestinal, neurological, psychiatric abnormalities and metabolic abnormalities.
2. 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.
3. 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
4. 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
5. those with existing symptoms of unexplained infection.
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.
Coverage by outcome category
Safety / tolerability / PK
13 endpointsGroup A: Plasma Cmax of digoxin
Time frame:39 Days
concentration, descriptive
Group A: Plasma AUC0-last of digoxin
Time frame:39 Days
concentration, descriptive
Group A: Plasma AUC0-inf of digoxin
Time frame:39 Days
concentration, descriptive
Group B: Plasma Cmax,ss of Metformin
Time frame:34 Days
concentration, descriptive
Group B: Plasma AUC0-tau of Metformin
Time frame:34 Days
concentration, descriptive
Group A: Plasma Tmax of Digoxin
Time frame:39 Days
concentration, descriptive
Group A: Plasma t1/2 of digoxin
Time frame:39 Days
concentration, descriptive
Group A: Plasma CL/F of digoxin
Time frame:39 Days
concentration, descriptive
Group A: Plasma Vz/F of digoxin
Time frame:39 Days
concentration, descriptive
Group B: Plasma Tmax of Metformin
Time frame:34 Days
concentration, descriptive
Group B: Plasma t1/2 of Metformin
Time frame:34 Days
concentration, descriptive
Group B: Plasma CL/F of Metformin
Time frame:34 Days
concentration, descriptive
Group B: Plasma Vz/F of metformin
Time frame:34 Days
concentration, descriptive
Other (unclassified)
1 endpointGroup B: Plasma Cmin,ss of Metformin
Time frame:34 Days
concentration, descriptive
Publications (1)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- PMID40587051via clinicaltrials gov reference derived
Provenance
Sources
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 November 5, 2026 snapshot.