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← All trials/NCT05694221

CompletedPhase 1

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

NCT IDNCT05694221
Org study IDYN011-D01

Timeline

Milestones

Study first posted2023-01-23actual
Study start2023-03-20actual
Primary completion2023-06-06actual
Study completion2023-08-17actual
Last update posted2024-08-05actual

Assets

Investigational agents

Who this study enrolls

Healthy volunteers

Who can enroll

Minimum age18 Years
Maximum age45 Years
SexAll
Healthy volunteersAccepted

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
Other (unclassified)
1

Safety / tolerability / PK

13 endpoints
Primary/protocol endpoint

Group A: Plasma Cmax of digoxin

Time frame:39 Days

concentration, descriptive

Primary/protocol endpoint

Group A: Plasma AUC0-last of digoxin

Time frame:39 Days

concentration, descriptive

Primary/protocol endpoint

Group A: Plasma AUC0-inf of digoxin

Time frame:39 Days

concentration, descriptive

Primary/protocol endpoint

Group B: Plasma Cmax,ss of Metformin

Time frame:34 Days

concentration, descriptive

Primary/protocol endpoint

Group B: Plasma AUC0-tau of Metformin

Time frame:34 Days

concentration, descriptive

Secondary/protocol endpoint

Group A: Plasma Tmax of Digoxin

Time frame:39 Days

concentration, descriptive

Secondary/protocol endpoint

Group A: Plasma t1/2 of digoxin

Time frame:39 Days

concentration, descriptive

Secondary/protocol endpoint

Group A: Plasma CL/F of digoxin

Time frame:39 Days

concentration, descriptive

Secondary/protocol endpoint

Group A: Plasma Vz/F of digoxin

Time frame:39 Days

concentration, descriptive

Secondary/protocol endpoint

Group B: Plasma Tmax of Metformin

Time frame:34 Days

concentration, descriptive

Secondary/protocol endpoint

Group B: Plasma t1/2 of Metformin

Time frame:34 Days

concentration, descriptive

Secondary/protocol endpoint

Group B: Plasma CL/F of Metformin

Time frame:34 Days

concentration, descriptive

Secondary/protocol endpoint

Group B: Plasma Vz/F of metformin

Time frame:34 Days

concentration, descriptive

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Group 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.

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateNovember 5, 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 November 5, 2026 snapshot.