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Obesity &Amp; OverweightPhase 1NCT07065058

A Drug Drug Interaction Study to Evaluate the Effect of VCT220 on the Pharmacokinetics of Repaglinide, Rosuvastatin, and Digoxin in Healthy, Overweight, and Obese Subjects

A Phase 1 study testing Drug: VCT220, Repaglinide, Rosuvastatin, and Digoxin in people with Obesity &Amp; Overweight, run by Vincentage Pharma Co., Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a single-center, open-label, single-arm, fixed-sequence Phase I study in healthy, overweight, and obese subjects. The primary objective is to evaluate the effect of orally administered VCT220 tablets on the pharmacokinetics and safety of repaglinide , rosuvastatin, and digoxin. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Obesity &Amp; Overweight
What is being tested?
Drug: VCT220, Repaglinide, Rosuvastatin, and Digoxin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteChina
Study dates
1 Jul 2025to 11 Aug 2025
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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Subjects must be fully informed of the purpose, content, procedures, and potential adverse reactions of the study, voluntarily agree to participate, and sign the informed consent form (ICF) prior to any study-related procedures.
  • Male and female subjects aged between 18 and 65 years (inclusive).
  • Male subjects must weigh ≥50.0 kg and female subjects ≥45.0 kg, with a body mass index (BMI) ≥20 kg/m² [BMI = weight (kg) / height² (m²)].
  • Subjects must have no plans for childbearing from the time of signing the ICF until 3 months after the last dose of the study drug and must voluntarily agree to use effective contraception; subjects must also have no plans to donate sperm or eggs during this period.
  • Subjects must be able to communicate well with the investigators, and understand and comply with all study requirements.

Who cannot join

  • Any of the following laboratory abnormalities at screening:
  • HbA1c ≥ 6.5%;
  • Fasting plasma glucose (FPG) ≥ 7.0 mmol/L;
  • Estimated glomerular filtration rate (eGFR) < 90 mL/min/1.73m² (calculated by CKD-EPI formula);
  • ALT and/or AST > 1.5× upper limit of normal (ULN);
  • Total bilirubin (TBIL) > 1.5× ULN;
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  • Serum amylase or lipase > 1.5× ULN;
  • Calcitonin ≥ 1.0× ULN;
  • Hemoglobin < 110 g/L (males) or < 100 g/L (females).
  • Positive test results for any of the following: HBsAg, HCV-Ab, HIV-Ab, or TP-Trust (syphilis).
  • 12-lead ECG during screening showing second- or third-degree atrioventricular block, long QT syndrome, QTcF ≥ 450 ms (males) or ≥ 470 ms (females) (QTcF = QT/RR^0.33), bundle branch block, Wolff-Parkinson-White syndrome, or other clinically significant arrhythmias (excluding sinus arrhythmia), or ECG findings deemed clinically significant by the investigator.
  • Known allergy to VCT220, repaglinide, rosuvastatin, or digoxin, or history of allergy to two or more drugs or foods.
  • Presence of clinically significant diseases requiring exclusion, including but not limited to disorders of the nervous, cardiovascular (unless deemed acceptable by the investigator), hematologic, lymphatic, immune, digestive, urinary, respiratory, metabolic, or skeletal systems.
  • History or current diagnosis of pancreatitis (acute or chronic), history of acute gallbladder disease (except for those who have undergone cholecystectomy), or clinically significant findings on baseline abdominal ultrasound.
  • Diagnosis of type 1, type 2, or other specific types of diabetes.
  • Use of GLP-1 receptor agonists within 6 months before screening.
  • Swallowing difficulties or gastrointestinal diseases affecting drug absorption (e.g., diarrhea, vomiting, IBD, acute gastroenteritis, peptic ulcer, or significant GI dysfunction with impaired absorption).
  • Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2.
  • Major depressive disorder or other severe psychiatric disorders within 2 years prior to screening.
  • Surgery within 3 months prior to screening, planned surgery during the study, or history of surgeries that may affect ADME of drugs.
  • History of drug abuse or illicit drug use within 12 months prior to screening, or positive drug screen.
  • Participation in another drug/device trial within 3 months before screening or plans to participate in another clinical trial during the study.
  • Use of oral contraceptives within 30 days before screening (female subjects).
  • Use of long-acting estrogen or progestin injections, hormone-releasing IUDs, or implants within 6 months prior to screening (female subjects).
  • Blood donation (including components) or significant blood loss ≥400 mL, transfusion, or use of blood products within 3 months before screening.
  • Use of any prescription medications (especially those affecting CYP3A4, CYP2C8, CYP2C9, CYP2C19), over-the-counter drugs, herbal supplements, or dietary supplements within 14 days prior to first dosing, or plan to use them during the study.
  • Smoking more than 5 cigarettes per day within 3 months before screening, or inability to abstain from tobacco products during the study.
  • Alcohol consumption >14 units/week (1 unit ≈ 360 mL beer at 5% alcohol, 45 mL liquor at 40%, or 150 mL wine at 12%) within 3 months before screening, inability to abstain during the study, or positive alcohol breath test (>0 mg/100 mL).
  • Excessive consumption of tea, coffee, or other caffeinated beverages (more than 8 cups/day; 1 cup = 250 mL) within 3 months prior to screening, or consumption of any caffeine within 24 hours before dosing, or unwillingness to abstain from caffeine during the study.
  • Consumption of foods or beverages that may affect drug metabolism (e.g., dragon fruit, mango, grapefruit, pomelo, orange) within 2 days before first dose, or unwillingness to avoid such items during the study.
  • Special dietary requirements that prevent adherence to standardized meals.
  • Positive pregnancy test at screening, breastfeeding, or fertile women who had unprotected intercourse within 30 days prior to screening.
  • History of needle phobia, blood phobia, or intolerance to venipuncture.
  • Vaccination within 14 days prior to screening or planned vaccination during the study.
  • Clinically significant abnormalities on physical examination, ECG, labs (CBC, urinalysis, biochemistry, coagulation, fasting C-peptide), abdominal ultrasound, or chest X-ray (PA view), as assessed by the investigator.
  • Vital signs outside the acceptable range at screening and still abnormal upon repeat measurement.
  • Any other condition that the investigator deems makes the subject unsuitable for study participation.

Trial locations and contacts

1 site in 1 country.

China1 site

  • West China Second University Hospital

    Chengdu, Sichuan, 610041

Other trials in China

About this study

Official title: A Phase I, Single-Center, Open-Label, Single-Arm, Fixed-Sequence Clinical Study to Evaluate the Pharmacokinetic Interactions of VCT220 With Repaglinide, Rosuvastatin, and Digoxin in Healthy, Overweight, and Obese Subjects

This is a single-center, open-label, single-arm, fixed-sequence Phase I study in healthy, overweight, and obese subjects. The primary objective is to evaluate the effect of orally administered VCT220 tablets on the pharmacokinetics and safety of repaglinide , rosuvastatin, and digoxin.

A total of 24 subjects will be enrolled. Repaglinide is administered alone on Day 1 and coadministered with VCT220 on Day 72. Rosuvastatin and digoxin are administered together on Day 2 and again on Day 73 with VCT220. VCT220 will be titrated from 20 mg to 160 mg once daily from Day 9 to Day 78.

All study drugs are given under controlled fed or fasting conditions, with standardized water and meal restrictions. Intensive PK sampling will be conducted around dosing to assess any drug-drug interactions. Safety assessments will be conducted throughout the study.

Read the detailed description

This is a single-center, open-label, single-arm, fixed-sequence Phase I clinical study designed to evaluate the effect of orally administered VCT220 tablets on the pharmacokinetics (PK) and safety of repaglinide, rosuvastatin, and digoxin in healthy, overweight, and obese adult subjects. These three drugs are probe substrates for key drug transporters: repaglinide for OATP1B1/OATP1B3, rosuvastatin for BCRP, and digoxin for P-glycoprotein (P-gp).

A total of 24 subjects will be enrolled. On Day 1, subjects receive a single dose of repaglinide 0.5 mg under fasting conditions. On Day 2, rosuvastatin 10 mg and digoxin 0.25 mg are co-administered under fed conditions. From Day 9 to Day 78, subjects will receive VCT220 orally once daily after breakfast in an ascending dose regimen: 20 mg, 40 mg, 80 mg, 120 mg, and finally 160 mg, titrated every 2 weeks.

On Day 72, repaglinide is administered again under fasting conditions, now in the presence of steady-state VCT220. On Day 73, rosuvastatin and digoxin are administered again under fed conditions with VCT220. Water intake is restricted within 1 hour before and after dosing, and standardized meals are provided to control for food effects.

Serial blood samples will be collected before and after dosing for PK assessments. The primary endpoints are the PK parameters (Cmax, AUC) of the probe drugs with and without VCT220. Safety will be evaluated throughout the study via clinical assessments, laboratory tests, vital signs, ECGs, and adverse event monitoring

Being tested
Drug: VCT220, Repaglinide, Rosuvastatin, and Digoxin
Medical subject headings
Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Drug: VCT220, Repaglinide, Rosuvastatin, and DigoxinDrug

    Single dose of Repaglinide at Day 2, Rosuvastatin and Digoxin at Day 3 Orally VCT220 once daily from Day 9 to Day 78, titrated from 20mg to 160mg. Co-administrated Repaglinide at Day 72, co-administrated Rosuvastatin and Digoxin at Day 73

Study groups in NCT07065058
Study groupRoleWhat they receive
Participant GroupExperimentalDuring the monotherapy phase, subjects receive repaglinide, rosuvastatin, and digoxin. After a 1-week washout period, VCT220 is administered starting from 20 mg and titrated up to 160 mg, followed by repeat administration of repaglinide, rosuvastatin, and digoxin.
Receives: Drug: Drug: VCT220, Repaglinide, Rosuvastatin, and Digoxin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pharmacokinetics (PK): Area Under the Concentration-time Curve, From Time 0 to the Last Measurable Concentration (AUC0-t) of Repaglinide

    Measured: 1h before dosing, 0.25 h、0.5 h、1 h、1.5 h、2 h、3 h、4 h、6 h、8 h、12 h and 24 h post dosing

  2. Pharmacokinetics (PK): Area Under the Concentration-time Curve, From Time 0 to the Last Measurable Concentration (AUC0-t) of Rosuvastatin

    Measured: 1h before dosing, 0.5 h、1 h、2 h、3 h、4 h、6 h、8 h、10 h、12 h、16 h、24 h、48 h、72 h、96 h and 120 h post dosing

  3. Pharmacokinetics (PK): Area Under the Concentration-time Curve, From Time 0 to the Last Measurable Concentration (AUC0-t) of Digoxin

    Measured: 1h before dosing, 0.5 h、1 h、2 h、3 h、4 h、6 h、8 h、10 h、12 h、16 h、24 h、48 h、72 h、96 h and 120 h post dosing

  4. Maximum Observed Concentration (Cmax) of Repaglinide

    Measured: 1h before dosing, 0.25 h、0.5 h、1 h、1.5 h、2 h、3 h、4 h、6 h、8 h、12 h and 24 h post dosing

  5. Maximum Observed Concentration of Rosuvastatin

    Measured: 1h before dosing, 0.5 h、1 h、2 h、3 h、4 h、6 h、8 h、10 h、12 h、16 h、24 h、48 h、72 h、96 h and 120 h post dosing

  6. Maximum Observed Concentration (Cmax) of Digoxin

    Measured: 1h before dosing, 0.5 h、1 h、2 h、3 h、4 h、6 h、8 h、10 h、12 h、16 h、24 h、48 h、72 h、96 h and 120 h post dosing

Secondary outcomes (1)

  1. Safety of VCT220

    Adverse events [TEAEs, SAEs], dose interruption, or discontinuation, vital signs (heart rate [beats/min], and changes in laboratory parameters (chemistry, hematology, urinalysis, coagulation).

    Measured: From day 0 to day 78

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2025
  2. Study start1 Jul 2025
  3. Primary completion11 Jul 2025
  4. Study completion11 Aug 2025

Resources

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
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07065058
Sponsor's protocol ID
VCT220-I-04-01
Status last verified
Aug 2025
First submitted
24 Jun 2025
Last updated
31 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Drug: VCT220, Repaglinide, Rosuvastatin, and Digoxin in people with Obesity &Amp; Overweight, run by Vincentage Pharma 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 37 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 31 Mar 2026. 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?

Pharmacokinetics (PK): Area Under the Concentration-time Curve, From Time 0 to the Last Measurable Concentration (AUC0-t) of Repaglinide (time frame: 1h before dosing, 0.25 h、0.5 h、1 h、1.5 h、2 h、3 h、4 h、6 h、8 h、12 h and 24 h post dosing). The study lists 6 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 NCT07065058.

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 31 Mar 2026.

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