← Trials/Trial dossier/NCT06247748
Influence of JY09 on Pharmacokinetics of Metformin , Rosuvastatin , and Digoxin and the QT Interval Study in Overweight Chinese Subjects
Evaluation of the Effects of Exendin-4 Fc Fusion Protein (JY09) Injection on the Pharmacokinetic Profiles of Metformin Hydrochloride Tablets, Rosuvastatin Calcium Tablets, and Digoxin Tablets and on the QT Interval in Overweight Chinese Subjects
Lead sponsor
Asset
Exenatide
GLP-1 agonist
Listed sites
1
Recruiting sites
—
Enrollment
28
actual
Study population
Healthy volunteers, Obesity / overweight
Key I/E criterion
•BMI 24-28
Primary endpoints
•Metformin Peak Concentration (Cmax )•AUC of Metformin blood•Rosuvastatin Peak Concentration (Cmax )
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Age: Overweight subjects with full capacity for civil behavior who are ≥ 18 years old and ≤ 45 years old (the ratio of the number of subjects of either sex is not less than 1/3).
2. Body weight: men ≥ 50.0 kg, women ≥ 45.0 kg, body mass index (BMI) ≥ 24.0 kg/m2 and ≤ 28.0 kg/m2 , BMI = weight (kg)/height (m2 ).
3. Those who do not plan to have children in the last 6 months, do not plan to donate sperm/eggs, and are willing to use effective contraception for 6 months after the end of dosing.
4. Fully understand the trial and possible adverse effects, have the ability to communicate normally with the investigator, as well as comply with study requirements, follow protocol procedures and limitations, and be able to visit on time.
5. Understand the content of the informed consent form, agree to participate in this trial and voluntarily sign the consent form.
Exclusion criteria
1. A clear history of central nervous system, cardiovascular system, renal, hepatic, pulmonary, metabolic, and musculoskeletal disorders or other notable diseases.
2. Individuals with gastrointestinal disorders, such as history of hepatobiliary disease, history of gastrointestinal disease, history of gastrointestinal surgery (except appendectomy) or history of chronic pancreatitis or idiopathic acute pancreatitis, and those with habitual diarrhea.
3. Previous tip-twisting ventricular tachycardia or other risk factors that can lead to malignant arrhythmias, or a family history of first-degree relatives (i.e., biological parents, siblings, or children) with short QT syndrome, long QT syndrome, unexplained sudden death, drowning, or sudden infant death syndrome in young adulthood (less than/equal to 40 years of age), or cardiac conduction block.
4. Have disorders of electrolyte metabolism such as hyperkalemia, hypokalemia, hypomagnesemia, hypomagnesemia, hypercalcemia or hypocalcemia.
5. If the results of vital signs (blood pressure, pulse, respiration, temperature) are abnormal and clinically significant, a retest is allowed to confirm the results if they are abnormal, and the abnormal values of each vital sign.
6. Physical examination, laboratory tests, 12-lead electrocardiogram (ECG), abdominal ultrasound, calcitonin and chest radiographs (orthopantomograms) suggesting the presence of abnormalities judged by the investigator to be clinically significant (retesting was allowed once).
7. Smokers who smoked an average of more than 5 cigarettes per day in the 3 months prior to screening or who could not give up smoking during their participation in the trial or who had a positive smoke test.
8. Those who have participated in other clinical trials as a subject within 3 months prior to screening.
9. Those who donated blood or blood products ≥400 mL within 3 months prior to screening.
10. Those who cannot tolerate venipuncture and have a history of needle and blood sickness.
Endpoints (33)
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
Weight & body composition
6 endpointsBody fat mass
Time frame:Day19 or Day20,Day103 or Day104.
Total fat mass
descriptive, improvement
Body fat percentage
Time frame:Day19 or Day20,Day103 or Day104.
Total fat mass
descriptive, improvement
Fat-free weight
Time frame:Day19 or Day20,Day103 or Day104.
Lean mass
descriptive, improvement
Skeletal muscle mass
Time frame:Day19 or Day20,Day103 or Day104.
Lean mass
descriptive, improvement
Waist-to-hip ratio
Time frame:Day19 or Day20,Day103 or Day104.
ratio, improvement
Visceral fat area
Time frame:Day19 or Day20,Day103 or Day104.
Visceral fat, change
change from baseline, improvement
Glycemic / diabetes
5 endpointsArea Under the Effect Curve from time 0 to the last measurable concentration (AUEC0-t )
Time frame:From time 0 to 240 minutes after Oral glucose(Day21) and Oral glucose(Day84).
descriptive
The Peak Effect Concentration(ECmax）
Time frame:From time 0 to 240 minutes after Oral glucose(Day21) and Oral glucose(Day84).
concentration, descriptive
Maximum Effect Time(ETmax )
Time frame:From time 0 to 240 minutes after Oral glucose(Day21) and Oral glucose(Day84).
descriptive
(AUEC0-t after JY09 administration - AUEC0-t before JY09 administration)/AUEClast before JY09 administration ×100%(Δ%AUEC0-t)
Time frame:From time 0 to 240 minutes after Oral glucose(Day21) and Oral glucose(Day84).
percent change from baseline, improvement
(post-administration Maximum Effect(Emax)- pre-administration Maximum Effect(Emax))/pre-administration Maximum Effect(Emax)×100%(Δ%Emax )
Time frame:From time 0 to 240 minutes after Oral glucose(Day21) and Oral glucose(Day84).
percent change from baseline, improvement
Cardiometabolic biomarkers
2 endpointsVital signs-Blood pressure
Time frame:From baseline (Day -1) to follow-up (Day 123)
change from baseline, improvement
Vital signs-Pulse
Time frame:From baseline (Day -1) to follow-up (Day 123)
Heart rate, change
change from baseline, improvement
Safety / tolerability / PK
13 endpointsThe Metformin Peak Concentration (Cmax )
Time frame:During a dosing interval (0-36 hours) after the last of 7 repeated doses of metformin without JY09 exposure (Day 4) and at JY09 steady state (Day 88)
Cmax
concentration, descriptive
Area under the Metformin blood concentration-time curve
Time frame:During a dosing interval (0-36 hours) after the last of 7 repeated doses of metformin without JY09 exposure (Day 4) and at JY09 steady state (Day 88)
AUC₀–∞
concentration, descriptive
The Rosuvastatin Peak Concentration (Cmax )
Time frame:From time 0 to 96 hours after a single dose of Rosuvastatin without JY09 exposure (Day 8) and at JY09 steady state (Day 95)
Cmax
concentration, descriptive
Area under the Rosuvastatin blood concentration-time curve
Time frame:From time 0 to 96 hours after a single dose of Rosuvastatin without JY09 exposure (Day 8) and at JY09 steady state (Day 95)
AUC₀–∞
concentration, descriptive
The Digoxin Peak Concentration (Cmax )
Time frame:From time 0 to 168 hours after a single dose of Digoxin without JY09 exposure (Day 15) and at JY09 steady state (Day 102)
Cmax
concentration, descriptive
Baseline-corrected difference of Corrected QT interval after multiple subcutaneous injections of JY09 injection
Time frame:From time 0 to 72 hours after a single dose of JY09 (Day 22) and at JY09 steady state (Day 92)
change from baseline, descriptive
Safety endpoint-Adverse events
Time frame:From baseline (Day -1) to follow-up (Day 123)
Treatment-emergent AEs (any)
descriptive, event
Physical examination
Time frame:From baseline (Day -1) to follow-up (Day 123)
descriptive
Laboratory tests-Routine blood
Time frame:From baseline (Day -1) to follow-up (Day 123)
descriptive
Laboratory tests-Urine routine
Time frame:From baseline (Day -1) to follow-up (Day 123)
descriptive
12-lead electrocardiogram (ECG)
Time frame:From baseline (Day -1) to follow-up (Day 123)
descriptive
Immunogenicity
Time frame:From baseline (Day -1) to follow-up (Day 123)
Immunogenicity (ADA)
descriptive
Pharmacodynamically relevant plasma endogenous markers（If necessary）
Time frame:From time 0 to 72 hours after a single dose of JY09 (Day 22) and at JY09 steady state (Day 92) and Day21，Day29，Day43，Day83
concentration, descriptive
Other (unclassified)
7 endpointsVital signs-Respiration
Time frame:From baseline (Day -1) to follow-up (Day 123)
change from baseline, descriptive
Laboratory tests-Blood biochemistry
Time frame:From baseline (Day -1) to follow-up (Day 123)
descriptive
Laboratory tests-coagulation function
Time frame:From baseline (Day -1) to follow-up (Day 123)
descriptive
Pharmacodynamically relevant plasma metabolomics(if necessary)
Time frame:From time 0 to 72 hours after a single dose of JY09 (Day 22) and at JY09 steady state (Day 92) and Day21，Day29，Day43，Day83
descriptive
Blood Cell Genotype Characterization (if necessary)
Time frame:Day21，Day29，Day43，Day83
descriptive
Bacteria genus
Time frame:Day21 or Day22,Day84 or Day85
descriptive
Relative abundance
Time frame:Day21 or Day22,Day84 or Day85
descriptive
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 July 1, 2026 snapshot.