The purpose of this study is to characterize the Influence of HDM1005 on gastric emptying and drug-drug interaction of HDM1005 and metformin, atorvastatin, warfarin, and digoxin in overweight/obese adult subjects.
Aged between 18 and 45 years (inclusive), regardless of gender.
Male participants with body weight ≥50.0 kg, female participants with body weight ≥45.0 kg, and body mass index (BMI = weight [kg]/height² [m²]) within the range of 24.0 to 35.0 kg/m² (inclusive).
In the opinion of the investigator, participants are in generally good health based on medical history, clinical laboratory tests, vital signs, 12-lead ECG results, and physical examination findings at screening.
Provide signed informed consent form (ICF) prior to the trial, and have a thorough understanding of the trial content, procedures, and possible adverse reactions. Participants must be able to communicate well with the investigator, and understand and comply with the requirements of this study.
Participants with a medical history or family history of medullary thyroid carcinoma (MTC), thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2).
History of chronic pancreatitis or an episode of acute pancreatitis within 3 months prior to screening.
History of an acute episode of cholecystitis within 3 months prior to screening.
Experienced severe hypoglycemic events or recurrent hypoglycemic events (≥3 hypoglycemic events per week, or other hypoglycemic events as judged by the investigator) within 3 months prior to screening.
Single group
Acetaminophen
DrugSingle dose; Administered orally
Metformin
DrugSingle dose; Administered orally
Warfarin
DrugSingle dose; Administered orally
Atorvastatin
DrugSingle dose; Administered orally
Digoxin
DrugSingle dose; Administered orally
HDM1005 injection
DrugSubcutaneous injection QW
Area Under the Concentration Time Curve From Time Zero to ∞ [ AUC(0- ∞)]
PK parameter of Metformin, Atorvastatin, Warfarin, and Digoxin: Area under the curve from time 0 hour to ∞
Maximum observed concentration (Cmax)
PK parameter of Acetaminophen, Metformin, Atorvastatin, Warfarin, and Digoxin: Maximum observed concentration
Area Under the Concentration Time Curve From Time Zero to t [ AUC(0- t)]
PK parameter of Acetaminophen, Metformin, Atorvastatin, Warfarin, and Digoxin: Area under the curve from time 0 hour to t
Time of maximum observed concentration (Tmax)
PK parameter of Acetaminophen: Time of maximum observed concentration
Adverse events (AEs)
Number of subjects reporting AEs
Apparent volume of distribution (Vz/F)
PK parameter of Acetaminophen, Metformin, Atorvastatin, Warfarin, and Digoxin
Time of maximum observed concentration (Tmax)
PK parameter of HDM1005, Metformin, Atorvastatin, Warfarin, and Digoxin
Maximum observed concentration (Cmax)
PK parameter of HDM1005
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