Influence of HDM1005 on Gastric Emptying and Pharmacokinetics of Metformin, Atorvastatin, Warfarin, and Digoxin

A Phase I, Single-center, Open-Label, Single-Arm, Fixed-Sequence Study to Evaluate the Influence of HDM1005 on Gastric Emptying and Drug-Drug Interaction of HDM1005 and Metformin, Atorvastatin, Warfarin, and Digoxin in Overweight/Obese Adult Chinese Subjects

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obesity; Overweight
• Intervention / Treatment: Drug: Atorvastatin; Drug: Digoxin; Drug: Warfarin; Drug: Acetaminophen; Drug: Metformin; Drug: HDM1005 injection

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Hefei, China
    • The Second Affiliated Hospital of Anhui Medical University
    • Contact: Mengxia Zhang; Phone Number: +86 15524433179; Email: zhangmengxia@eastchinapharm.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• Blood donation, significant blood loss (≥400 mL), or use of blood products within 3 months prior to screening or between screening and the first dose.
• Use of prescription or over-the-counter medications, health supplements, or herbal medicines within 2 weeks prior to IMP administration, or still within 5 half-lives of such medications, whichever is longer (excluding contraceptives).
• Participation in any clinical trial and use of investigational product within 3 months prior to screening, or still within 5 half-lives of the investigational product from a previous trial at the time of screening (whichever is longer).
• Female participants who are breastfeeding or pregnant.
• Participants with any other factors that, in the opinion of the investigator, make them unsuitable for participation in this trial (e.g., medical, psychological, or psychiatric conditions, social or geographical factors)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group	Drug: Atorvastatin; Single dose; Administered orally; Drug: Digoxin; Single dose; Administered orally; Drug: Warfarin; Single dose; Administered orally; Drug: Acetaminophen; Single dose; Administered orally; Drug: Metformin; Single dose; Administered orally; Drug: HDM1005 injection; Subcutaneous injection QW

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 ∞	Up to Day 115
Maximum observed concentration (Cmax)	PK parameter of Acetaminophen, Metformin, Atorvastatin, Warfarin, and Digoxin: Maximum observed concentration	Up to Day 115
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	Up to Day 115
Time of maximum observed concentration (Tmax)	PK parameter of Acetaminophen: Time of maximum observed concentration	Up to Day 115

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events (AEs)	Number of subjects reporting AEs	Up to Day 115
Apparent volume of distribution (Vz/F)	PK parameter of Acetaminophen, Metformin, Atorvastatin, Warfarin, and Digoxin	Up to Day 115
Time of maximum observed concentration (Tmax)	PK parameter of HDM1005, Metformin, Atorvastatin, Warfarin, and Digoxin	Up to Day 115
Maximum observed concentration (Cmax)	PK parameter of HDM1005	Up to Day 115
Area Under the Concentration Time Curve From Time Zero to t [ AUC(0- t)]	PK parameter of HDM1005	Up to Day 115

Collaborators and Investigators

• Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): April 8, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 2, 2027

Study Registration Dates

• First Submitted: March 19, 2026
• First Submitted That Met QC Criteria: March 24, 2026
• First Posted (Actual): March 30, 2026

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pyrans; Fatty Acids; Lipids; Azoles; Carbohydrates; Polycyclic Compounds; Glycosides; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Steroids; Fused-Ring Compounds; Pyrroles; Heptanoic Acids; Biguanides; Guanidines; Amidines; Coumarins; Benzopyrans; Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; 4-Hydroxycoumarins; Atorvastatin; Acetaminophen; Digoxin; Metformin; Warfarin
• Other Study ID Numbers: HDM1005-104

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No