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

NCT07502001 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: HDM1005-104
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Overweight; Obesity

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Adverse events (AEs)

  Up to Day 115

• Apparent volume of distribution (Vz/F)

  Up to Day 115

• Time of maximum observed concentration (Tmax)

  Up to Day 115

• Maximum observed concentration (Cmax)

  Up to Day 115

• Area Under the Concentration Time Curve From Time Zero to t [ AUC(0- t)]

  Up to Day 115

Study Arms (1)

Treatment group

EXPERIMENTAL

Drug: Acetaminophen; Drug: Metformin; Drug: Warfarin; Drug: Atorvastatin; Drug: Digoxin; Drug: HDM1005 injection

Interventions

Acetaminophen DRUG

Single dose; Administered orally

Treatment group

Metformin DRUG

Single dose; Administered orally

Treatment group

Warfarin DRUG

Single dose; Administered orally

Treatment group

Atorvastatin DRUG

Single dose; Administered orally

Treatment group

Digoxin DRUG

Single dose; Administered orally

Treatment group

HDM1005 injection DRUG

Subcutaneous injection QW

Treatment group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

The Second Affiliated Hospital of Anhui Medical University

Hefei, China

Location

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Acetaminophen; Metformin; Warfarin; Atorvastatin; Digoxin

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Biguanides; Guanidines; Amidines; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pyrroles; Azoles; Heptanoic Acids; Fatty Acids; Lipids; Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Glycosides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: March 30, 2026
• Study Start: April 8, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 2, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

CN (1)