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NCT Number: NCT07502001

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Acetaminophen

Drug

Single dose; Administered orally

metformin

Drug

Single dose; Administered orally

Warfarin

Drug

Single dose; Administered orally

atorvastatin

Drug

Single dose; Administered orally

Digoxin

Drug

Single dose; Administered orally

HDM1005 injection

Drug

Subcutaneous injection QW

Primary outcomes

  1. Area Under the Concentration Time Curve From Time Zero to ∞ [ AUC(0- ∞)]

    Time frame: Up to Day 115

    PK parameter of Metformin, Atorvastatin, Warfarin, and Digoxin: Area under the curve from time 0 hour to ∞

  2. Maximum observed concentration (Cmax)

    Time frame: Up to Day 115

    PK parameter of Acetaminophen, Metformin, Atorvastatin, Warfarin, and Digoxin: Maximum observed concentration

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

    Time frame: Up to Day 115

    PK parameter of Acetaminophen, Metformin, Atorvastatin, Warfarin, and Digoxin: Area under the curve from time 0 hour to t

  4. Time of maximum observed concentration (Tmax)

    Time frame: Up to Day 115

    PK parameter of Acetaminophen: Time of maximum observed concentration

Secondary outcomes

  1. Adverse events (AEs)

    Time frame: Up to Day 115

    Number of subjects reporting AEs

  2. Apparent volume of distribution (Vz/F)

    Time frame: Up to Day 115

    PK parameter of Acetaminophen, Metformin, Atorvastatin, Warfarin, and Digoxin

  3. Time of maximum observed concentration (Tmax)

    Time frame: Up to Day 115

    PK parameter of HDM1005, Metformin, Atorvastatin, Warfarin, and Digoxin

  4. Maximum observed concentration (Cmax)

    Time frame: Up to Day 115

    PK parameter of HDM1005

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

    Time frame: Up to Day 115

    PK parameter of HDM1005

Sponsors and collaborators

Lead sponsor

Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Mar 30, 2026
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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