Phase Ib Clinical Study of HDM1005 Injection

NCT06637020 | Completed Phase 1 FDA Drug

• 1 other identifier: HDM1005-102
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized, double-blind, placebo-controlled, multiple-dose, dose-escalation study in overweight or obese subjects to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) characteristics of HDM1005 injection in overweight or obese subjects.

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (1)

• The incidence, severity, and causality of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)

  Safety Outcomes . The incidence, severity, and causality of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) occurring during the study period; TEAEs leading to early study termination; TEAEs leading to death, etc.

  Signing informed until day 57

Secondary Outcomes (1)

• area under the concentration- time curve from time zero to time t (AUC0-t).

  Before the first dose to 672 hours after the last dose

Other Outcomes (5)

• Changes of weight in kilogram

  Baseline to day 29

• BMI in kg/m^2

  Baseline to day 29

• Changes of glucose

  Baseline to day 29

Study Arms (4)

HDM1005 injection dose level 1

EXPERIMENTAL

HDM1005 injection or pleacebo dose level 1 qw subcutaneous injection, 4weeks

Drug: HDM1005 injection or placebo

HDM1005 injection dose level 2

EXPERIMENTAL

HDM1005 injection or pleacebo dose level 2 qw subcutaneous injection, 4weeks

Drug: HDM1005 injection or placebo

HDM1005 injection dose level 3

EXPERIMENTAL

HDM1005 injection or pleacebo dose level 3 qw subcutaneous injection, 4weeks

Drug: HDM1005 injection or placebo

HDM1005 injection dose level 4

EXPERIMENTAL

HDM1005 injection or pleacebo dose level 3 qw subcutaneously administered once weekly, for 2 times; subsequently increased to dose level 4 once weekly for 2 times.

Drug: HDM1005 injection or placebo

Interventions

HDM1005 injection or placebo DRUG

Within each cohort, subjects are randomized in a 4:1 ratio to receive either HDM1005 injection or placebo subcutaneously.

Also known as: HDM1005

HDM1005 injection dose level 1; HDM1005 injection dose level 2; HDM1005 injection dose level 3; HDM1005 injection dose level 4

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects aged 18 to 65 years old (inclusive).
• BMI \>27.0 kg/m² and \< 40.0 kg/m² at screening and randomization.
• Blood pressure \< 160/100 mmHg and pulse rate between 50-100 bpm (inclusive) at screening.
• Female subjects of childbearing potential must have used and agreed to continue using effective contraception methods for at least 14 days prior to signing the ICF and up to 2 months after dosing, and have no plans to have children or donate eggs. Male subjects must have no plans to have children or donate sperm from the date of signing the ICF to 4 months after dosing, and they must agree to use effective contraception methods.
• Able to understand the procedures and methods used in the study, voluntarily sign the ICF, and willing to strictly adhere to the requirements of the clinical trial protocol to complete the relevant procedures.

You may not qualify if:

• Subjects who meet any of the following criteria will be excluded:
• Within 3 months before screening, subjects' body weight changed by ≥5%
• Previously diagnosed with type 1, type 2, or another type of diabetes
• Diagnosis of overweight or obesity due to other diseases or medications
• History or family history of medullary thyroid carcinoma, thyroid C-cell hyperplasia, or multiple endocrine adenomatosis type 2
• As determined by the investigator, the subjects have co-existing diseases or conditions that affect gastric emptying or gastrointestinal nutrient absorption.
• Cardiovascular and cerebrovascular diseases, gastrointestinal diseases, diabetes mellitus, medullary thyroid cancer, thyroid C cell hyperplasia, multiple endocrine adenomatosis type 2, chronic pancreatitis, and malignant tumors with obvious clinical significance were present; And any respiratory, neurological, urogenital, hematological, or endocrine disorders that may affect the safety of the subject or the findings of the study
• Any malignancy within 5 years prior to signing the ICF (except for basal cell carcinoma that has received curative treatment and is considered cured)
• Patients who have undergone major surgery within 3 months before signing the ICF, or who plan to undergo surgery during the study period
• Previous or combined depression or other mental disorders
• Known intolerance or allergy to any component of the investigational drug or GLP-1 receptor (GLP-1R) agonists; Or have a history of severe drug allergies
• Use of GLP-1R agonists within 6 months before signing the ICF
• Drugs that have been used within 3 months before signing ICF and have been determined by researchers to significantly affect weight and glucose
• For subjects taking lipid-lowering drugs, the dose of lipid-lowering drugs was not stable within 30 days before signing the ICF
• Participated in any clinical trial within 30 days prior to randomization or within 5 half-lives (whichever is older) after the last administration of the investigational drug in the clinical trial (except those who signed ICF and did not receive drug or device intervention)

Sponsors & Collaborators

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

Study Sites (1)

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230000, China

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Wei Hu, Doctor

  The Second Hospital of Anhui Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: October 15, 2024
• Study Start: June 20, 2024
• Primary Completion: December 27, 2024
• Study Completion: February 14, 2025
• Last Updated: December 16, 2025

Record last verified: 2024-07

Locations

CN (1)