Evaluating HDM1005 Injection for Overweight and Obesity
A Randomized, Double-blind, Placebo-controlled, Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Subcutaneous (SC) Doses of HDM1005 Injection in Overweight or Obese Subjects
This study is testing a new injection called HDM1005 to see if it can help people who are overweight or obese lose weight safely.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 1 site (Hefei, Anhui) |
| Trial ID | NCT06637020 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a randomized, double-blind, placebo-controlled study designed to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of HDM1005 injection in overweight or obese individuals. It consists of five dose cohorts, each with ten participants, who will receive either the injection or a placebo in a 4:1 ratio. The study will escalate doses based on safety data collected over a 14-day period, allowing for careful monitoring and adjustment of dosages as needed. The aim is to determine the optimal dosing strategy for this new treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 65 with a BMI between 27.0 and 40.0 kg/m².
Not a fit: Patients with severe obesity (BMI > 40.0 kg/m²) or those with uncontrolled health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for individuals struggling with overweight and obesity.
How similar studies have performed: While this approach is novel, similar studies targeting obesity have shown promise in the past, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion criteria 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) * Any of the auxiliary test indicators during the screening period meets the following criteria: a) Hemoglobin \<100g/L for women and \< 110g/L for men; b) ALT\>2.0x upper limit of normal (ULN), or AST\>2.0x ULN, or ALP\>1.5x ULN, or TBIL\>1.5x ULN (Subjects with Gilbert's syndrome can participate in this study if DBIL≤ULN); c) HbA1c≥6.5%, or fasting blood glucose ≥7.0 mmol/L or ≤3.9 mmol/L; d) Triglyceride \>5.6 mmol/L; e) calcitonin ≥20 ng/L; f) Thyroid stimulating hormone \>6.0 mIU/L or \<0.4 mIU/L g) blood amylase or lipase \>ULN; h)eGFR \< 90 mL/min/1.73m2; i) QTcF Male \>450ms, female \>470ms * People tested positive for infectious diseases * Habitual smokers, alcoholics and drug abusers * Blood donors within 3 months prior to randomization * Pregnant or lactating women * The Investigator considers that the subject is not suitable to participate in any other circumstances of the trial
Where this trial is running
Hefei, Anhui
- The Second Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China (Recruiting)
Study contacts
- Principal investigator: Wei Hu, Doctor — The Second Hospital of Anhui Medical University
- Study coordinator: Xu Sun
- Email: sunxu@eastchinapharm.com
- Phone: +86 13645153601
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.