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Tests treatment safety and results for Obesity & Overweight
Official title Efficacy and Safety of HDM1005 in Chinese Obesity or Overweight Patients Without Diabetes
ClinicalTrials.gov ID: NCT07279194
What this study is testing
What is HDM1005 1?
HDM1005 1 is an investigational medicine, given as an once-weekly, being studied as a potential treatment for obesity & overweight.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a 56-week randomized, double blinded, parallel-controlled study evaluating the efficacy andsafety of the HDM1005 in patients with obesity or overweight. Eligible participants will be screened and randomized to different dose group of HDM1005 or the placebo group at a ratio of 1:1:1 , HDM1005 or placebo will be given once weekly for 52 weeks, following by a safety follow up of 4 weeks.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female, aged ≥18 years at the time of signing informed consent.
- BMI≥28 kg/m2 or ≥24 kg/m2 and previously diagnosed with at least one of the following weight related comorbidities: hypertension, dyslipidemia...
- A self-reported change in body weight no more than 5% within 90 days before screening.
- Able to understand the procedures and methods of this study, willing to strictly comply with the clinical trial protocol to complete this trial, and...
You likely can't join if
- Have type 1 diabetes mellitus (T1DM) or T2DM.
- Have HbA1c≥6.5% or fasting serum glucose (FSG)≥7.0 mmol/L at Visit 1.
- Have obesity induced by other endocrinologic disorders (for example, Cushing syndrome) or by other medicine.
- Use of GLP-1 receptor (GLP-1R) agonists or GLP-1R/GCGR agonists or GIPR/GLP-1R agonists or GIPR/GLP-1R/GCGR agonists within 3 months prior to...
- Use of hypoglycemic drugs within 3 months prior to screening.
- History of thyroid C-cell carcinoma, multiple endocrine neoplasia (MEN) 2A or 2B or relevant family history.
See the full eligibility criteria
- Male or female, aged ≥18 years at the time of signing informed consent.
- BMI≥28 kg/m2 or ≥24 kg/m2 and previously diagnosed with at least one of the following weight related comorbidities: hypertension, dyslipidemia, pre-diabetes, obstructive sleep apnea, fatty liver, weight-bearing joint...
- A self-reported change in body weight no more than 5% within 90 days before screening.
- Able to understand the procedures and methods of this study, willing to strictly comply with the clinical trial protocol to complete this trial, and voluntarily sign the informed consent form.
- Have type 1 diabetes mellitus (T1DM) or T2DM.
- Have HbA1c≥6.5% or fasting serum glucose (FSG)≥7.0 mmol/L at Visit 1.
- Have obesity induced by other endocrinologic disorders (for example, Cushing syndrome) or by other medicine.
- Use of GLP-1 receptor (GLP-1R) agonists or GLP-1R/GCGR agonists or GIPR/GLP-1R agonists or GIPR/GLP-1R/GCGR agonists within 3 months prior to screening.
- Use of hypoglycemic drugs within 3 months prior to screening.
- History of thyroid C-cell carcinoma, multiple endocrine neoplasia (MEN) 2A or 2B or relevant family history.
- Previous history of acute and chronic pancreatitis, acute gallbladder disease history (except cholecystectomy) history.
- PHQ questionnaire ≥ 15 points at screening or randomization.
- Have had a history of moderate to severe depression; Or have a history of severe mental illness in the past.
- Uncontrolled hypertension prior to screening, defined as: systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg (stable for 1 month if using antihypertensive drugs).
- History of malignancy (except cured basal cell carcinoma) in the past 5 years or at the time of screening.
- History of severe cardiovascular or cerebrovascular diseases within the past six months.
- History of alcohol and drug abuse at screening.
- The participant may be allergic to ingredients in the study drug or drugs of the same class.
- Pregnant or lactating females, males or females of childbearing potential not willing to use contraception throughout the study.
- The subject has any other factors that may affect the how well it works or safety evaluation of this study, and is not suitable for participation in this study in the opinion of the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.