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New treatment option for Obesity
Official title A Study of SHR-2906 Injection in Healthy Subjects With a Single Dose and in Obese Patients With Multiple Doses
ClinicalTrials.gov ID: NCT07280936
What this study is testing
What is SHR-2906 Injection?
SHR-2906 Injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for obesity.
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 study is a randomized, double-blind, placebo-controlled, dose-escalation phase I clinical trial. This study consists of two parts: the single-dose escalation study (SAD) in healthy subjects and the multiple-dose escalation study (MAD) in obese patients.
- Phase 1: an early, usually small safety 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 to 55. Healthy volunteers may be eligible.
You may be able to join if
- Voluntarily sign the informed consent form prior to any study-related activities, understand the procedures and methods of the study, and agree to...
- Males or females aged 18-55 years (inclusive);
- people who are generally healthy as judged by the investigator based on medical history, vital signs, physical examination, laboratory tests, and...
- At screening, 19.0 ≤ BMI ≤ 23.9 kg/m2 (inclusive) for Part I or 28.0 ≤ BMI ≤ 35.0 kg/m2 (inclusive) for Part II.
You likely can't join if
- During screening, electrocardiogram (ECG) indicated that QTcF\>450 ms in males and QTcF\> 470 ms in females, as well as other abnormal ECG and vital...
- There are endocrine diseases or medical histories that may significantly affect body weight during screening (such as Cushing's syndrome, diabetes...
- There is a history or family history of medullary thyroid carcinoma, multiple endocrine adenomatosis type 2, or a history of pancreatitis or...
- Other clinical findings within 12 months prior to screening that show clinical significance in the following diseases (including but not limited to...
- Use of prescription drugs (excluding topical eye/nasal drops and creams without systemic exposure risk), over-the-counter drugs, food supplements...
- Having undergone gastrointestinal surgery that may cause malabsorption before screening, or having taken drugs that directly affect gastrointestinal...
See the full eligibility criteria
- Voluntarily sign the informed consent form prior to any study-related activities, understand the procedures and methods of the study, and agree to complete this study in strict accordance with the clinical study...
- Males or females aged 18-55 years (inclusive);
- people who are generally healthy as judged by the investigator based on medical history, vital signs, physical examination, laboratory tests, and electrocardiogram (ECG);
- At screening, 19.0 ≤ BMI ≤ 23.9 kg/m2 (inclusive) for Part I or 28.0 ≤ BMI ≤ 35.0 kg/m2 (inclusive) for Part II.
- During screening, electrocardiogram (ECG) indicated that QTcF\>450 ms in males and QTcF\> 470 ms in females, as well as other abnormal ECG and vital signs that were judged by the researchers to have clinical...
- There are endocrine diseases or medical histories that may significantly affect body weight during screening (such as Cushing's syndrome, diabetes, hypothyroidism or hyperthyroidism, etc.);
- There is a history or family history of medullary thyroid carcinoma, multiple endocrine adenomatosis type 2, or a history of pancreatitis or symptomatic gallbladder disease;
- Other clinical findings within 12 months prior to screening that show clinical significance in the following diseases (including but not limited to gastrointestinal, kidney, liver, nervous, blood, endocrine, tumor...
- Use of prescription drugs (excluding topical eye/nasal drops and creams without systemic exposure risk), over-the-counter drugs, food supplements, vitamins and Chinese herbal medicines (excluding conventional vitamins)...
- Having undergone gastrointestinal surgery that may cause malabsorption before screening, or having taken drugs that directly affect gastrointestinal peristalsis for a long time. For example: having undergone bariatric...
- Those who have a history of drug abuse in the past five years or have used drugs in the three months prior to the trial; Or the urine drug screening is positive;
- Blood donation of ≥200 mL within one month prior to screening; Or those who have donated ≥400 mL of blood or lost ≥400 mL of blood within 3 months prior to screening due to trauma or major surgical operations;
- Inability to tolerate venipuncture for blood collection or fainting at the sight of needles and blood;
- There are special dietary requirements and they cannot follow the uniform diet;
- people who the researchers consider to have other factors that make them unsuitable for participating in this trial.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, 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 to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, 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.