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New treatment option for Overweight and Obese Volunteers
Official title Evaluate LAE102 in Healthy and Overweight/Obese Subjects
ClinicalTrials.gov ID: NCT06493084
What this study is testing
What is LAE102 intravenous administration?
LAE102 intravenous administration is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for overweight and obese volunteers.
Also referred to as LAE102 IV.
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
- The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of LAE102 injection in healthy and overweight/obese participants, and also evaluate the preliminary pharmacodynamic effect of multiple dose injections in overweight/obese participants.
- 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 65. Healthy volunteers may be eligible.
You may be able to join if
- Male or female and aged 18 to 65 years (inclusive) at the screening visit
- Male Body weight ≥ 50 kg, female Body weight ≥ 45 kg. For Part A\&B, 18.5 ≤ BMI ≤ 28 kg/m². For part C, 26.0 ≤ BMI ≤ 40.0 kg/m²
- Negative for human immunodeficiency virus antibody (HIV-Ab).
- Female people with no childbearing potential or with childbearing potential which serum human chorionic gonadotropin (hCG) test must \<5mIU/mL .
- Male people are not allowed to donate sperm during this trial.
You likely can't join if
- With clinically significant abnormalities in vital signs, physical examination, ECG or laboratory test results specified in the protocol.
- Allergy to the investigational drug or its excipients, or a history of severe allergy (including any food or drug allergies).
- Self-reported weight change is more than 5% in the previous 3 months prior to screening.
- Diagnosed with secondary overweight or obesity.
- Any clinically significant medical conditions and any diseases affecting the safety of the subject or the determination of study results.
- History of major diseases or physical conditions in the central nervous system, respiratory system, cardiovascular system, digestive system, blood...
See the full eligibility criteria
- Male or female and aged 18 to 65 years (inclusive) at the screening visit
- Male Body weight ≥ 50 kg, female Body weight ≥ 45 kg. For Part A\&B, 18.5 ≤ BMI ≤ 28 kg/m². For part C, 26.0 ≤ BMI ≤ 40.0 kg/m²
- Negative for human immunodeficiency virus antibody (HIV-Ab).
- Female people with no childbearing potential or with childbearing potential which serum human chorionic gonadotropin (hCG) test must \<5mIU/mL .
- Male people are not allowed to donate sperm during this trial.
- Voluntarily participate in the study and provide a signed and dated informed consent form.
- Willing to comply with the scheduled visits, study treatment, laboratory tests, and other study-related procedures and requirements as stipulated in the study protocol.
- With clinically significant abnormalities in vital signs, physical examination, ECG or laboratory test results specified in the protocol.
- Allergy to the investigational drug or its excipients, or a history of severe allergy (including any food or drug allergies).
- Self-reported weight change is more than 5% in the previous 3 months prior to screening.
- Diagnosed with secondary overweight or obesity.
- Any clinically significant medical conditions and any diseases affecting the safety of the subject or the determination of study results.
- History of major diseases or physical conditions in the central nervous system, respiratory system, cardiovascular system, digestive system, blood system, endocrine system, musculoskeletal diseases, mental illness...
- Positive for hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCV-Ab), or syphilis spirochete antibody (TP-Ab).
- Known or suspected history of substance abuse or positive drug screening test.
- Alcohol abuse within 1 year before screening or positive alcohol breath test at baseline.
- Smoking more than 5 cigarettes per day within 3 months before screening, or unable to comply with the prohibition of smoking during the study period.
- Received any vaccine within 30 days prior to screening, or planned to receive any vaccine during the study period.
- Inability to ensure no use of any drugs, including prescription and non-prescription drugs (excluding paracetamol, ibuprofen, and topically applied eye/nasal drops and ointments with no systemic exposure risk)...
- Participated in any clinical trial and received an investigational medicine or medical device within 3 months prior to dosing of the investigational product.
- Underwent major surgery within 30 days before the initial administration or planned to undergo major surgery during the study period.
- Donated blood or experienced blood loss ≥400 mL within 3 months before screening or received a blood transfusion.
- Have special dietary requirements and cannot comply with a standardized diet.
- History of fainting or syncope.
- Dieting or receiving weight loss treatment within 30 days before the initial administration or experiencing major changes in lifestyle.
- Use of GLP-1 receptor agonists, or weight loss medications or systemic corticosteroids (oral or intravenous for more than 7 days), or psychiatric medications within 3 months prior to the initial administration...
- Regular engaged in muscle strength related exercise, applicable to part C.
- Other situation that the investigator considers not appropriate.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, 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 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, 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.