BridgeMD
New treatment option for Overweight or Obesity
Official title A Study to Evaluate Features of KN069 in Participants With Obesity or Overweight
ClinicalTrials.gov ID: NCT06547775
What this study is testing
What is KN069?
KN069 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for overweight or 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 is a Phase 1, First-in-human, double-blinded, placebo-controlled study which aims to investigate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and the immunogenicity of KN069 in Chinese male participants with Obesity or Overweight.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug. 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, men only. Healthy volunteers may be eligible.
You may be able to join if
- Male, 18-55 years old (including threshold);
- Body mass index (BMI)：24.0 kg/m2≤BMI\<35 kg/m2；
- HbA1c\<6.5%；3.9mmol/L≤Fasting blood glucose level \<7.0mmol/L；
- Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures and are willing to...
You likely can't join if
- Those who have a history of chronic diseases or are currently suffering from obvious systemic diseases, such as diseases of cardiovascular system...
- History of acute or chronic pancreatitis; A personal or family history of medullary thyroid cancer or multiple endocrine adenoma syndrome type 2; A...
- History of GI disorder (for example, relevant esophageal reflux or gall bladder disease) or any GI disease which impacts gastric emptying (for...
- Participants had cholecystolithiasis (removal of gallstones) or cholecystectomy (removal of gall bladder) in the past;
- Allergies to KN069 excipients or drugs similar to KN069 in structure or KN069 in the same category;
- A history of medicine abuse/dependence or narcotics abuse within 1 year prior to the screening and/or show positive findings on urinary drug...
See the full eligibility criteria
- Male, 18-55 years old (including threshold);
- Body mass index (BMI)：24.0 kg/m2≤BMI\<35 kg/m2；
- HbA1c\<6.5%；3.9mmol/L≤Fasting blood glucose level \<7.0mmol/L；
- Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures and are willing to follow study restrictions; Are able and willing to sign the ICF.
- Those who have a history of chronic diseases or are currently suffering from obvious systemic diseases, such as diseases of cardiovascular system, respiratory system, endocrine and metabolic system, urinary system...
- History of acute or chronic pancreatitis; A personal or family history of medullary thyroid cancer or multiple endocrine adenoma syndrome type 2; A history of other malignancies;
- History of GI disorder (for example, relevant esophageal reflux or gall bladder disease) or any GI disease which impacts gastric emptying (for example, gastric bypass surgery, pyloric stenosis, with the exception of...
- Participants had cholecystolithiasis (removal of gallstones) or cholecystectomy (removal of gall bladder) in the past;
- Allergies to KN069 excipients or drugs similar to KN069 in structure or KN069 in the same category;
- A history of medicine abuse/dependence or narcotics abuse within 1 year prior to the screening and/or show positive findings on urinary drug screening;
- Have undergone any major surgery or surgery affecting drug absorption, distribution, metabolism, excretion within the 3 months prior to screening, or are scheduled to undergo surgery during the trial period (major...
- Drinking more than 14 units of alcohol per week (1 unit =360ml beer or 45ml liquor with 40% alcohol or 150ml wine) in the 3 months before or during the screening period, alcohol cannot be banned during the hospital...
- Blood donation or blood loss ≥ 300 mL within 3 months prior to screening, or blood/blood components donation planned during the trial or within 1 month after the final study visit.
- Received administration of other drugs/vaccines in clinical trials within 2 months prior to screening; In other clinical trials at the time of screening;
- People who diet or undergo weight loss treatment within 2 months (for whatever reason) before administration, or who have made significant changes in their lifestyle habits.;
- Received vaccination within 14 days prior to screening, or have vaccination schedule during the trial, including inactivated vaccine, live attenuated vaccine, recombinant protein vaccine, recombinant adenovirus vaccine...
- Use medication (including prescription drugs, over-the-counter drugs, herbal medicine) with the exception of vitamin/mineral supplements, paracetamol, topical medication, and contraceptives within 14 days prior to...
- Use of GLP-1 analogues, GLP-1 receptor agonists, or any other formulations related to incretin and other drugs that the investigator believes may affect the trial within the 3 months prior to administration.
- Any abnormal patients who met the following criteria during screening: 1) serum alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) exceeded the upper limit of the reference...
- Positive breath test for alcohol (\>0 mg/100 mL);
- Evidence of hepatitis B/hepatitis C/HIV/syphilis.
- Urine screen positive for drug abuse.
- Participants that refuse to stay abstinent, and refuse to consistently use a form of highly effective birth control method starting at Screening (signing the ICF) and continuing throughout the clinical study period, and...
- Participants that plan to donate sperms from dosing until 3 months after administration of IP.
- Due to trauma, surgery, allergies or skin lesions, the abdominal skin is not suitable for subcutaneous injection.
- Other factors that the investigator considers unacceptable for participation in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Changsha, Hunan, 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 male, 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 Changsha, Hunan, 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.