Actively Recruiting
A Study to Evaluate Features of KN069 in Participants With Obesity or Overweight
Led by Suzhou Alphamab Co., Ltd. · Updated on 2025-09-17
36
Participants Needed
1
Research Sites
151 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Evaluate Features of KN069 in Participants With Obesity or Overweight
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male, 18-55 years old (including threshold)
- Body mass index (BMI) between 24.0 kg/m2 and less than 35 kg/m2
- HbA1c less than 6.5%
- Fasting blood glucose level between 3.9 mmol/L and less than 7.0 mmol/L
- Willing and able to follow study procedures and restrictions and sign informed consent form
You will not qualify if you...
- History of chronic diseases or current obvious systemic diseases including cardiovascular, respiratory, endocrine, metabolic, urinary, digestive, blood, autoimmune, neurological, psychiatric, bacterial or viral infections
- History of acute or chronic pancreatitis; personal or family history of medullary thyroid cancer or multiple endocrine adenoma syndrome type 2; history of other malignancies
- History of gastrointestinal disorders impacting gastric emptying or aggravated by GLP-1 analogs or DPP-IV inhibitors
- Past cholecystolithiasis or cholecystectomy
- Allergies to KN069 excipients or similar drugs
- History of medicine or narcotics abuse within 1 year prior to screening or positive drug screening
- Major surgery within 3 months prior to screening or planned during trial
- Excessive alcohol consumption over 14 units per week within 3 months before or during screening
- Blood donation or loss of 300 mL or more within 3 months prior to screening or planned donation during or 1 month after trial
- Participation in other clinical trials or drug/vaccine administration within 2 months prior to screening
- Weight loss treatment or significant lifestyle changes within 2 months prior to dosing
- Vaccinations within 14 days prior to screening or planned during trial
- Use of medication except vitamin/mineral supplements, paracetamol, topical medication, contraceptives within 14 days prior to dosing
- Use of GLP-1 analogues, receptor agonists or related drugs within 3 months prior to administration
- Abnormal liver enzymes, bilirubin, triglycerides, or other clinically significant abnormalities
- Positive breath test for alcohol
- Evidence of hepatitis B, C, HIV, or syphilis
- Positive urine drug screen
- Refusal to abstain from pregnancy or use effective birth control during study and 3 months after dosing
- Plans to donate sperm from dosing until 3 months after administration
- Abdominal skin unsuitable for subcutaneous injection due to trauma, surgery, allergies, or lesions
- Other factors deemed unacceptable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Actively Recruiting
Research Team
Y
Yanrong Dong, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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