Actively Recruiting

Phase 1
Age: 18Years - 55Years
MALE
Healthy Volunteers
ID06547775

A Randomized, Double-blind and Placebo-controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of KN069 in Chinese Male Participants With Obesity or Overweight

Led by Suzhou Alphamab Co., Ltd. · Updated on 2025-09-17

36

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are conducting a Phase 1 clinical trial to study KN069 in Chinese male participants who are overweight or obese. This first-in-human, double-blind, placebo-controlled study aims to assess the safety, tolerability, how the drug moves through and acts in the body, and the immune response to KN069. The study focuses on men aged 18 to 55 with a body mass index between 24.0 and less than 35 kg/m2, who meet specific health criteria related to blood sugar and overall health. Participants will be randomly assigned to one of several groups to receive a single subcutaneous injection of KN069 at doses ranging from 12mg to 240mg or a placebo. The study includes close monitoring after administration to evaluate the body's reaction to the drug. The trial is designed to collect information on how KN069 is processed in the body and its potential effects on weight and waist size over time. During the study, participants will be monitored for up to 42 days with regular assessments for any side effects, blood tests to measure drug levels, and evaluations of weight, waist circumference, and body mass index changes. Researchers will also test for the presence of antibodies against KN069 to assess immune response. Participants must follow study procedures and restrictions while attending scheduled visits for medical exams and laboratory tests.

CONDITIONS

Brief Title

A Study to Evaluate Features of KN069 in Participants With Obesity or Overweight

Who Can Participate

Age: 18Years - 55Years
MALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male, aged 18 to 55 years (inclusive)
  • 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
  • Able and willing to sign informed consent form
Not Eligible

You will not qualify if you...

  • History of chronic diseases or current systemic diseases including cardiovascular, respiratory, endocrine, metabolic, urinary, digestive, blood, autoimmune, neurological, psychiatric disorders, or 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 affecting gastric emptying or aggravated by GLP-1 analogs or DPP-IV inhibitors
  • Previous gallstones removal or gall bladder removal
  • Allergies to KN069 or similar drugs
  • History of medicine or narcotics abuse within one year or positive drug screening
  • Major surgery affecting drug absorption or metabolism within 3 months or planned during trial
  • Alcohol consumption over 14 units per week during screening or restricted alcohol use during trial
  • Recent blood donation or planned during trial
  • Participation in other clinical trials or recent drug/vaccine administration
  • Recent dieting or weight loss treatment or significant lifestyle changes
  • Recent vaccination or planned vaccination during trial
  • Use of medications except specified exceptions within 14 days prior to dosing
  • Use of GLP-1 related drugs within 3 months prior to dosing
  • Abnormal liver enzymes, bilirubin, triglycerides, or clinically significant abnormalities
  • Positive breath alcohol test
  • Evidence of hepatitis B, C, HIV, or syphilis
  • Positive urine drug screen
  • Refusal to use effective birth control during study and 3 months after dosing
  • Plans to donate sperm during study and 3 months after dosing
  • Abdominal skin unsuitable for subcutaneous injection due to trauma, surgery, allergies, or lesions
  • Other investigator-assessed factors unsuitable for participation

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 42 days

Participants receive a single subcutaneous injection of KN069 at one of five dose levels.

Multiple visits for assessments up to Day 42

Trial Site Locations

Total: 1 location

1

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

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Research Team

Y

Yanrong Dong, Master

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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Published Research Related To This Trial

A Phase 1, Randomised, Double-Blind, Placebo-Controlled Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of KN069 (a Dual GLP-1R Agonist and GIPR Antagonist) in Male Adults With Overweight or Obesity.

Jinlian Xie, Jie Huang, Qian Wu...

https://pubmed.ncbi.nlm.nih.gov/42010360