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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: KN069 Dose 1 | Experimental | Participants will receive a single SC KN069 12mg. |
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| Group 2: KN069 Dose 2 | Experimental | Participants will receive a single SC KN069 30mg. |
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| Group 3: KN069 Dose 3 | Experimental | Participants will receive a single SC KN069 60mg. |
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| Group 4: KN069 Dose 4 | Experimental | Participants will receive a single SC KN069 120mg. |
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| Group 5: KN069 Dose 5 | Experimental | Participants will receive a single SC KN069 240mg. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KN069 | Drug | Solution for SC injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and severity of adverse events | Up to Day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the plasma concentration of KN069 | Up to Day 42 | |
| To evaluate the Area under the plasma concentration versus time curve (AUC) of KN069 | Up to Day 42 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanrong Dong, Master | Contact | +86 18914005458 | 86 | yanrongdong@alphamab.com |
| Name | Affiliation | Role |
|---|---|---|
| GuoPing Yang, Doctor | Xiangya Third Hospital, Central South University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42010360 | Derived | Xie J, Huang J, Wu Q, Deng K, Yang S, Yang S, Wu S, Yang X, Huang W, Dong Y, Li J, Yang G, Guo C. 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. Diabetes Obes Metab. 2026 Jul;28(7):5848-5859. doi: 10.1111/dom.70794. Epub 2026 Apr 20. |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| To evaluate the weight (kg) change from baseline |
| Up to Day 42 |
| To evaluate the waist circumference (cm) change from baseline | Up to Day 42 |
| To evaluate the BMI (kg/m^2) change from baseline | Up to Day 42 |
| Number of Participants with Anti-KN069 Antibodies | Up to Day 42 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |