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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

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

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

A Study to Evaluate Features of KN069 in Participants With Obesity or Overweight (NCT06547775) is a Phase 1 interventional studying Overweight or Obesity, sponsored by Suzhou Alphamab Co., Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Overweight or Obesity, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 36 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Male, 18-55 years old (including threshold); 2. Body mass index (BMI):24.0 kg/m2≤BMI\<35 kg/m2; 3. HbA1c\<6.5%;3.9mmol/L≤Fasting blood glucose level \<7.0mmol/L; 4. 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. Who Should NOT Join This Trial: 1. 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, digestive system, blood system, autoimmune system, neurological or psychiatric system, bacterial or viral infection; 2. 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; 3. 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 appendectomy) or could be aggravated by GLP-1 analogs or DPP-IV inhibitors; 4. Participants had cholecystolithiasis (removal of gallstones) or cholecystectomy (removal of gall bladder) in the past; 5. Allergies to KN069 excipients or drugs similar to KN069 in structure or KN069 in the same category; 6. 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; 7. 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 surgery is defined as surgery on the intracranial, chest, abdomen, pelvic, or limb organs that result in major tissue trauma and require long-term recovery). ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Male, 18-55 years old (including threshold); 2. Body mass index (BMI):24.0 kg/m2≤BMI\<35 kg/m2; 3. HbA1c\<6.5%;3.9mmol/L≤Fasting blood glucose level \<7.0mmol/L; 4. 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. Exclusion Criteria: 1. 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, digestive system, blood system, autoimmune system, neurological or psychiatric system, bacterial or viral infection; 2. 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; 3. 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 appendectomy) or could be aggravated by GLP-1 analogs or DPP-IV inhibitors; 4. Participants had cholecystolithiasis (removal of gallstones) or cholecystectomy (removal of gall bladder) in the past; 5. Allergies to KN069 excipients or drugs similar to KN069 in structure or KN069 in the same category; 6. 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; 7. 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 surgery is defined as surgery on the intracranial, chest, abdomen, pelvic, or limb organs that result in major tissue trauma and require long-term recovery). 8. 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 stay, and alcohol consumption cannot be limited to less than 2 units of alcohol per day during the post-discharge visit. 9. 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. 10. Received administration of other drugs/vaccines in clinical trials within 2 months prior to screening; In other clinical trials at the time of screening; 11. 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.; 12. 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, RNA vaccine, DNA vaccine, COVID-19 vaccine; 13. 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 dosing. 14. 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. 15. 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 value range by 2 times; Serum total bilirubin (TBIl) exceeded 1.5 times the upper limit of the reference value range; 2) Fasting triglyceride (TG) ≥5.6mmol/L; 3) Physical examination, vital signs, electrocardiogram, laboratory examination, imaging and other abnormalities have clinical significance, and the investigator judges that they may pose a major risk to the subjects or interfere with the evaluation of safety, PK or PD results and are not suitable to participate in the trial; 16. Positive breath test for alcohol (\>0 mg/100 mL); 17. Evidence of hepatitis B/hepatitis C/HIV/syphilis. 18. Urine screen positive for drug abuse. 19. 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 to 3 months after administration of IP; or to have a birth plan during the screening period until 3 months after dosing; 20. Participants that plan to donate sperms from dosing until 3 months after administration of IP. 21. Due to trauma, surgery, allergies or skin lesions, the abdominal skin is not suitable for subcutaneous injection. 22. Other factors that the investigator considers unacceptable for participation in the study.

Treatments Being Tested

DRUG

KN069

Solution for SC injection

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

The Third Xiangya Hospital of Central South University
Changsha, Hunan, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06547775), the sponsor (Suzhou Alphamab Co., Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06547775 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06547775?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06547775?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06547775. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06547775. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.