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Overweight or ObesityPhase 1NCT06547775

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

A Phase 1 study testing KN069 in people with Overweight or Obesity, run by Suzhou Alphamab Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Overweight or Obesity
What is being tested?
KN069
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteChina
Study dates
2 Aug 2024to 30 Jun 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
  • 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 appendectomy) or could be aggravated by GLP-1 analogs or DPP-IV inhibitors;
  • 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;
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  • 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).
  • 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.
  • 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, RNA vaccine, DNA vaccine, COVID-19 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 dosing.
  • 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 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;
  • 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 to 3 months after administration of IP; or to have a birth plan during the screening period until 3 months after dosing;
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yanrong Dong, Master contact

+86 18914005458 ext. 86

yanrongdong@alphamab.com

China1 site, 1 recruiting

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan

    Guoping Yang, doctor, +86-0731-89918665, ygp9880@163.com

    Recruiting

Other trials in China

About this study

Official title: 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

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.

Being tested
KN069
Medical subject headings
Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KN069Drug

    Solution for SC injection

Study groups in NCT06547775
Study groupRoleWhat they receive
Group 1: KN069 Dose 1ExperimentalParticipants will receive a single SC KN069 12mg.
Receives: Drug: KN069
Group 2: KN069 Dose 2ExperimentalParticipants will receive a single SC KN069 30mg.
Receives: Drug: KN069
Group 3: KN069 Dose 3ExperimentalParticipants will receive a single SC KN069 60mg.
Receives: Drug: KN069
Group 4: KN069 Dose 4ExperimentalParticipants will receive a single SC KN069 120mg.
Receives: Drug: KN069
Group 5: KN069 Dose 5ExperimentalParticipants will receive a single SC KN069 240mg.
Receives: Drug: KN069

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency and severity of adverse events

    Measured: Up to Day 42

Secondary outcomes (6)

  1. To evaluate the plasma concentration of KN069

    Measured: Up to Day 42

  2. To evaluate the Area under the plasma concentration versus time curve (AUC) of KN069

    Measured: Up to Day 42

  3. To evaluate the weight (kg) change from baseline

    Measured: Up to Day 42

  4. To evaluate the waist circumference (cm) change from baseline

    Measured: Up to Day 42

  5. To evaluate the BMI (kg/m^2) change from baseline

    Measured: Up to Day 42

  6. Number of Participants with Anti-KN069 Antibodies

    Measured: Up to Day 42

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2024
  2. Study start2 Aug 2024
  3. Primary completion30 Apr 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06547775
Sponsor's protocol ID
KN069-A-101
Status last verified
Sep 2024
First submitted
2 Aug 2024
Last updated
17 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 42010360

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing KN069 in people with Overweight or Obesity, run by Suzhou Alphamab Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yanrong Dong, Master (+86 18914005458 ext. 86, yanrongdong@alphamab.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency and severity of adverse events (time frame: Up to Day 42). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06547775, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.

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