ClinicalTrials.gg
RecruitingNCT07230496Updated Sep 21, 2026

A Study to Investigate Safety, Tolerability and Pharmacokinetics of LAE103 or LAE103 in Combination With LAE102 in Healthy Overweight/Obese Participants

A Phase 1 interventional study of LAE103 injection and LAE102 injection in combined with LAE103 injection in Overweight and Obesity, sponsored by Laekna Limited. Recruiting at 2 sites in Australia. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-21.

Primary conditionObesityRegistry: OverweightReclassifiedWhy we changed it
Registry
Overweight — the first condition term the registry derived for this study.
ClinicalTrials.gg
Obesity
Why
  1. The study's listed conditions name Obesity, a narrower term within Overweight.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Laekna Limited · Phase 1, Interventional, and Basic science

From the registry’s dates

  • Started Dec 2025; still recruiting 10 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
104
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of LAE103 injection in healthy overweight/obese participants or healthy postmenopausal women. Study will also evaluate the safety, tolerability and preliminary pharmacodynamic effect of multiple dose injections in overweight/obese participants.

In addition, the study will also investigate the safety, tolerability of a single-dose co-administration of LAE102 and LAE103 in healthy overweight/obese participants.

Read the detailed description

This is a randomized, double-blind study comprising of a single-dose escalation study in healthy overweight/obese participants (Part A), a single dose study in healthy postmenopausal women (Part B), and a multiple-dose escalation study in healthy overweight/obese participants (Part C), designed to evaluate the safety, tolerability, Pharmacokinetics (PK )and pharmacodynamics (PD) profiles of LAE103 administered alone.

In addition, the study will also investigate the safety, tolerability, and PK/PD profiles of a single-dose co-administration of LAE102 and LAE103 in healthy overweight/obese participants (Part D).

About 104 participants will be enrolled in 13 cohorts with each cohort including 8 participants randomized 6:2 study drug:Placebo.

02

Conditions studied

  • Overweight and Obesity

Browse trials for

03

In context

Obesity Reclassified

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's planned enrollment of 104 is above the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Laekna Limited is the lead sponsor of 11 studies on the registry; 3 are open to participants now.

Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Overweight. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria:

  1. : Are capable of giving signed informed consent and comply with the requirements and restrictions listed in the ICF and in this protocol.
  2. Age at the time of signing the ICF:

    1. Parts A, C, and D: Male or female participants aged 18 to 55 years, inclusive. Each cohort must include at least 3 female and 3 male participants.
    2. Part B: Female participants aged 45 to 75 years, inclusive.
  3. at screening:

    1. Parts A, C, and D: Have a BMI within the range of 25.0 to 40.0 kg/m2 (inclusive).
    2. Part B: Have a BMI within the range of 20.0 to 40.0 kg/m2 (inclusive).
  4. For female participants:

    1. Participants without : defined as either or surgically sterile: including surgical sterilization (recorded bilateral salpingectomy, hysterectomy, or bilateral oophorectomy at least 6 weeks before screening visit); postmenopausal women defined as an individual who has had at least 12 months of spontaneous amenorrhea without an alternative medical cause and a FSH level in the postmenopausal range (≥ 40 IU/L at screening), or
    2. Participants with childbearing potential, non-pregnant, non-lactating, must agree to use two forms of effective methods of (at least one form must be highly effective) for the duration of the study, and 130 days after the last product administration. During this period, participants should not donate eggs. Serum hCG test must \< 5 mIU/mL at both the screening visit and D-1. Hormonal contraceptives should be commenced one month prior to screening to ensure contraceptive is in full effect.

    Complete abstinence is acceptable if it is part of the participant's usual and preferred lifestyle. Participants who are in same-sex relationships and continuously not heterosexually active are exempt from contraceptive requirements. However, WOCBP must still undergo pregnancy testing as per protocol (This would only apply to Parts A, C, and D, details of contraception guidance refer to 12.3).

  5. Male participants with female partners of childbearing potential must agree to use adequate methods of contraception, which is defined as use of a condom by the male partner combined with use of a highly effective method of contraception by the female partner for the duration of the study and for 130 days after the last dosing. Male participants are not allowed to donate sperm for the same period. Hormonal contraceptives used by the female partner should have commenced one month prior to screening to ensure contraceptive is in full effect.
  6. Type of participant and disease characteristics

    1. Are overtly healthy participants, as determined by medical evaluation including medical history, physical examination, laboratory tests, and .
    2. Have FSH levels ≥ 40 IU/L at screening (Part B only).
    3. Have liver function tests and all other clinical laboratory tests results within the normal range for the population, or results deemed not at the discretion of the investigator.

      Note: except for minor deviation judged to be acceptable by the investigator. Retesting may occur once during the screening visit at the discretion of the investigator.

    4. Have venous access sufficient to allow for blood sampling as per the protocol or have no anticipated to receiving investigational products via SC delivery.
  7. Are willing to make themselves available for study visits for the duration of the study and are willing to follow study procedures.

Note: For Part D optional cohort, inclusion criteria for the additional 2 postmenopausal women can be referred to Part B if their enrollment is planned

Exclusion Criteria:

  1. Informed consent: Are capable of giving signed informed consent and comply with the requirements and restrictions listed in the ICF and in this protocol.
  2. Age at the time of signing the ICF:

    1. Parts A, C, and D: Male or female participants aged 18 to 55 years, inclusive. Each cohort must include at least 3 female and 3 male participants.
    2. Part B: Female participants aged 45 to 75 years, inclusive.
  3. BMI at screening:

    1. Parts A, C, and D: Have a BMI within the range of 25.0 to 40.0 kg/m2 (inclusive).
    2. Part B: Have a BMI within the range of 20.0 to 40.0 kg/m2 (inclusive).
  4. For female participants:

    1. Participants without childbearing potential: defined as either postmenopausal or surgically sterile: including surgical sterilization (recorded bilateral salpingectomy, hysterectomy, or bilateral oophorectomy at least 6 weeks before screening visit); postmenopausal women defined as an individual who has had at least 12 months of spontaneous amenorrhea without an alternative medical cause and a FSH level in the postmenopausal range (≥ 40 IU/L at screening), or
    2. Participants with childbearing potential, non-pregnant, non-lactating, must agree to use two forms of effective methods of contraception (at least one form must be highly effective) for the duration of the study, and 130 days after the last investigational product administration. During this period, participants should not donate eggs. Serum hCG test must \< 5 mIU/mL at both the screening visit and D-1. Hormonal contraceptives should be commenced one month prior to screening to ensure contraceptive is in full effect.

Complete abstinence is acceptable if it is part of the participant's usual and preferred lifestyle. Participants who are in same-sex relationships and continuously not heterosexually active are exempt from contraceptive requirements. However, WOCBP must still undergo pregnancy testing as per protocol (This would only apply to Parts A, C, and D, details of contraception guidance refer to 12.3). LAEKNA LAE103INT1001 Protocol Version 5.0/2026.08.31 CONFIDENTIAL Page 74 of 1455) Male participants with female partners of childbearing potential must agree to use adequate methods of contraception, which is defined as use of a condom by the male partner combined with use of a highly effective method of contraception by the female partner for the duration of the study and for 130 days after the last dosing. Male participants are not allowed to donate sperm for the same period. Hormonal contraceptives used by the female partner should have commenced one month prior to screening to ensure contraceptive is in full effect.

6) Type of participant and disease characteristics

a) Are overtly healthy participants, as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECG. b) Have FSH levels ≥ 40 IU/L at screening (Part B only). c) Have liver function tests and all other clinical laboratory tests results within the normal range for the population, or results deemed not clinically significant at the discretion of the investigator. Note: except for minor deviation judged to be acceptable by the investigator. Retesting may occur once during the screening visit at the discretion of the investigator. d) Have venous access sufficient to allow for blood sampling as per the protocol or have no anticipated contraindications to receiving investigational products via SC delivery.

7) Are willing to make themselves available for study visits for the duration of the study and are willing to follow study procedures. Note: For Part D optional cohort, inclusion criteria for the additional 2 postmenopausal women can be referred to Part B if their enrollment is planned

Exclusion Criteria:

Medical Conditions:

  1. Have a history or presence of clinically significant medical condition(s) including, but not limited to, any

    1. cardiovascular, cerebrovascular, gastrointestinal (including hepatic) diseases.
    2. diabetes, or (HbA1c) ≥ 6.5% or fasting blood glucose ≥ 7.0 mmol/L, medullary thyroid carcinoma, type 2 multiple endocrine neoplasia, chronic pancreatitis, and thyroid disorders.

      Note: Participants who have been on steady dose of thyroid replacement therapy for at least 90 days prior to screening, can be included in the study.

    3. conditions affecting skin, respiratory, cardiovascular, digestive, renal, blood, endocrine,reproductive system.
    4. diagnosed with secondary overweight or obesity, such as obesity caused by metabolic diseases (such as Cushing's syndrome, hypothyroidism, etc.) or drug-induced obesity(such as , tricyclic antidepressants, atypical antipsychotic drugs, etc.).
    5. psychiatric or neurological disease.
    6. neuromuscular disorder including, but not limited to multiple sclerosis, myasthenia gravis, myopathy, peripheral neuropathy, muscular dystrophy, or amyotrophic lateral sclerosis.
    7. inflammatory or diseases that may cause muscle wasting, including, but not limited to systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA).
    8. inflammatory myopathies, including but not limited to polymyositis or dermatomyositis.
    9. other disease, abnormality or physiological conditions that would pose an unacceptable risk to study participants or confound the interpretation of the data collected during the study.
    10. individuals who have had a diagnosis of acute pancreatitis.
    11. individuals who have self-perceived dullness or loss of sensation on either side of their abdomen; or have, in the investigator's opinion, excessive tattoos or scars over the arm, thigh, abdomen or other factors (for example rash, excessive fold of skin) that, would interfere with injection-site assessments.
  2. Have a history of any within the past 5 years other than

    1. basal cell or squamous epithelial carcinomas in situ,
    2. cervical carcinoma in situ that have been resected with no evidence of diseases for 3 years.
  3. Have a fasting serum triglyceride level of more than 500 mg/dL(5.6 mmol/L) at screening.
  4. Have an estimated (eGFR) calculated by chronic kidney diseaseepidemiology (CKD-EPI) creatinine 2021 equation

    1. less than 90 mL/min/1.73 m2 at screening for Part A, C, and Part D
    2. less than 60 mL/min/1.73 m2 at screening for Part B. Note: Creatine level within normal range, or out of the normal range but deemed nonclinically significant by the investigator can be enrolled.
  5. Have

    1. an abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risks associated with participating in the study, or
    2. confirmed supine Fridericia's (QTcF) interval greater than 450 msec for males and greater than 470 msec for females at screening.

    Note: A mean value will be used to assess the exclusion criterion when triplicate measurements will be made as per protocol.

  6. Have an abnormal blood pressure defined as:

    1. diastolic blood pressure greater than 90 mmHg, or less than 50 mmHg
    2. systolic blood pressure greater than 140 mmHg, or less than 90 mmHg Note: except for minor deviation judged to be acceptable by the investigator, or mild to moderate hypertension that is well-controlled with no more than one antihypertensive medication and no changes to hypertension medication within the last three months. Retesting may occur once during the screening visit at the discretion of the investigator.
  7. Show evidence at screening of:

    1. (HIV) or positive human HIV antibodies
    2. or positive hepatitis C antibodies
    3. or positive hepatitis B surface antigen.
  8. Have

    1. a history of, or known to study intervention or its , or
    2. a history of, or know hypersensitivity to monoclonal antibody drugs, or
    3. a history of any severe allergies (including any food or drug allergies).
  9. Underwent major surgery within 30 days prior to study intervention administration or plan to undergo major surgery during the study.
  10. Self-reported weight change is more than 5% in the previous 3 months prior to screening.
  11. Engaged in regular weightlifting, fitness, or strength training aimed at enhancing muscle strength.

    Prior/Concomitant Therapy

  12. Use of GLP-1 receptor agonists, or weight loss medications such as orlistat, naltrexone/bupropion, or systemic corticosteroids (oral or intravenous for more than 7 days), or psychiatric medications (e.g., tricyclic antidepressants, olanzapine) within 3 months prior to the first dose of the investigational product.
  13. Have used in the past 90 days (before screening) or intend to use during the study any medication that may affect FSH levels, including but not limited to:

    1. hormonal replacement therapy (except for topical vaginal administration)
    2. systemic corticosteroids therapy longer than 2 weeks, or
    3. growth hormone therapies.
  14. Have used or intend to use prescription or over the counter medications, or herbal medicines, from 7 days or 5 half-lives (if known), whichever is longer, prior to study intervention administration until the last visit.

    Note: Occasional paracetamol/acetaminophen (up to 2 g/day), vitamins (at recommended daily doses, and approved by the investigator), ibuprofen (up to 0.4 g/day), topically applied eye, or nasal drops and ointments with no clinically significant systemic exposure are allowed.

  15. Received any vaccine 30 days prior to screening or plan to receive any vaccine during the study.

    Prior/Concurrent Clinical Study Experience

  16. Have participated, are currently enrolled in, or discontinued from a clinical trial involving an investigational drug or device or off-label use of a drug or device within the last 30 days, or 5-half-lives (if known, whichever is longer), of the last administration of study drug or application of the device, or any other type of medical research judged not to be scientifically or medically compatible with this study.
  17. Have previously completed or withdrawn from this study or any other study investigating this study intervention.

    Lifestyle Considerations

  18. Have

    1. an average weekly alcohol consumption exceeding 14 units per week for female participants, 21 units per week for male participants, or
    2. positive alcohol test at screening or admission, or
    3. a history of alcohol abuse disorder within 1 year prior to screening, or
    4. an inability or unwillingness to stop alcohol consumption 7 days prior to dosing.

    Note: 1 unit of alcohol is defined as 12 oz (360 mL) of beer, 5 oz (150 mL) of wine, or 1.5 oz (45 mL) of distilled spirits. Repeated alcohol breath testing within 24 hours are permitted at investigator's discretion.

  19. Have

    1. known or suspected history of substance abuse (such as morphine, methamphetamine, ketamine, methylenedioxyamphetamine, tetrahydrocannabinol) deemed clinically significant by the investigator, or
    2. test positive for drugs of abuse at screening or admission. Note: Repeated DOA testing within 24 hours are permitted at investigator's discretion.
  20. Are

    1. smoking more than 5 cigarettes (or the equivalent of other tobacco products) per day within 90 days prior to screening, or
    2. unable or unwilling to stop smoking tobacco products during the confinement peirod.

    Note: A positive result for cotinine is non-exclusionary.

  21. Have donated blood or experienced blood loss of more than 400 mL within 30 days prior to screening.
  22. Are

    1. fasting or receiving weight loss treatment within 30 days prior to study intervention administration, or
    2. experiencing major changes in lifestyle (e.g., abrupt initiation of a dietary regimens or an augmenting physical activities aiming to lose weight).

    Other Exclusion Criteria

  23. In the opinion of the investigator or Sponsor and medical monitor, are unsuitable for inclusion in the study.
  24. Are Laekna Limited. employees, CRO employees, investigator, or site personnel directly affiliated with this study or the immediate families of any of these. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
  25. Have contraindications for MRI scan or do not meet the requirements for MRI scan as per local guideline. (This criterion applies only to Parts C and D.)
Terms in these criteria, in plain language(21)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
104 participants (estimated)

Study arms

  • Experimental
    Treatment arm of single drug

    LAE103 injection, subcutaneous (SC) injection

    Drug: LAE103 injection

  • Placebo comparator
    comparator arm

    Saline

    Drug: Saline

  • Experimental
    Treatment arm of combination

    LAE102 injection combined with LAE103 injection, subcutaneous (SC) injection

    Drug: LAE102 injection in combined with LAE103 injection

  • Placebo comparator
    102 placebo+ saline

    LAE102 injection without active ingredredient combined with saline injection, subcutaneous (SC) injection

    Combination Product: 102 placebo + saline

Interventions

  • DrugLAE103 injection

    subcutaneous injection of LAE103 alone

  • DrugLAE102 injection in combined with LAE103 injection

    LAE102 injection in combined with LAE103 injection via subcutaneous

  • DrugSaline

    Saline via subcutaneous

  • Combination product102 placebo + saline

    LAE102 injection without active ingredient combined with saline injection

06

What researchers measure

Primary outcomes

  1. Number & severity of participants with treatment-related adverse events

    Findings on physical examination, ECG, vital signs, and reports of the laboratory results via investigator assessment

    Time frame: From Day1 to Day112 for single dose part.From Day1 to Day84 for Combination Drug Part. From Day 1 to Day140 for multiple dose part.

Secondary outcomes

  1. characterize the peak of serum concentration (Cmax)

    evaluate the maximum observed serum concentration(Cmax) via LAE103 injection mono or LAE102 combined with LAE103 injection

    Time frame: From Day1 to Day112 for single dose part.From Day1 to Day 84 for Combination Drug Part. From Day 1 to Day140 for multiple dose part.

  2. characterize the time of reaching peak of serum concentration (Tmax)

    evaluate what time to reach the maximum serum concentration(Tmax)

    Time frame: From Day1 to Day112 for single dose part.From Day 1 to Day 84 for Combination Drug Part. From Day 1 to Day140 for multiple dose part.

  3. characterize the area under the serum concentration versus time curve (AUC)

    Evaluate the area under the serum concentration versus time curve (AUC) in LAE103 mono injection or LAE102 combined with LAE103 injection

    Time frame: From Day1 to Day112 for single dose part.From Day1 to Day 84 for Combination Drug Part. From Day 1 to Day140 for multiple dose part.

  4. Evaluate the expression levels of Activin A in blood samples

    The validated methodology was employed to assay serum levels of Activin A in biological samples.

    Time frame: From Day1 to Day112 for single dose part.From Day 1 to Day 84 for Combination Drug Part. From Day 1 to Day140 for multiple dose part.

  5. Incidence of positive Anti-drug antibody(ADA) after administration

    Test ADA status in biological sample via validated methodology

    Time frame: From Day1 to Day112 for single dose part.From Day1 to Day 84 for Combination Drug Part. From Day 1 to Day140 for multiple dose part.

07

Study locations

1 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07230496
Lead sponsor
Laekna Limited
Responsible party
Sponsor
First posted
Nov 17, 2025
Start date
Dec 30, 2025
Primary completion
Mar 20, 2028 (estimated)
Completion
Mar 20, 2028 (estimated)
Last update
Sep 21, 2026

Study contacts

Juan Liu
Contact
juan.liu@laekna.com
1-858-374-2717

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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