Overweight and ObesityPhase 1NCT07230496
A Study to Investigate Safety, Tolerability and Pharmacokinetics of LAE103 or LAE103 in Combination With LAE102 in Healthy Overweight/Obese Participants
A Phase 1 study testing LAE103 injection, LAE102 injection in combined with LAE103 injection and Saline in people with Overweight and Obesity, run by Laekna Limited at 2 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- LAE103 injection, LAE102 injection in combined with LAE103 injection and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 2 sitesAustralia
- Study dates
- 30 Dec 2025to 20 Mar 2028
- Phase
- Phase 1
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Informed consent: Are capable of giving signed informed consent and comply with the requirements and restrictions listed in the ICF and in this protocol.
- Age at the time of signing the ICF:
- 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.
- Part B: Female participants aged 45 to 75 years, inclusive.
- BMI at screening:
- Parts A, C, and D: Have a BMI within the range of 25.0 to 40.0 kg/m2 (inclusive).
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- Part B: Have a BMI within the range of 20.0 to 40.0 kg/m2 (inclusive).
- For female participants:
- 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
- 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).
- 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.
- Type of participant and disease characteristics
- Are overtly healthy participants, as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECG.
- Have FSH levels ≥ 40 IU/L at screening (Part B only).
- 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.
- 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.
- 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
Who cannot join
- Informed consent: Are capable of giving signed informed consent and comply with the requirements and restrictions listed in the ICF and in this protocol.
- Age at the time of signing the ICF:
- 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.
- Part B: Female participants aged 45 to 75 years, inclusive.
- BMI at screening:
- Parts A, C, and D: Have a BMI within the range of 25.0 to 40.0 kg/m2 (inclusive).
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- Part B: Have a BMI within the range of 20.0 to 40.0 kg/m2 (inclusive).
- For female participants:
- 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
- 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
- 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
- Medical Conditions:
- Have a history or presence of clinically significant medical condition(s) including, but not limited to, any
- cardiovascular, cerebrovascular, gastrointestinal (including hepatic) diseases.
- diabetes, or glycated hemoglobin (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.
- conditions affecting skin, respiratory, cardiovascular, digestive, renal, blood, endocrine,reproductive system.
- 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 glucocorticoids, tricyclic antidepressants, atypical antipsychotic drugs, etc.).
- psychiatric or neurological disease.
- neuromuscular disorder including, but not limited to multiple sclerosis, myasthenia gravis, myopathy, peripheral neuropathy, muscular dystrophy, or amyotrophic lateral sclerosis.
- inflammatory or autoimmune diseases that may cause muscle wasting, including, but not limited to systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA).
- inflammatory myopathies, including but not limited to polymyositis or dermatomyositis.
- 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.
- individuals who have had a diagnosis of acute pancreatitis.
- 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.
- Have a history of any malignancy within the past 5 years other than
- basal cell or squamous epithelial carcinomas in situ,
- cervical carcinoma in situ that have been resected with no evidence of metastatic diseases for 3 years.
- Have a fasting serum triglyceride level of more than 500 mg/dL(5.6 mmol/L) at screening.
- Have an estimated glomerular filtration rate (eGFR) calculated by chronic kidney diseaseepidemiology (CKD-EPI) creatinine 2021 equation
- less than 90 mL/min/1.73 m2 at screening for Part A, C, and Part D
- 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.
- Have
- an abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risks associated with participating in the study, or
- confirmed supine Fridericia's corrected QT (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.
- Have an abnormal blood pressure defined as:
- diastolic blood pressure greater than 90 mmHg, or less than 50 mmHg
- 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.
- Show evidence at screening of:
- human immunodeficiency virus (HIV) or positive human HIV antibodies
- hepatitis C or positive hepatitis C antibodies
- hepatitis B or positive hepatitis B surface antigen.
- Have
- a history of, or known hypersensitivity to study intervention or its excipients, or
- a history of, or know hypersensitivity to monoclonal antibody drugs, or
- a history of any severe allergies (including any food or drug allergies).
- Underwent major surgery within 30 days prior to study intervention administration or plan to undergo major surgery during the study.
- Self-reported weight change is more than 5% in the previous 3 months prior to screening.
- Engaged in regular weightlifting, fitness, or strength training aimed at enhancing muscle strength.
- Prior/Concomitant Therapy
- 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.
- 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:
- hormonal replacement therapy (except for topical vaginal administration)
- systemic corticosteroids therapy longer than 2 weeks, or
- growth hormone therapies.
- 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.
- Received any vaccine 30 days prior to screening or plan to receive any vaccine during the study.
- Prior/Concurrent Clinical Study Experience
- 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.
- Have previously completed or withdrawn from this study or any other study investigating this study intervention.
- Lifestyle Considerations
- Have
- an average weekly alcohol consumption exceeding 14 units per week for female participants, 21 units per week for male participants, or
- positive alcohol test at screening or admission, or
- a history of alcohol abuse disorder within 1 year prior to screening, or
- 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.
- Have
- known or suspected history of substance abuse (such as morphine, methamphetamine, ketamine, methylenedioxyamphetamine, tetrahydrocannabinol) deemed clinically significant by the investigator, or
- test positive for drugs of abuse at screening or admission. Note: Repeated DOA testing within 24 hours are permitted at investigator's discretion.
- Are
- smoking more than 5 cigarettes (or the equivalent of other tobacco products) per day within 90 days prior to screening, or
- unable or unwilling to stop smoking tobacco products during the confinement peirod.
- Note: A positive result for cotinine is non-exclusionary.
- Have donated blood or experienced blood loss of more than 400 mL within 30 days prior to screening.
- Are
- fasting or receiving weight loss treatment within 30 days prior to study intervention administration, or
- 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
- In the opinion of the investigator or Sponsor and medical monitor, are unsuitable for inclusion in the study.
- 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.
- 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.)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia2 sites, 2 recruiting
- Recruiting
Q-Pharm Pty Ltd.
Brisbane, Queensland, 4006
+61 737072720, m.wong@nucleusnetwork.com.au
- Not yet recruiting
Nucleus Network Pty Ltd
Sydney, New South Wales, 2065
Joseph Taylor, 040 556 4419, j.taylor3@nucleusnetwork.com.au
About this study
Official title: A Phase I, Randomized, Double-blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LAE103 as Single and Multiple Ascending Doses in Healthy Overweight/Obese Participants, and as Single Dose in Healthy Postmenopausal Women, With an Additional Evaluation of Single Ascending Dose of LAE103 in Combination With LAE102 in Healthy Overweight/Obese Participants
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.
- Conditions
- Overweight and Obesity
- Being tested
- LAE103 injection, LAE102 injection in combined with LAE103 injection, Saline, 102 placebo + saline
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAE103 injectionDrug
subcutaneous injection of LAE103 alone
LAE102 injection in combined with LAE103 injectionDrug
LAE102 injection in combined with LAE103 injection via subcutaneous
SalineDrug
Saline via subcutaneous
102 placebo + salineCombination product
LAE102 injection without active ingredient combined with saline injection
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm of single drug | Experimental | LAE103 injection, subcutaneous (SC) injection Receives: Drug: LAE103 injection |
| comparator arm | Placebo comparator | Saline Receives: Drug: Saline |
| Treatment arm of combination | Experimental | LAE102 injection combined with LAE103 injection, subcutaneous (SC) injection Receives: Drug: LAE102 injection in combined with LAE103 injection |
| 102 placebo+ saline | Placebo comparator | LAE102 injection without active ingredredient combined with saline injection, subcutaneous (SC) injection Receives: Combination Product: 102 placebo + saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 (5)
characterize the peak of serum concentration (Cmax)
evaluate the maximum observed serum concentration(Cmax) via LAE103 injection mono or LAE102 combined with LAE103 injection
Measured: 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.
characterize the time of reaching peak of serum concentration (Tmax)
evaluate what time to reach the maximum serum concentration(Tmax)
Measured: 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.
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
Measured: 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.
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.
Measured: 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.
Incidence of positive Anti-drug antibody(ADA) after administration
Test ADA status in biological sample via validated methodology
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start30 Dec 2025
- Primary completion20 Mar 2028 (estimated)
- Study completion20 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laekna Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07230496
- Sponsor's protocol ID
- LAE103INT1001
- Status last verified
- Sep 2026
- First submitted
- 13 Nov 2025
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No