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.
Sponsored by Laekna Limited · Phase 1, Interventional, and Basic science
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.
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.
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 →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 →
Inclusion Criteria:
Age at the time of signing the ICF:
at screening:
For female participants:
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).
Type of participant and disease characteristics
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.
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:
Age at the time of signing the ICF:
BMI at screening:
For female participants:
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:
Have a history or presence of clinically significant medical condition(s) including, but not limited to, any
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.
Have a history of any within the past 5 years other than
Have an estimated (eGFR) calculated by chronic kidney diseaseepidemiology (CKD-EPI) creatinine 2021 equation
Have
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:
Show evidence at screening of:
Have
Engaged in regular weightlifting, fitness, or strength training aimed at enhancing muscle strength.
Prior/Concomitant Therapy
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:
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 previously completed or withdrawn from this study or any other study investigating this study intervention.
Lifestyle Considerations
Have
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
Are
Note: A positive result for cotinine is non-exclusionary.
Are
Other Exclusion Criteria
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.
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.
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.
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.
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
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.
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 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 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.
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.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LAE103 injection, subcutaneous (SC) injection
Drug: LAE103 injection
Saline
Drug: Saline
LAE102 injection combined with LAE103 injection, subcutaneous (SC) injection
Drug: LAE102 injection in combined with LAE103 injection
LAE102 injection without active ingredredient combined with saline injection, subcutaneous (SC) injection
Combination Product: 102 placebo + saline
subcutaneous injection of LAE103 alone
LAE102 injection in combined with LAE103 injection via subcutaneous
Saline via subcutaneous
LAE102 injection without active ingredient combined with saline injection
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.
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.
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.
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.
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.
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.
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Laekna Limited