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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

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

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

A Study to Investigate Safety, Tolerability and Pharmacokinetics of LAE103 or LAE103 in Combination With LAE102 in Healthy Overweight/Obese Participants (NCT07230496) is a Phase 1 interventional studying Overweight and Obesity, sponsored by Laekna Limited. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

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

About This Trial

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.

What Stage of Research Is This?

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

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

Target enrollment of 104 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Overweight and Obesity subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Are capable of giving signed willing to sign a consent form and comply with the requirements and restrictions listed in the ICF and in this protocol. - Male or female participants aged 18 to 55 years in part A, C, D. Female participants aged 45 to 75 years in Part B. - Have a BMI within the range of 25.0 to 40.0 kg/m2 in Parts A, C, and D and a BMI within the range of 20.0 to 35.0 kg/m2 in Part B. - Participants without childbearing potential 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) . - Male participants with female partners of childbearing potential must agree to use adequate methods of contraception. Male subjects are not allowed to donate sperm during this trial. - Are overtly healthy participants or Have FSH levels ≥ 40 IU/L at screening (Part B only). - Are willing to make themselves available for study visits for the duration of the study and are willing to follow study procedures. Who Should NOT Join This Trial: - Have a history or presence of clinically significant medical condition(s). - Have a history of any malignancy within the past 5 years. other than basal cell or squamous epithelial carcinomas in situ and 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. - Estimated glomerular filtration rate (eGFR) less than 90 mL/min/1.73 m2 at screening for Part A, C, and Part D or less than 60 mL/min/1.73 m2 at screening for Part B. - Have an abnormality in the 12-lead ECG to increase risk or QT (QTcF) interval greater than 450 msec at screening. - Have an abnormal blood pressure. - Positive human HIV antibodies or positive hepatitis C antibodies or positive hepatitis B surface antigen. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

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

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Are capable of giving signed informed consent and comply with the requirements and restrictions listed in the ICF and in this protocol. * Male or female participants aged 18 to 55 years in part A, C, D. Female participants aged 45 to 75 years in Part B. * Have a BMI within the range of 25.0 to 40.0 kg/m2 in Parts A, C, and D and a BMI within the range of 20.0 to 35.0 kg/m2 in Part B. * Participants without childbearing potential 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) . * Male participants with female partners of childbearing potential must agree to use adequate methods of contraception. Male subjects are not allowed to donate sperm during this trial. * Are overtly healthy participants or Have FSH levels ≥ 40 IU/L at screening (Part B only). * Are willing to make themselves available for study visits for the duration of the study and are willing to follow study procedures. Exclusion Criteria: * Have a history or presence of clinically significant medical condition(s). * Have a history of any malignancy within the past 5 years. other than basal cell or squamous epithelial carcinomas in situ and 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. * Estimated glomerular filtration rate (eGFR) less than 90 mL/min/1.73 m2 at screening for Part A, C, and Part D or less than 60 mL/min/1.73 m2 at screening for Part B. * Have an abnormality in the 12-lead ECG to increase risk or QT (QTcF) interval greater than 450 msec at screening. * Have an abnormal blood pressure. * Positive human HIV antibodies or positive hepatitis C antibodies or positive hepatitis B surface antigen. * A history of, or known hypersensitivity to antibody drug, study procedure or any severe 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. * Use of GLP-1 receptor agonists, or weight loss medication 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. * Have used or intend to use prescription or over the counter medications, or herbal medicines, from 14 days or 5 half-lives (if known), whichever is longer, prior to study intervention administration until the last visit. * Received any vaccine 30 days prior to screening or plan to receive any vaccine during the study. * 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 90 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. * 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. * Have known or suspected history of substance abuse or test positive for drugs of abuse at screening or admission. * 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 period. * 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. * 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.)

Treatments Being Tested

DRUG

LAE103 injection

subcutaneous injection of LAE103 alone

DRUG

LAE102 injection in combined with LAE103 injection

LAE102 injection in combined with LAE103 injection via subcutaneous

DRUG

Saline

Saline via subcutaneous

Locations (1)

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

Q-Pharm Pty Ltd.
Brisbane, Queensland, Australia

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07230496), the sponsor (Laekna Limited), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

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

Authoritative Sources

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

Frequently Asked Questions

What is the NCT07230496 clinical trial studying?

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

Who can participate in NCT07230496?

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

How do I contact the trial site for NCT07230496?

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

Is participating in a clinical trial safe?

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

Where can I verify the data on this page?

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

How This Page Is Built

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

Source: ClinicalTrials.gov API v2 record for NCT07230496. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07230496. Data: ClinicalTrials.gov."

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

Last updated 2026-05-08 · Data from ClinicalTrials.gov.