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

NCT07230496 | Recruiting Phase 1 FDA Drug

• 1 other identifier: LAE103INT1001
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Overweight and Obesity

Outcome Measures

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

  From Day1 to Day70 for single dose part. From Day 1 to Day98 for multiple dose part

Secondary Outcomes (5)

• characterize the peak of serum concentration (Cmax)

  From pre-dose to Day70 for single dose part. From pre-dose to Day98 for multiple dose part

• characterize the time of reaching peak of serum concentration (Tmax)

  From pre-dose to Day70 for single dose part. From pre-dose to Day98 for multiple dose part

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

  From pre-dose to Day70 for single dose part. From pre-dose to Day98 for multiple dose part

• Evaluate the expression levels of Activin A in blood samples

  From pre-dose to Day70 for single dose part. From pre-dose to Day98 for multiple dose part.

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

  From pre-dose to Day70 for single dose part. From pre-dose to Day98 for multiple dose part.

Study Arms (3)

Treatment arm of single drug

EXPERIMENTAL

LAE103 injection, subcutaneous (SC) injection

Drug: LAE103 injection; Drug: Saline

comparator arm

PLACEBO COMPARATOR

Saline

Drug: Saline

Treatment arm of combination

EXPERIMENTAL

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

Drug: LAE102 injection in combined with LAE103 injection; Drug: Saline

Interventions

LAE103 injection DRUG

subcutaneous injection of LAE103 alone

Treatment arm of single drug

LAE102 injection in combined with LAE103 injection DRUG

LAE102 injection in combined with LAE103 injection via subcutaneous

Treatment arm of combination

Saline DRUG

Saline via subcutaneous

Treatment arm of combination; Treatment arm of single drug; comparator arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laekna Limited: lead

Study Sites (1)

Q-Pharm Pty Ltd.

Brisbane, Queensland, 4006, Australia

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Michael Wong

  Q-Pharm Pty Ltd.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan Liu

CONTACT

1-858-374-2717; Juan.liu@laekna.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 17, 2025
• Study Start: December 30, 2025
• Primary Completion (Estimated): March 20, 2028
• Study Completion (Estimated): March 20, 2028
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)