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: 2

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 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)

  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)

  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)

  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

  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

  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.

Study Arms (4)

Treatment arm of single drug

EXPERIMENTAL

LAE103 injection, subcutaneous (SC) injection

Drug: LAE103 injection

comparator arm

PLACEBO COMPARATOR

Saline

Drug: Saline

Treatment arm of combination

EXPERIMENTAL

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

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

Combination Product: 102 placebo + 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

comparator arm

102 placebo + saline COMBINATION_PRODUCT

LAE102 injection without active ingredient combined with saline injection

102 placebo+ saline

Eligibility Criteria

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

You may qualify if:

• 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).
• 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).

You may not qualify if:

• 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).
• 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.
• \) 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.
• Medical Conditions:
• Have a history or presence of clinically significant medical condition(s) including, but not limited to, any

Sponsors & Collaborators

• Laekna Limited: lead

Study Sites (2)

Nucleus Network Pty Ltd

Sydney, New South Wales, 2065, Australia

NOT YET RECRUITING

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

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: September 21, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)