๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
1. Informed consent: Are capable of giving signed informed consent and comply with the requirements and restrictions listed in the ICF and in this protocol.
2. Age at the time of signing the ICF:
1. 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.
2. Part B: Female participants aged 45 to 75 years, inclusive.
3. BMI at screening:
1. Parts A, C, and D: Have a BMI within the range of 25.0 to 40.0 kg/m2 (inclusive).
2. Part B: Have a BMI within the range of 20.0 to 40.0 kg/m2 (inclusive).
4. For female participants:
1. 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 (โฅ 40 IU/L at screening), or
2. 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).
5. 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
1. Are overtly healthy participants, as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECG.
2. Have FSH levels โฅ 40 IU/L at screening (Part B only).
3. 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.
4. 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:
1. Informed consent: Are capable of giving signed informed consent and comply with the requirements and restrictions listed in the ICF and in this protocol.
2. Age at the time of signing the ICF:
1. 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.
2. Part B: Female participants aged 45 to 75 years, inclusive.
3. BMI at screening:
1. Parts A, C, and D: Have a BMI within the range of 25.0 to 40.0 kg/m2 (inclusive).
2. Part B: Have a BMI within the range of 20.0 to 40.0 kg/m2 (inclusive).
4. For female participants:
1. 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 (โฅ 40 IU/L at screening), or
2. 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 c