A Study to Investigate Safety, Tolerability and Pharmacokinetics of LAE103 or LAE103 in Combinati… (NCT07230496) | Clinical Trial Compass
RecruitingPhase 1
A Study to Investigate Safety, Tolerability and Pharmacokinetics of LAE103 or LAE103 in Combination With LAE102 in Healthy Overweight/Obese Participants
Australia104 participantsStarted 2025-12-30
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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 f…
What they're measuring
1
Number & severity of participants with treatment-related adverse events
Timeframe: From Day1 to Day70 for single dose part. From Day 1 to Day98 for multiple dose part