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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorLaekna Limited

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.

Eligibility criteria

Qualifiers

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) .

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • LAE103 injection
  • LAE102 injection in combined with LAE103 injection
  • Saline

Treatment groups

104 Participants
are divided into 3 treatment groups

Sponsors and collaborators