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Recruiting Phase 1 NCT07230496

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

Trial Parameters

Condition Overweight and Obesity
Sponsor Laekna Limited
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 104
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2025-12-30
Completion 2028-03-20
Interventions
LAE103 injectionLAE102 injection in combined with LAE103 injectionSaline

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.

Eligibility Criteria

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 t

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