Status:
COMPLETED
A First in Human Study to Assess the Safety, Tolerability of LB54640 in in Healthy Overweight and Obese Subjects
Lead Sponsor:
LG Chem
Conditions:
Obese
Overweight
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
The aim of this 4-weeks randomized double-blind placebo-controlled single and multiple ascending dose study is to assess the Safety and Tolerability of LB54640 in Healthy overweight and obese subjects
Detailed Description
The study was conducted in 2 parts: Part 1 (Single Ascending Dose) This study part included 6 sequential dose cohorts (S1-S6), enrolling 8 healthy subjects per cohort. Cohort S3 was evaluate the effe...
Eligibility Criteria
Inclusion
- Adults ≥ 18 to ≤ 70 years.
- Body mass index (BMI) ≥ 27 kg/m2, with stable body weight by history for 3 months (defined as change \< 5%)
- HbA1c \< 6.5%.
- Female subjects must be non-pregnant and non-lactating. Females of childbearing potential must use at least two of the medically accepted contraceptive methods, table at least 4 weeks prior to the screening.
- Ability to provide written informed consent.
Exclusion
- History or current diagnosis with T1DM or T2DM.
- History or current diagnosis of any malignancy.
- History of pheochromocytoma or insulinoma.
- History or current diagnosis of cardiac dysrhythmias or heart disease
- History of surgical treatment for obesity or any other gastrointestinal surgery
- History of major depression, anxiety, suicidal behavior or attempts, or other psychiatric disorder.
- Use of approved weight-lowering pharmacotherapy
- Has a clinically significant history of suicidal ideation or suicidal behavior as assessed
Key Trial Info
Start Date :
March 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2022
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT06040372
Start Date
March 16 2020
End Date
July 30 2022
Last Update
September 15 2023
Active Locations (1)
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1
Clinical Research Unit
Chula Vista, California, United States, 91911