Healthy, Obese, Overweight
Conditions
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 effect of food. Part 2 (Multiple Ascending Dose) This part included 7 sequential dose cohorts (M1-M7), enrolling 8 subjects per cohort. Cohorts was evaluate safety, Pharmacokinetics and Pharmacodynamics parameters in healthy overweight and obese subjects. They were dosed once daily for 28 days with LB54640 or placebo.
Interventions
DRUGLB64640
The investigational product (IP) LB54640 is provided 5 mg, 25 mg and 200 mg strengths.
DRUGPlacebo
Placebo is provided as a matching placebo
Sponsors
LG Chem
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double blind, there will be unblinded pharmacist for investigational product distribution.
Intervention model description
This was a randomized, double-blind, placebo-controlled study conducted in two parts. Study Part 1 had a SAD design to investigate the safety, tolerability, and PK of LB54640 administered orally in healthy overweight and obese subjects. Study Part 1 included a cohort (Cohort S3) to assess the effect of food on LB54640, which was conducted with a blinded, placebo-controlled, two-way crossover design. Study Part 2 had a MAD design to investigate the safety, tolerability, PK, and PD of LB54640 administered orally in healthy overweight and obese subjects
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in vital signs (weight in kilograms, height in meters) | Through study completion upto 6weeks depending on cohorts | weight and height will be combined to report BMI in kg/m\^2 |
| Incidence and severity of adverse events (AEs) | Through study completion upto 6weeks depending on cohorts | Number of subjects who experienced adverse events and severity of adverse events |
| Incidence and severity of adverse events of special interest (AESIs) in Part 2 (MAD) | Through study completion upto 6weeks depending on cohorts | Number of subjects who experienced adverse events of special interest (AESIs) |
| Change from baseline in vital signs (blood pressure) | Through study completion upto 6weeks depending on cohorts | Absolute values and changes from baseline (BP assessed by 24-hour ambulatory blood pressure monitoring (ABPM);systolic pressure and diastolic pressure will be assessed |
| Change from baseline in vital signs (heart rate) | Through study completion upto 6weeks depending on cohorts | Absolute values and changes from baseline (HR assessed by 24-hour ambulatory electrocardiography monitoring (12-lead cardiac telemetry; central reader)) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics profiles in Plasma for single ascending dose cohort | Through study completion upto 1week | Peak Plasma Concentration (Cmax) during the dosing periods |
| Pharmacokinetics profiles in urine for single ascending dose cohort | upto 1week | Renal clearance (CLR) |
| Pharmacokinetics profiles in plasma for multiple ascending dose cohort | upto 2weeks | Maximum concentration (Cmax) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Effect of food by Pharmacokinetics profiles | Through study completion upto 1week | Area under the concentration-time curve (AUC) (total and various incremental AUCs, including AUClast, AUC0-infinity) |
Countries
United States
Outcome results
None listed