Back to resultsA First in Human Study to Assess the Safety, Tolerability of LB54640 in in Healthy Overweight and Obese Subjects
Primary Purpose
Obese, Overweight, Healthy
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
LB64640
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Obese
Eligibility Criteria
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
Sites / Locations
- Clinical Research Unit
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
LB54640
Placebo
Arm Description
5 mg, 25 mg and 200 mg strengths Subjects will be administered once daily and duration vary per each cohorts. Single Ascending Dose (SAD) cohorts : 1 day SAD 1 10mg SAD 2 25mg SAD 3 50mg (Food effect cohort) SAD 4 100mg SAD 5 200mg SAD 6 400mg healthy Multiple Ascending Dose (MAD) cohorts: 28days MAD 1 10mg MAD 2 25mg MAD 3 50mg MAD 4 100mg MAD 5 200mg MAD 6 400mg MAD 7 600mg
matching placebo
Outcomes
Primary Outcome Measures
Incidence and severity of adverse events (AEs)
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)
Number of subjects who experienced adverse events of special interest (AESIs)
Change from baseline in vital signs (blood pressure)
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)
Absolute values and changes from baseline (HR assessed by 24-hour ambulatory electrocardiography monitoring (12-lead cardiac telemetry; central reader))
Change from baseline in vital signs (weight in kilograms, height in meters)
weight and height will be combined to report BMI in kg/m^2
Secondary Outcome Measures
Pharmacokinetics profiles in Plasma for single ascending dose cohort
Peak Plasma Concentration (Cmax) during the dosing periods
Pharmacokinetics profiles in Plasma for single ascending dose cohort
Area under the plasma concentration versus time curve (AUC)
Pharmacokinetics profiles in Plasma for single ascending dose cohort
Terminal half-life (t1/2)
Pharmacokinetics profiles in urine for single ascending dose cohort
Renal clearance (CLR)
Pharmacokinetics profiles in urine for single ascending dose cohort
Amount of unchanged drug excreted into urine (Ae) for specific collection intervals
Pharmacokinetics profiles in plasma for multiple ascending dose cohort
Maximum concentration (Cmax)
Pharmacokinetics profiles in plasma for multiple ascending dose cohort
Area under the concentration-time curve (AUC) during the dosing periods
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06040372
Brief Title
A First in Human Study to Assess the Safety, Tolerability of LB54640 in in Healthy Overweight and Obese Subjects
Official Title
Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Assess the Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics of Compound LB54640 in Healthy Overweight and Obese Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
March 16, 2020 (Actual)
Primary Completion Date
March 30, 2022 (Actual)
Study Completion Date
July 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LG Chem
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obese, Overweight, Healthy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
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
Masking
ParticipantInvestigator
Masking Description
Double blind, there will be unblinded pharmacist for investigational product distribution.
Allocation
Randomized
Enrollment
112 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LB54640
Arm Type
Experimental
Arm Description
5 mg, 25 mg and 200 mg strengths
Subjects will be administered once daily and duration vary per each cohorts.
Single Ascending Dose (SAD) cohorts : 1 day
SAD 1 10mg
SAD 2 25mg
SAD 3 50mg (Food effect cohort)
SAD 4 100mg
SAD 5 200mg
SAD 6 400mg
healthy Multiple Ascending Dose (MAD) cohorts: 28days
MAD 1 10mg
MAD 2 25mg
MAD 3 50mg
MAD 4 100mg
MAD 5 200mg
MAD 6 400mg
MAD 7 600mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
matching placebo
Intervention Type
Drug
Intervention Name(s)
LB64640
Intervention Description
The investigational product (IP) LB54640 is provided 5 mg, 25 mg and 200 mg strengths.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo is provided as a matching placebo
Primary Outcome Measure Information:
Title
Incidence and severity of adverse events (AEs)
Description
Number of subjects who experienced adverse events and severity of adverse events
Time Frame
Through study completion upto 6weeks depending on cohorts
Title
Incidence and severity of adverse events of special interest (AESIs) in Part 2 (MAD)
Description
Number of subjects who experienced adverse events of special interest (AESIs)
Time Frame
Through study completion upto 6weeks depending on cohorts
Title
Change from baseline in vital signs (blood pressure)
Description
Absolute values and changes from baseline (BP assessed by 24-hour ambulatory blood pressure monitoring (ABPM);systolic pressure and diastolic pressure will be assessed
Time Frame
Through study completion upto 6weeks depending on cohorts
Title
Change from baseline in vital signs (heart rate)
Description
Absolute values and changes from baseline (HR assessed by 24-hour ambulatory electrocardiography monitoring (12-lead cardiac telemetry; central reader))
Time Frame
Through study completion upto 6weeks depending on cohorts
Title
Change from baseline in vital signs (weight in kilograms, height in meters)
Description
weight and height will be combined to report BMI in kg/m^2
Time Frame
Through study completion upto 6weeks depending on cohorts
Secondary Outcome Measure Information:
Title
Pharmacokinetics profiles in Plasma for single ascending dose cohort
Description
Peak Plasma Concentration (Cmax) during the dosing periods
Time Frame
Through study completion upto 1week
Title
Pharmacokinetics profiles in Plasma for single ascending dose cohort
Description
Area under the plasma concentration versus time curve (AUC)
Time Frame
Upto 1week
Title
Pharmacokinetics profiles in Plasma for single ascending dose cohort
Description
Terminal half-life (t1/2)
Time Frame
Through study completion upto 1week during the single ascending dose cohort
Title
Pharmacokinetics profiles in urine for single ascending dose cohort
Description
Renal clearance (CLR)
Time Frame
upto 1week
Title
Pharmacokinetics profiles in urine for single ascending dose cohort
Description
Amount of unchanged drug excreted into urine (Ae) for specific collection intervals
Time Frame
Through study completion upto 1week depending on cohorts
Title
Pharmacokinetics profiles in plasma for multiple ascending dose cohort
Description
Maximum concentration (Cmax)
Time Frame
upto 2weeks
Title
Pharmacokinetics profiles in plasma for multiple ascending dose cohort
Description
Area under the concentration-time curve (AUC) during the dosing periods
Time Frame
Through study completion upto 2weeks
Other Pre-specified Outcome Measures:
Title
Effect of food by Pharmacokinetics profiles
Description
Area under the concentration-time curve (AUC) (total and various incremental AUCs, including AUClast, AUC0-infinity)
Time Frame
Through study completion upto 1week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victoria Mirza
Organizational Affiliation
Clinical Research Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Research Unit
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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A First in Human Study to Assess the Safety, Tolerability of LB54640 in in Healthy Overweight and Obese Subjects
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