A First in Human Study to Assess the Safety, Tolerability of LB54640 in in Healthy Overweight and Obese Subjects

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06040372
• Other study ID #: LG-MCCL001
• Status: Completed
• Phase: Phase 1
• Start date: March 16, 2020
• Est. completion date: July 30, 2022

Study information

• Verified date: September 2023
• Source: LG Chem
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: July 30, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Obese
• Overweight

Intervention

Drug:
• LB64640
The investigational product (IP) LB54640 is provided 5 mg, 25 mg and 200 mg strengths.
• Placebo
Placebo is provided as a matching placebo

Locations

Country	Name	City	State
United States	Clinical Research Unit	Chula Vista	California

Sponsors (1)

Lead Sponsor	Collaborator
LG Chem

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Effect of food by Pharmacokinetics profiles	Area under the concentration-time curve (AUC) (total and various incremental AUCs, including AUClast, AUC0-infinity)	Through study completion upto 1week
Primary	Incidence and severity of adverse events (AEs)	Number of subjects who experienced adverse events and severity of adverse events	Through study completion upto 6weeks depending on cohorts
Primary	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)	Through study completion upto 6weeks depending on cohorts
Primary	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	Through study completion upto 6weeks depending on cohorts
Primary	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))	Through study completion upto 6weeks depending on cohorts
Primary	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	Through study completion upto 6weeks depending on cohorts
Secondary	Pharmacokinetics profiles in Plasma for single ascending dose cohort	Peak Plasma Concentration (Cmax) during the dosing periods	Through study completion upto 1week
Secondary	Pharmacokinetics profiles in Plasma for single ascending dose cohort	Area under the plasma concentration versus time curve (AUC)	Upto 1week
Secondary	Pharmacokinetics profiles in Plasma for single ascending dose cohort	Terminal half-life (t1/2)	Through study completion upto 1week during the single ascending dose cohort
Secondary	Pharmacokinetics profiles in urine for single ascending dose cohort	Renal clearance (CLR)	upto 1week
Secondary	Pharmacokinetics profiles in urine for single ascending dose cohort	Amount of unchanged drug excreted into urine (Ae) for specific collection intervals	Through study completion upto 1week depending on cohorts
Secondary	Pharmacokinetics profiles in plasma for multiple ascending dose cohort	Maximum concentration (Cmax)	upto 2weeks
Secondary	Pharmacokinetics profiles in plasma for multiple ascending dose cohort	Area under the concentration-time curve (AUC) during the dosing periods	Through study completion upto 2weeks