A Phase 1 interventional study of LB64640 and Placebo in Obese, Overweight and Healthy, sponsored by LG Chem. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-15.
Sponsored by LG Chem · Phase 1, Interventional, and Treatment
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
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.
3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.
This study's enrollment of 112 is above the median of 73 across 3,175 interventional studies indexed under Overweight.
Browse Overweight studies →LG Chem is the lead sponsor of 70 studies on the registry; 8 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 1 (8%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Drug: LB64640
matching placebo
Drug: Placebo
The investigational product (IP) LB54640 is provided 5 mg, 25 mg and 200 mg strengths.
Placebo is provided as a matching placebo
Incidence and severity of adverse events (AEs)
Number of subjects who experienced adverse events and severity of adverse events
Time frame: Through study completion upto 6weeks depending on cohorts
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)
Time frame: Through study completion upto 6weeks depending on cohorts
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
Time frame: Through study completion upto 6weeks depending on cohorts
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))
Time frame: Through study completion upto 6weeks depending on cohorts
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
Time frame: Through study completion upto 6weeks depending on cohorts
Pharmacokinetics profiles in Plasma for single ascending dose cohort
Peak Plasma Concentration (Cmax) during the dosing periods
Time frame: Through study completion upto 1week
Pharmacokinetics profiles in Plasma for single ascending dose cohort
Area under the plasma concentration versus time curve (AUC)
Time frame: Upto 1week
Pharmacokinetics profiles in Plasma for single ascending dose cohort
Terminal half-life (t1/2)
Time frame: Through study completion upto 1week during the single ascending dose cohort
Pharmacokinetics profiles in urine for single ascending dose cohort
Renal clearance (CLR)
Time frame: upto 1week
Pharmacokinetics profiles in urine for single ascending dose cohort
Amount of unchanged drug excreted into urine (Ae) for specific collection intervals
Time frame: Through study completion upto 1week depending on cohorts
Pharmacokinetics profiles in plasma for multiple ascending dose cohort
Maximum concentration (Cmax)
Time frame: upto 2weeks
Pharmacokinetics profiles in plasma for multiple ascending dose cohort
Area under the concentration-time curve (AUC) during the dosing periods
Time frame: Through study completion upto 2weeks
Effect of food by Pharmacokinetics profiles
Area under the concentration-time curve (AUC) (total and various incremental AUCs, including AUClast, AUC0-infinity)
Time frame: Through study completion upto 1week
Plan to share: No
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This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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LG Chem