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

Phase 1

Completed

• Conditions: Overweight; Healthy; Obese
• Interventions: Drug: LB64640; Drug: Placebo

• Registration Number: NCT06040372
• Lead Sponsor: LG Chem

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.

Study Timeline

• Study Start: 2020-03-16
• Primary Completion: 2022-03-30
• Study Completion: 2022-07-30
• Study First Submitted: 2023-08-21
• Status Verified: 2023-09
• Study First Submitted QC: 2023-09-13
• Last Update Submitted: 2023-09-13
• Study First Posted: 2023-09-15
• Last Update Posted: 2023-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LB54640	LB64640	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
Placebo	Placebo	matching placebo

Primary Outcome Measures

Name	Time	Method
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))
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)

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics profiles in urine for single ascending dose cohort	Through study completion upto 1week depending on cohorts	Amount of unchanged drug excreted into urine (Ae) for specific collection intervals
Pharmacokinetics profiles in Plasma for single ascending dose cohort	Through study completion upto 1week during the single ascending dose cohort	Terminal half-life (t1/2)
Pharmacokinetics profiles in plasma for multiple ascending dose cohort	Through study completion upto 2weeks	Area under the concentration-time curve (AUC) during the dosing periods

Trial Locations

Locations (1)

Clinical Research Unit; 🇺🇸 Chula Vista, California, United States