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

• Sponsor: LG Chem (Industry)
• Overall Status: Completed
• CT.gov ID: NCT06040372
• Collaborator: (none)
• Enrollment: 112
• Location: 1
• Arms: 2
• Actual Duration (Months): 28.5
• Patients Per Site Per Month: 3.9

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Obese; Overweight; Healthy	Drug: LB64640; Drug: Placebo	Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 112 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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 subjectsThis 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: Double (Participant, Investigator)
• Masking Description: Double blind, there will be unblinded pharmacist for investigational product distribution.
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Mar 16, 2020
• Actual Primary Completion Date: Mar 30, 2022
• Actual Study Completion Date: Jul 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LB54640 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; The investigational product (IP) LB54640 is provided 5 mg, 25 mg and 200 mg strengths.
Placebo Comparator: Placebo matching placebo	Drug: Placebo; Placebo is provided as a matching placebo

Outcome Measures

Primary Outcome Measures

1. 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

2. 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)

3. 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

4. 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))

5. 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

Secondary Outcome Measures

1. Pharmacokinetics profiles in Plasma for single ascending dose cohort [Through study completion upto 1week]

   Peak Plasma Concentration (Cmax) during the dosing periods

2. Pharmacokinetics profiles in Plasma for single ascending dose cohort [Upto 1week]

   Area under the plasma concentration versus time curve (AUC)

3. 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)

4. Pharmacokinetics profiles in urine for single ascending dose cohort [upto 1week]

   Renal clearance (CLR)

5. 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

6. Pharmacokinetics profiles in plasma for multiple ascending dose cohort [upto 2weeks]

   Maximum concentration (Cmax)

7. 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

Other Outcome Measures

1. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Research Unit	Chula Vista	California	United States	91911

Sponsors and Collaborators

• LG Chem

Investigators

• Principal Investigator: Victoria Mirza, Clinical Research Unit

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: LG Chem
• ClinicalTrials.gov Identifier: NCT06040372
• Other Study ID Numbers: LG-MCCL001
• First Posted: Sep 15, 2023
• Last Update Posted: Sep 15, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Overweight

Study Results

No Results Posted as of Sep 15, 2023