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Completed

NCT Number: NCT06040372

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

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

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Key information

Conditions

Obese Body Weight Healthy Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Research Unit

Chula Vista, California, 91911, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LB64640

Drug

The investigational product (IP) LB54640 is provided 5 mg, 25 mg and 200 mg strengths.

Placebo

Drug

Placebo is provided as a matching placebo

Primary outcomes

  1. Incidence and severity of adverse events (AEs)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: Through study completion upto 6weeks depending on cohorts

    weight and height will be combined to report BMI in kg/m^2

Secondary outcomes

  1. Pharmacokinetics profiles in Plasma for single ascending dose cohort

    Time frame: Through study completion upto 1week

    Peak Plasma Concentration (Cmax) during the dosing periods

  2. Pharmacokinetics profiles in Plasma for single ascending dose cohort

    Time frame: Upto 1week

    Area under the plasma concentration versus time curve (AUC)

  3. Pharmacokinetics profiles in Plasma for single ascending dose cohort

    Time frame: 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

    Time frame: upto 1week

    Renal clearance (CLR)

  5. Pharmacokinetics profiles in urine for single ascending dose cohort

    Time frame: 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

    Time frame: upto 2weeks

    Maximum concentration (Cmax)

  7. Pharmacokinetics profiles in plasma for multiple ascending dose cohort

    Time frame: Through study completion upto 2weeks

    Area under the concentration-time curve (AUC) during the dosing periods

Other outcomes

  1. Effect of food by Pharmacokinetics profiles

    Time frame: Through study completion upto 1week

    Area under the concentration-time curve (AUC) (total and various incremental AUCs, including AUClast, AUC0-infinity)

Sponsors and collaborators

Lead sponsor

LG Chem

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 15, 2023
Registry last updated
Sep 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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