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

NCT06040372 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: LG-MCCL001
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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

Conditions

Obese; Overweight; Healthy

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (7)

• Pharmacokinetics profiles in Plasma for single ascending dose cohort

  Through study completion upto 1week

• Pharmacokinetics profiles in Plasma for single ascending dose cohort

  Upto 1week

• Pharmacokinetics profiles in Plasma for single ascending dose cohort

  Through study completion upto 1week during the single ascending dose cohort

• Pharmacokinetics profiles in urine for single ascending dose cohort

  upto 1week

• Pharmacokinetics profiles in urine for single ascending dose cohort

  Through study completion upto 1week depending on cohorts

Other Outcomes (1)

• Effect of food by Pharmacokinetics profiles

  Through study completion upto 1week

Study Arms (2)

LB54640

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

matching placebo

Drug: Placebo

Interventions

LB64640 DRUG

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

LB54640

Placebo DRUG

Placebo is provided as a matching placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• LG Chem: lead

Study Sites (1)

Clinical Research Unit

Chula Vista, California, 91911, United States

Location

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Victoria Mirza

  Clinical Research Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind, there will be unblinded pharmacist for investigational product distribution.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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 subjects

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: September 15, 2023
• Study Start: March 16, 2020
• Primary Completion: March 30, 2022
• Study Completion: July 30, 2022
• Last Updated: September 15, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)