Clinical trial NCT06040372: A First in Human Study to Assess the Safety, Tolerability of LB54640 in in Healthy Overweight and Obese Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obese
Overweight
Healthy
Lead sponsor: LG Chem
Sponsor class: INDUSTRY
First posted: 2023-09-15
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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 subjects
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence and severity of adverse events (AEs)
timeFrame: Through study completion upto 6weeks depending on cohorts
measure: Incidence and severity of adverse events of special interest (AESIs) in Part 2 (MAD)
timeFrame: Through study completion upto 6weeks depending on cohorts
measure: Change from baseline in vital signs (blood pressure)
timeFrame: Through study completion upto 6weeks depending on cohorts
measure: Change from baseline in vital signs (heart rate)
timeFrame: Through study completion upto 6weeks depending on cohorts
measure: Change from baseline in vital signs (weight in kilograms, height in meters)
timeFrame: Through study completion upto 6weeks depending on cohorts
Secondary outcomes:
measure: Pharmacokinetics profiles in Plasma for single ascending dose cohort
timeFrame: Through study completion upto 1week
measure: Pharmacokinetics profiles in Plasma for single ascending dose cohort
timeFrame: Upto 1week
measure: Pharmacokinetics profiles in Plasma for single ascending dose cohort
timeFrame: Through study completion upto 1week during the single ascending dose cohort
measure: Pharmacokinetics profiles in urine for single ascending dose cohort
timeFrame: upto 1week
measure: Pharmacokinetics profiles in urine for single ascending dose cohort
timeFrame: Through study completion upto 1week depending on cohorts
measure: Pharmacokinetics profiles in plasma for multiple ascending dose cohort
timeFrame: upto 2weeks
measure: Pharmacokinetics profiles in plasma for multiple ascending dose cohort
timeFrame: Through study completion upto 2weeks
Other outcomes:
measure: Effect of food by Pharmacokinetics profiles
timeFrame: Through study completion upto 1week
Locations:
city: Chula Vista
country: United States
facility: Clinical Research Unit
state: California
Study officials:
affiliation: Clinical Research Unit
name: Victoria Mirza
role: PRINCIPAL_INVESTIGATOR
References: