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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-16

Study Completion Date

2022-07-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Obese Overweight Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Double blind, there will be unblinded pharmacist for investigational product distribution.

Study Groups

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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

Group Type EXPERIMENTAL

LB64640

Intervention Type DRUG

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

Placebo

matching placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo is provided as a matching placebo

Interventions

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LB64640

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

Intervention Type DRUG

Placebo

Placebo is provided as a matching placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes