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

LG Chem

Status and phase: Completed; Phase 1

Conditions: Healthy; Overweight; Obese

Treatments: Drug: Placebo; Drug: LB64640

Study type: Interventional

Funder types: Industry

Identifiers

NCT06040372

LG-MCCL001

Details and patient eligibility

About

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

Full 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.

Enrollment: 112 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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112 participants in 2 patient groups, including a placebo group

LB54640

Experimental group

Description:

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

Treatment:

Drug: LB64640

Placebo

Placebo Comparator group

Description:

matching placebo

Treatment:

Drug: Placebo