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

Completed · Phase 1 · Has a placebo group

Conditions studied: Obese, Overweight, Healthy

In brief

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

Key facts

Study ID

NCT06040372

Run by

LG Chem

People needed

112

Starts

2020-03-16

Expected to finish

2022-07-30

Last updated by the study team

2023-09-15

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• Clinical Research Unit — Chula Vista, California, United States

Full record on ClinicalTrials.gov

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