A Phase 2 interventional study of LB54640 in POMC Deficiency Obesity, PCSK1 Deficiency Obesity and LEPR Deficiency Obesity, sponsored by LG Chem. Not yet recruiting at 2 sites in 2 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2023-11-02.
Sponsored by LG Chem · Phase 2, Interventional, and Treatment
The purpose of the study was to assess the efficacy of LB54640 in participants with rare genetic disorders of obesity
Patients with obesity due to POMC, PCSK1 or LEPR deficiency will be enrolled to receive LB54640 by oral administration for 16 weeks. After 16 weeks of treatment, the participant may enter a long term extension phase and receive treatment for up to 1 year.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 4 is below the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →LG Chem is the lead sponsor of 71 studies on the registry; 8 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 1 (8%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LB54640 once daily by oral administration
Drug: LB54640
LB54640 QD Oral
Change of BMI
Time frame: From baseline to Week 16
Frequency and severity of adverse events (AE)
Time frame: From first dose up to Week 52
Frequency and severity of adverse events of special interest (AESI)
Time frame: From first dose up to Week 52
Mean change and mean percentage change from baseline in body weight
Time frame: From baseline up to Week 52
Mean change and mean percentage change from baseline in waist circumference.
Time frame: From baseline up to Week 52
Mean change and mean percentage change from baseline in Hunger Questionnaire Scores
The question will asked using the Hunger Questionnaire. The questionnaire consists of a new 5-item, patient-reported scale assessing major eating-related factors (worst and average hunger, appetite, craving, and satiety).
Time frame: From baseline up to Week 52
Mean change and mean percentage change from baseline in body composition assessed by dual energy x-ray absorptiometry
Fat mass and lean mass will be measured through dual energy x-ray absorptiometry
Time frame: From baseline up to Week 52
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2023; primary completion for Dec 2024, 12 months later.
Of 176 industry-sponsored phase 2 interventional studies under Obesity, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 18. This study's planned 12 months is close to that.
Counting every sponsor, half of 308 studies reached it within 16 months; a quarter within 10 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Bivamelagon