POMC Deficiency ObesityPhase 2NCT06041841
A Phase 2 Study to Assess Efficacy and Safety of LB54640 in Patients With Genetic Obesity
A Phase 2 study testing LB54640 in people with POMC Deficiency Obesity and PCSK1 Deficiency Obesity, run by LG Chem at 2 sites in 2 countries.
Trial summary
The purpose of the study was to assess the efficacy of LB54640 in participants with rare genetic disorders of obesity Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- POMC Deficiency Obesity, PCSK1 Deficiency Obesity, LEPR Deficiency Obesity
- What is being tested?
- LB54640
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Dec 2023to Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants aged ≥12 years at the time of enrollment and diagnosed with genetic obesity due to POMC, PCSK1, or LEPR deficiency mutations.
- Obesity is defined as BMI ≥30 kg/m2 for participants ≥18 years of age or BMI ≥95th percentile for age and gender for participants <18 years of age.
Who cannot join
- Participants with recent (within 2 months, prior to Screening and up to enrollment) intensive diet/exercise regimen that resulted in >2% weight loss, use of medication to treat obesity (within 3 months of first dose of LB54640 with certain exceptions), or weight loss surgery within 6 months prior to Screening or prior surgery which resulted in >10% weight loss with no evidence of weight regain are excluded
- History of major surgical procedure
- Weight loss surgery within the previous 6 months
- Any history of a suicide attempt, or any suicidal behavior
- HbA1c >10.9%
- Fasting glucose level >270 mg/dL
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Phase 2, Single-arm, Open-label Study to Assess Efficacy and Safety of LB54640 in Patients With Obesity Due to POMC, PCSK1, or LEPR Deficiency.
The purpose of the study was to assess the efficacy of LB54640 in participants with rare genetic disorders of obesity
Read the detailed description
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.
- Being tested
- LB54640
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LB54640Drug
LB54640 QD Oral
| Study group | Role | What they receive |
|---|---|---|
| POMC/PCSK1/LEPR cohort | Experimental | LB54640 once daily by oral administration Receives: Drug: LB54640 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of BMI
Measured: From baseline to Week 16
Secondary outcomes (6)
Frequency and severity of adverse events (AE)
Measured: From first dose up to Week 52
Frequency and severity of adverse events of special interest (AESI)
Measured: From first dose up to Week 52
Mean change and mean percentage change from baseline in body weight
Measured: From baseline up to Week 52
Mean change and mean percentage change from baseline in waist circumference.
Measured: 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).
Measured: 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
Measured: From baseline up to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study startDec 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for POMC Deficiency ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a study where each participant participates for up to 56 weeks. The study consists up to 7 visits to study center which include a Screening period, treatment period, and a follow-up period. Eligible participants who are willing to enter the long-term extension period and who are judged by the study doctor to have no safety concerns, will continue to receive LB54640 at the same dose level from the treatment period. The long-term extension period will be followed by a follow-up period
- Masking
- None (open label)
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LG Chem
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06041841
- Sponsor's protocol ID
- LG-MCCL004
- Status last verified
- Oct 2023
- First submitted
- 11 Sep 2023
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Single-arm, Open-label Study to Assess Efficacy and Safety of LB54640 in Patients With Obesity Due to POMC, PCSK1, or LEPR Deficiency.
- ClinicalTrials.gov ID
- NCT06041841
- Acronym / sponsor ID
- LG-MCCL004
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- LG ChemIndustry (pharma, biotech, devices)
- Study start
- Dec 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 18 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study was to assess the efficacy of LB54640 in participants with rare genetic disorders of obesity
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a study where each participant participates for up to 56 weeks. The study consists up to 7 visits to study center which include a Screening period, treatment period, and a follow-up period. Eligible participants who are willing to enter the long-term extension period and who are judged by the study doctor to have no safety concerns, will continue to receive LB54640 at the same dose level from the treatment period. The long-term extension period will be followed by a follow-up period
| Arm | Type | Receives |
|---|---|---|
| POMC/PCSK1/LEPR cohort | Experimental | Drug: LB54640LB54640 once daily by oral administration |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Participants aged ≥12 years at the time of enrollment and diagnosed with genetic obesity due to POMC, PCSK1, or LEPR deficiency mutations.
- Obesity is defined as BMI ≥30 kg/m2 for participants ≥18 years of age or BMI ≥95th percentile for age and gender for participants <18 years of age.
Key exclusion criteria (6 listed)
- Participants with recent (within 2 months, prior to Screening and up to enrollment) intensive diet/exercise regimen that resulted in >2% weight loss, use of medication to treat obesity (within 3 months of first dose of LB54640 with certain exceptions), or weight loss surgery within 6 months prior to Screening or prior surgery which resulted in >10% weight loss with no evidence of weight regain are excluded
- History of major surgical procedure
- Weight loss surgery within the previous 6 months
- Any history of a suicide attempt, or any suicidal behavior
- HbA1c >10.9%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LB54640LB54640 QD Oral | Drug | POMC/PCSK1/LEPR cohort |
Primary outcome
Change of BMI
Time frame: From baseline to Week 16
6 secondary outcomes
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
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
Time frame: From baseline up to Week 52
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for POMC Deficiency Obesity
Active, not recruitingObservational study
Early Check: Expanded Screening in Newborns
Spinal Muscular Atrophy, Fragile X Syndrome
Active, not recruitingObservational study
Early Genetic Identification of Obesity
Obesity, Childhood, Hyperphagia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LB54640 in people with POMC Deficiency Obesity and PCSK1 Deficiency Obesity, run by LG Chem at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact LG CHEM (+82-2-3777-1114, pathway@lgchem.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of BMI (time frame: From baseline to Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2023.