A Phase 2 interventional study of GLWL-01 and Placebo in Prader-Willi Syndrome, sponsored by GLWL Research Inc.. Completed at 7 sites in 2 countries. Open to participants aged 16 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-03-27.
Sponsored by GLWL Research Inc. · Phase 2, Interventional, and Treatment
The aim of this study is to evaluate efficacy, safety, and pharmacokinetics of GLWL-01 in the treatment of patients with Prader-Willi Syndrome (PWS).
Participants will be assigned to one of two treatment sequences (GLWL-01/Placebo or Placebo/GLWL-01), with each sequence consisting of two treatment periods separated by a washout period
144 studies on the registry are indexed under Prader-Willi Syndrome; 23 are open to participants now.
This study's enrollment of 19 is below the median of 30 across 100 interventional studies indexed under Prader-Willi Syndrome.
Browse Prader-Willi Syndrome studies →GLWL Research Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.
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:
Unable to refrain from or anticipates the use of:
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GLWL-01 (450mg) twice a day/ Placebo
Drug: GLWL-01 · Drug: Placebo
Placebo / GLWL-01 (450mg), twice a day
Drug: GLWL-01 · Drug: Placebo
Oral administration of 3 capsules, twice a day
Oral administration of 3 capsules, twice a day
Post-treatment Total Score on the Hyperphagia Questionnaire for Clinical Trials (HQ-CT)
GLWL-01 compared with placebo on the post-treatment HQ-CT score. Total range of score of zero to 36, with higher score indicating a worse outcome.
Time frame: Up to approximately 4 weeks of double-blind treatment
Number of Participants With One or More Treatment Emergent Adverse Events (AEs) or Any Serious AEs
Evaluate the safety and tolerability of GLWL-01
Time frame: Baseline up to approximately 18 weeks
Caregiver Global Impression of Change (CGIC)
GLWL-01 compared with placebo in the CGIC. Score ranges from 1 to 7, with larger number indicating a worse outcome.
Time frame: Up to approximately 4 weeks of double-blind treatment
Area Under the Concentration Versus Time Curve From Time Zero to 12 Hours (AUC0-12)
Pharmacokinetics (PK) after single and multiple oral dosing
Time frame: Day 14 and Day 42, pre-dose, and 0.5, 1, 2, 4, 6, and between 8 and 12 hours postdose
Maximum Observed Drug Concentration (Cmax)
Pharmacokinetics after single and multiple oral dosing
Time frame: Day 14 and Day 42, pre-dose, and 0.5, 1, 2, 4, 6, and between 8 and 12 hours postdose
Five additional participants screened but not randomized
| Milestone | Treatment Sequence 1 | Treatment Sequence 2 |
|---|---|---|
| Started | 10 | 9 |
| Completed | 10 | 9 |
| Not completed | 0 | 0 |
GLWL-01 compared with placebo on the post-treatment HQ-CT score. Total range of score of zero to 36, with higher score indicating a worse outcome.
| score on a scale | GLWL-01 | Placebo |
|---|---|---|
| Post-treatment Total Score on the Hyperphagia Questionnaire for Clinical Trials (HQ-CT) | 15.9 ± 1.21 | 14.7 ± 1.23 |
Evaluate the safety and tolerability of GLWL-01
| Participants | GLWL-01 | Placebo |
|---|---|---|
| Number of Participants With One or More Treatment Emergent Adverse Events (AEs) or Any Serious AEs | 8 | 7 |
GLWL-01 compared with placebo in the CGIC. Score ranges from 1 to 7, with larger number indicating a worse outcome.
| score on a scale | GLWL-01 | Placebo |
|---|---|---|
| Caregiver Global Impression of Change (CGIC) | 4.0 ± 0.18 | 3.8 ± 0.19 |
Pharmacokinetics (PK) after single and multiple oral dosing
| ng*h/mL | GLWL-01 Single Dose | GLWL-01 Multiple Dose |
|---|---|---|
| Area Under the Concentration Versus Time Curve From Time Zero to 12 Hours (AUC0-12) | 55608 ± 23.6 | 121620 ± 23.7 |
Pharmacokinetics after single and multiple oral dosing
| ng/mL | GLWL-01 Single Dose | GLWL-01 Multiple Dose |
|---|---|---|
| Maximum Observed Drug Concentration (Cmax) | 7885 ± 34.4 | 13695 ± 29.2 |
Collected over Up to 18 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| GLWL | 0/19 (0%) | 0/19 (0%) | 8/19 (42.1%) |
| Placebo | 0/19 (0%) | 0/19 (0%) | 7/19 (36.8%) |
| Event | GLWL | Placebo |
|---|---|---|
| HeadacheNervous system disorders | 3/19 | 4/19 |
| DiarrhoeaGastrointestinal disorders | 3/19 | 0/19 |
| Viral upper respiratory tract infectionInfections and infestations | 2/19 | 1/19 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 0/19 | 2/19 |
| AnxietyNervous system disorders | 0/19 | 2/19 |
| ConstipationGastrointestinal disorders | 1/19 | 0/19 |
| DyspepsiaGastrointestinal disorders | 1/19 | 0/19 |
| Faeces discolouredGastrointestinal disorders | 1/19 | 0/19 |
| Faeces softGastrointestinal disorders | 1/19 | 0/19 |
| Facial painGeneral disorders | 0/19 | 1/19 |
| Age, Continuous(years) | Treatment Sequence 1 | Treatment Sequence 2 | Total |
|---|---|---|---|
| Mean | 22.0 ± 5.54 | 22.1 ± 4.83 | 22.1 ± 5.07 |
| Sex: Female, Male(Participants) | Treatment Sequence 1 | Treatment Sequence 2 | Total |
|---|---|---|---|
| Female | 4 | 5 | 9 |
| Male | 6 | 4 | 10 |
| Ethnicity (NIH/OMB)(Participants) | Treatment Sequence 1 | Treatment Sequence 2 | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 1 | 2 |
| Not Hispanic or Latino | 9 | 8 | 17 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Treatment Sequence 1 | Treatment Sequence 2 | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 10 | 9 | 19 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Treatment Sequence 1 | Treatment Sequence 2 | Total |
|---|---|---|---|
| Canada | 2 | 3 | 5 |
| United States | 8 | 6 | 14 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: GLWL-01
GLWL Research Inc.