Diabetes Mellitus, Type 2Phase 1NCT02377362
A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GLWL-01
A Phase 1 study testing GLWL-01, Part A, GLWL-01, Part B and GLWL-01, Part C in people with Diabetes Mellitus, Type 2, run by GLWL Research Inc. at 4 sites in United States.
Trial summary
This 3-part study will explore the safety and tolerability of GLWL-01 in overweight/obese healthy participants after single doses (in Part A), and in participants with type 2 diabetes mellitus after multiple doses during a 28-day period (Parts B and C). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- GLWL-01, Part A, GLWL-01, Part B and GLWL-01, Part C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 4 sitesUnited States
- Study dates
- Mar 2015to 9 Nov 2016
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- PARTS A-C:
- Non-vasectomized males (or those vasectomized less than 4 months prior to study start) must agree to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days beyond the last dose of study drug
- Males agree to not donate sperm from dosing until 90 days after dosing
- Laboratory test results within normal range or acceptable deviation, and Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) / Gamma Glutamyl Transferase (GGT) / Alkaline Phosphatase (ALP) to be less than or equal to (≤)1.5 x upper limit of normal (ULN), and total bilirubin has to be within normal limit
- Estimated glomerular filtration rate (eGFR) greater than or equal to (≥) 60 milliliter (mL)/minute/1.73m2
- No evidence of weight excursion beyond 5% of baseline weight within 3 months of screening
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- PART A Only:
- Overtly healthy males or females, as determined by medical history and physical examination
- Males must be 18 to 65 years old; females must be 40 to 65 years old
- Female participants must be:
- Women with prior history of hysterectomy who are at least 45 years of age and with follicle-stimulating hormone (FSH) greater than (>) 40 milli-international units per milliliter (mIU/mL), or
- Menopausal women with either: spontaneous amenorrhea for at least 12 months (not induced by a medical condition or medications); or spontaneous amenorrhea for 6 to 12 months and a FSH > 40 mIU/mL
- Body mass index (BMI) of 28 to 35 kilograms divided by height in meters squared (kg/m2)
- Normotensive (supine systolic blood pressure (BP) less than (<) 140 millimeter of mercury (mmHg) and diastolic BP <90 mmHg
- No evidence of weight excursion beyond 5% of baseline weight within 3 months of screening
- PARTS B and C:
- Must have Type 2 Diabetes Mellitus
- Be 18 to 70 years old
- Have BMI of 28 to 42 kg/m2
- Female participants must be of non-childbearing potential, and must have undergone one of the following sterilization procedures at least 6 months prior to first dose: hysteroscopic sterilization, bilateral tubal ligation or bilateral salpingectomy, hysterectomy, or bilateral oophorectomy; or be postmenopausal with amenorrhea for at least 1 year prior to the first dose and with FSH serum levels consistent with postmenopausal status
- Normotensive (supine systolic BP) < 150 mmHg and diastolic BP <95 mmHg or well-controlled hypertension while on a stable hypertensive
Who cannot join
- PARTS A-C:
- Currently enrolled in a clinical trial or any other medical research judged to be not compatible with the study, or have participated in the last 30 days prior to dosing in a clinical trial involving an investigational product or non-approved use of a drug with short half-life, or within 5 half-lives of an investigational product with a half-life longer than 6 days
- Abnormality in the 12-lead electrocardiogram (ECG) including corrected QT (QTc) interval with Bazett's correction >450 milliseconds (msec) for men and >470 msec for women, or an abnormality that, in the opinion of the Investigator, increases the risks associated with participating in the study
- Significant cardiovascular disease or other disorders
- Evidence of human immunodeficiency virus (HIV) infection, hepatitis B, hepatitis C, or other chronic liver or biliary disease
- Average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females), or is unwilling to stop use of Cytochrome P450 (CYP3A) inhibitors/inducers (St. John's Wort) or alcohol consumption for the study, or regular use of known drugs of abuse or positive finding on urinary drug screen, use of cigarettes or nicotine products within last 3 months, or blood donation or loss within 56 days prior to the study
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- Neuropsychiatric disease or pharmacological therapy for such conditions within 1 year of dosing, or antidepressants or antipsychotics within 3 months of dosing, or surgery within last 60 days
- Eating disorder or weight loss medications within 4 months of dosing, or bariatric surgery
- Unsuitable for inclusion in the study in the opinion of the investigator or sponsor
- PART A Only:
- History of hypertension (or on treatment with any antihypertensives)
- Endocrine illness such as diabetes, growth hormone insufficiency / acromegaly, adrenal gland or thyroid illness
- PARTS B and C:
- Currently taking simvastatin > 10 mg per day, or atorvastatin > 20 mg per day, or lovastatin >20 mg per day, or history of statin-induced myopathy / rhabdomyolysis. Participants taking any dose of simvastatin will be excluded from some cohorts
- Allergic to the components of the Mixed Meal Tolerance Test
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Profil Institute for Clinical Research, Inc.
Chula Vista, California, 91911
Clinical Pharmacology of Miami, Inc.
Miami, Florida, 33014
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229
Celerion
Tempe, Arizona, 85283
About this study
Official title: A 3-Part, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose, and Proof of Concept Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GLWL-01
This 3-part study will explore the safety and tolerability of GLWL-01 in overweight/obese healthy participants after single doses (in Part A), and in participants with type 2 diabetes mellitus after multiple doses during a 28-day period (Parts B and C).
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- GLWL-01, Part A, Placebo, Part A, GLWL-01, Part B, Placebo, Part B, GLWL-01, Part C
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLWL-01, Part ADrug
Capsules administered orally, in 2 out of 3 periods
Placebo, Part ADrug
Capsules administered orally in 1 out of 3 periods
GLWL-01, Part BDrug
Capsules administered orally either once or twice daily for 27 days, with a single dose on Day 28
Placebo, Part BDrug
Capsules administered orally either once or twice daily for 27 days with a single dose on Day 28
GLWL-01, Part CDrug
Capsules administered orally either once or twice daily for 27 days with a single dose on Day 28
Placebo, Part CDrug
Capsules administered orally either once or twice daily for 27 days with a single dose on Day 28
| Study group | Role | What they receive |
|---|---|---|
| GLWL-01, Part A | Experimental | Escalating dose in at least 2 of 3 periods, starting at 10 milligrams (mg) Receives: Drug: GLWL-01, Part A |
| Placebo, Part A | Placebo comparator | Escalating dose of placebo to match GLWL-01, in 1 period Receives: Drug: Placebo, Part A |
| GLWL-01, Part B | Experimental | Multiple ascending daily doses of GLWL-01 at up to six dose levels, based on Part A Receives: Drug: GLWL-01, Part B |
| Placebo, Part B | Placebo comparator | Multiple daily doses of placebo to match GLWL-01 Receives: Drug: Placebo, Part B |
| GLWL-01, Part C | Experimental | Multiple daily doses of GLWL-01 at level based upon Part B Receives: Drug: GLWL-01, Part C |
| Placebo, Part C | Placebo comparator | Multiple daily doses of placebo to match GLWL-01 Receives: Drug: Placebo, Part C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With One or More Treatment Emergent Adverse Events (Part A)
Treatment Emergent Adverse Event defined as an adverse event that started or worsened in severity at the time of, or after treatment
Measured: Baseline to 7 weeks
Number of Participants With One or More Treatment Emergent Adverse Events (Parts B)
Treatment Emergent Adverse Event defined as an adverse event that started or worsened in severity at the time of, or after treatment
Measured: Baseline to 6 weeks
Secondary outcomes (30)
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Non-Zero Concentration (AUC0-t) (Part A)
Measured: Pre-dose, 0.5, 1, 2, 4.5, 6, 8.5, 12.5, 24, 28.5, 48, 96 and 144 hours post-dose
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Non-Zero Concentration (AUC0-t) (Part B)
Measured: Predose, 0.5, 1, 2, 4.5, 6, 8.5, 12, 13, 14, 16, 24, 48, 168, and 336 hours post dose starting on Day 28
Area Under the Plasma Concentration-Time Curve From Time Zero to 24-hour Post-Dose (AUC0-24) (Part A)
Measured: Predose, 0.5, 1, 2, 4.5, 6, 8.5, 12, 13, 14, 16, 24 hours post-dose
Area Under the Plasma Concentration-Time Curve From Time Zero to 24-hour Post-Dose (AUC0-24) (Parts B)
Measured: Predose, 0.5, 1, 2, 4.5, 6, 8.5, 12, 13, 14, 16, 24 hours post dose starting on Day 28
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) (Part A)
Measured: Pre-dose, 0.5, 1, 2, 4.5, 6, 8.5, 12.5, 24, 28.5, 48, 96 and 144 hours post-dose
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) (Part B)
Measured: Predose, 0.5, 1, 2, 4.5, 6, 8.5, 12, 13, 14, 16, 24, 48, 168, and 336 hours post dose starting Day 1
Maximum Observed Drug Concentration (Cmax) (Part A)
Measured: Pre-dose, 0.5, 1, 2, 4.5, 6, 8.5, 12.5, 24, 28.5, 48, 96 and 144 hours post-dose
Maximum Observed Drug Concentration (Cmax) (Part B)
Measured: Predose, 0.5, 1, 2, 4.5, 6, 8.5, 12, 13, 14, 16, 24, 48, 168, and 336 hours post dose starting on Day 28
Time to Observed Cmax (Tmax) (Part A)
Measured: Pre-dose, 0.5, 1, 2, 4.5, 6, 8.5, 12.5, 24, 28.5, 48, 96 and 144 hours post-dose
Time to Observed Cmax (Tmax) (Part B)
Measured: Predose, 0.5, 1, 2, 4.5, 6, 8.5, 12, 13, 14, 16, 24, 48, 168, and 336 hours post dose starting on Day 28
Elimination Half-Life (T1/2) (Part A)
Measured: Pre-dose, 0.5, 1, 2, 4.5, 6, 8.5, 12.5, 24, 28.5, 48, 96 and 144 hours post-dose
Elimination Half-Life (T1/2) (Part B)
Measured: Predose, 0.5, 1, 2, 4.5, 6, 8.5, 12, 13, 14, 16, 24, 48, 168, and 336 hours post dose starting on Day 28
Apparent Clearance of Drug (CL/F) (Part A)
Measured: Pre-dose, 0.5, 1, 2, 4.5, 6, 8.5, 12.5, 24, 28.5, 48, 96 and 144 hours post-dose
Apparent Clearance of Drug (CL/F) (Part B)
Measured: Predose, 0.5, 1, 2, 4.5, 6, 8.5, 12, 13, 14, 16, 24, 48, 168, and 336 hours post dose starting on Day 28
Apparent Total Volume of Distribution (VZ/F) (Part A)
Measured: Pre-dose, 0.5, 1, 2, 4.5, 6, 8.5, 12.5, 24, 28.5, 48, 96 and 144 hours post-dose
Apparent Total Volume of Distribution (VZ/F) (Part B)
Measured: Predose, 0.5, 1, 2, 4.5, 6, 8.5, 12, 13, 14, 16, 24, 48, 168, and 336 hours post dose starting on Day 28
Amount of Drug Excreted in Urine (Aet1-t12) (Part A)
Data Not Collected for this Parameter
Measured: Pre-Dose and 12 hours Post-Dose
Amount of Drug Excreted in Urine (Aet1-t12) (Part B)
Data Not Collected for this Parameter
Measured: Pre-Dose and 12 hours Post-Dose on Day 28
Amount of Drug Excreted in Urine (Aet0-24) (Part A)
Measured: Pre-Dose and 24-hours Post-Dose
Amount of Drug Excreted in Urine (Aet0-24) (Part B)
Measured: Pre-Dose and 24-hours Post-Dose on Day 28
Fraction of Drug Excreted in the Urine (Fe) (Part A)
Measured: Pre-Dose and 24-hours Post-Dose
Fraction of Drug Excreted in the Urine (Fe) (Part B)
Measured: Pre-Dose and 24-hours Post-Dose on Day 28
Change From Baseline in Average Plasma Glucose Concentration After Multiple Doses (Part B)
Measured: Baseline to Day 24-26
Change From Baseline in Postprandial Glucose (Part B)
Mixed Meal Tolerance Test (4.5 hours after a meal on Day 28); Baseline Adjusted. The day 28 values were used for analysis; change from baseline was calculated on Day 28.
Measured: Day 28
Change From Baseline in C-Peptide Concentration (Part B)
Mixed Meal Tolerance Test (4.5 hours after a meal on Day 28); Baseline-Adjusted. The day 28 values were used for analysis; change from baseline was calculated on Day 28.
Measured: Day 28
Change From Baseline in Insulin Concentration (Part B)
4.5 hours following Mixed Meal Tolerance Test (MMTT) on Day 28; Baseline Adjusted. The day 28 values were used for analysis; change from baseline was calculated on Day 28.
Measured: Day 28
Fasting Glucose Concentration (Part B)
Fasting glucose concentration after 28 day treatment
Measured: Baseline to Day 28
Change From Baseline in Weight (Part B)
Measured: Baseline to Day 28
Change From Baseline in Waist Circumference (Part B)
Measured: Baseline to Day 28
Change From Baseline in Hip Circumference (Part B)
Measured: Baseline to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startMar 2015
- Primary completion9 Nov 2016
- Study completion9 Nov 2016
Why it stopped: Insufficient efficacy for this indication. The study stopped after Part B.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Mellitus, Type 2Studies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- GLWL Research Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Email choruspharma@lists.lilly.com, Study director, GLWL Research Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02377362
- Sponsor's protocol ID
- GLWL-SMP
- Status last verified
- Mar 2019
- First submitted
- 25 Feb 2015
- Last updated
- 21 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 3-Part, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose, and Proof of Concept Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GLWL-01
- ClinicalTrials.gov ID
- NCT02377362
- Acronym / sponsor ID
- GLWL-SMP
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient efficacy for this indication. The study stopped after Part B.
- Enrolment
- 74 participants (actual)
- Lead sponsor
- GLWL Research Inc.University, hospital or other
- Study start
- Mar 2015
- Primary completion
- 9 Nov 2016 (actual)
- Study completion
- 9 Nov 2016 (actual)
- First posted
- 3 Mar 2015 (estimated)
- Results
- Posted 21 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This 3-part study will explore the safety and tolerability of GLWL-01 in overweight/obese healthy participants after single doses (in Part A), and in participants with type 2 diabetes mellitus after multiple doses during a 28-day period (Parts B and C).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| GLWL-01, Part A | Experimental | Drug: GLWL-01, Part AEscalating dose in at least 2 of 3 periods, starting at 10 milligrams (mg) |
| Placebo, Part A | Placebo comparator | Drug: Placebo, Part AEscalating dose of placebo to match GLWL-01, in 1 period |
| GLWL-01, Part B | Experimental | Drug: GLWL-01, Part BMultiple ascending daily doses of GLWL-01 at up to six dose levels, based on Part A |
| Placebo, Part B | Placebo comparator | Drug: Placebo, Part BMultiple daily doses of placebo to match GLWL-01 |
| GLWL-01, Part C | Experimental | Drug: GLWL-01, Part CMultiple daily doses of GLWL-01 at level based upon Part B |
| Placebo, Part C | Placebo comparator | Drug: Placebo, Part CMultiple daily doses of placebo to match GLWL-01 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Non-vasectomized males (or those vasectomized less than 4 months prior to study start) must agree to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days beyond the last dose of study drug
- Males agree to not donate sperm from dosing until 90 days after dosing
- Laboratory test results within normal range or acceptable deviation, and Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) / Gamma Glutamyl Transferase (GGT) / Alkaline Phosphatase (ALP) to be less than or equal to (≤)1.5 x upper limit of normal (ULN), and total bilirubin has to be within normal limit
- Estimated glomerular filtration rate (eGFR) greater than or equal to (≥) 60 milliliter (mL)/minute/1.73m2
- No evidence of weight excursion beyond 5% of baseline weight within 3 months of screening
Key exclusion criteria (15 listed)
- Currently enrolled in a clinical trial or any other medical research judged to be not compatible with the study, or have participated in the last 30 days prior to dosing in a clinical trial involving an investigational product or non-approved use of a drug with short half-life, or within 5 half-lives of an investigational product with a half-life longer than 6 days
- Abnormality in the 12-lead electrocardiogram (ECG) including corrected QT (QTc) interval with Bazett's correction >450 milliseconds (msec) for men and >470 msec for women, or an abnormality that, in the opinion of the Investigator, increases the risks associated with participating in the study
- Significant cardiovascular disease or other disorders
- Evidence of human immunodeficiency virus (HIV) infection, hepatitis B, hepatitis C, or other chronic liver or biliary disease
- Average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females), or is unwilling to stop use of Cytochrome P450 (CYP3A) inhibitors/inducers (St. John's Wort) or alcohol consumption for the study, or regular use of known drugs of abuse or positive finding on urinary drug screen, use of cigarettes or nicotine products within last 3 months, or blood donation or loss within 56 days prior to the study
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 |
|---|---|---|
| GLWL-01, Part ACapsules administered orally, in 2 out of 3 periods | Drug | GLWL-01, Part A |
| Placebo, Part ACapsules administered orally in 1 out of 3 periods | Drug | Placebo, Part A |
| GLWL-01, Part BCapsules administered orally either once or twice daily for 27 days, with a single dose on Day 28 | Drug | GLWL-01, Part B |
| Placebo, Part BCapsules administered orally either once or twice daily for 27 days with a single dose on Day 28 | Drug | Placebo, Part B |
| GLWL-01, Part CCapsules administered orally either once or twice daily for 27 days with a single dose on Day 28 | Drug | GLWL-01, Part C |
| Placebo, Part CCapsules administered orally either once or twice daily for 27 days with a single dose on Day 28 | Drug | Placebo, Part C |
Primary outcome
Number of Participants With One or More Treatment Emergent Adverse Events (Part A)
Time frame: Baseline to 7 weeks
Treatment Emergent Adverse Event defined as an adverse event that started or worsened in severity at the time of, or after treatment
Number of Participants With One or More Treatment Emergent Adverse Events (Parts B)
Time frame: Baseline to 6 weeks
Treatment Emergent Adverse Event defined as an adverse event that started or worsened in severity at the time of, or after treatment
30 secondary outcomes
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Non-Zero Concentration (AUC0-t) (Part A)
Time frame: Pre-dose, 0.5, 1, 2, 4.5, 6, 8.5, 12.5, 24, 28.5, 48, 96 and 144 hours post-dose
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Non-Zero Concentration (AUC0-t) (Part B)
Time frame: Predose, 0.5, 1, 2, 4.5, 6, 8.5, 12, 13, 14, 16, 24, 48, 168, and 336 hours post dose starting on Day 28
Area Under the Plasma Concentration-Time Curve From Time Zero to 24-hour Post-Dose (AUC0-24) (Part A)
Time frame: Predose, 0.5, 1, 2, 4.5, 6, 8.5, 12, 13, 14, 16, 24 hours post-dose
Area Under the Plasma Concentration-Time Curve From Time Zero to 24-hour Post-Dose (AUC0-24) (Parts B)
Time frame: Predose, 0.5, 1, 2, 4.5, 6, 8.5, 12, 13, 14, 16, 24 hours post dose starting on Day 28
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) (Part A)
Time frame: Pre-dose, 0.5, 1, 2, 4.5, 6, 8.5, 12.5, 24, 28.5, 48, 96 and 144 hours post-dose
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) (Part B)
Time frame: Predose, 0.5, 1, 2, 4.5, 6, 8.5, 12, 13, 14, 16, 24, 48, 168, and 336 hours post dose starting Day 1
Maximum Observed Drug Concentration (Cmax) (Part A)
Time frame: Pre-dose, 0.5, 1, 2, 4.5, 6, 8.5, 12.5, 24, 28.5, 48, 96 and 144 hours post-dose
Maximum Observed Drug Concentration (Cmax) (Part B)
Time frame: Predose, 0.5, 1, 2, 4.5, 6, 8.5, 12, 13, 14, 16, 24, 48, 168, and 336 hours post dose starting on Day 28
Time to Observed Cmax (Tmax) (Part A)
Time frame: Pre-dose, 0.5, 1, 2, 4.5, 6, 8.5, 12.5, 24, 28.5, 48, 96 and 144 hours post-dose
Time to Observed Cmax (Tmax) (Part B)
Time frame: Predose, 0.5, 1, 2, 4.5, 6, 8.5, 12, 13, 14, 16, 24, 48, 168, and 336 hours post dose starting on Day 28
Elimination Half-Life (T1/2) (Part A)
Time frame: Pre-dose, 0.5, 1, 2, 4.5, 6, 8.5, 12.5, 24, 28.5, 48, 96 and 144 hours post-dose
Elimination Half-Life (T1/2) (Part B)
Time frame: Predose, 0.5, 1, 2, 4.5, 6, 8.5, 12, 13, 14, 16, 24, 48, 168, and 336 hours post dose starting on Day 28
Apparent Clearance of Drug (CL/F) (Part A)
Time frame: Pre-dose, 0.5, 1, 2, 4.5, 6, 8.5, 12.5, 24, 28.5, 48, 96 and 144 hours post-dose
Apparent Clearance of Drug (CL/F) (Part B)
Time frame: Predose, 0.5, 1, 2, 4.5, 6, 8.5, 12, 13, 14, 16, 24, 48, 168, and 336 hours post dose starting on Day 28
Apparent Total Volume of Distribution (VZ/F) (Part A)
Time frame: Pre-dose, 0.5, 1, 2, 4.5, 6, 8.5, 12.5, 24, 28.5, 48, 96 and 144 hours post-dose
Apparent Total Volume of Distribution (VZ/F) (Part B)
Time frame: Predose, 0.5, 1, 2, 4.5, 6, 8.5, 12, 13, 14, 16, 24, 48, 168, and 336 hours post dose starting on Day 28
Amount of Drug Excreted in Urine (Aet1-t12) (Part A)
Time frame: Pre-Dose and 12 hours Post-Dose
Amount of Drug Excreted in Urine (Aet1-t12) (Part B)
Time frame: Pre-Dose and 12 hours Post-Dose on Day 28
Amount of Drug Excreted in Urine (Aet0-24) (Part A)
Time frame: Pre-Dose and 24-hours Post-Dose
Amount of Drug Excreted in Urine (Aet0-24) (Part B)
Time frame: Pre-Dose and 24-hours Post-Dose on Day 28
Fraction of Drug Excreted in the Urine (Fe) (Part A)
Time frame: Pre-Dose and 24-hours Post-Dose
Fraction of Drug Excreted in the Urine (Fe) (Part B)
Time frame: Pre-Dose and 24-hours Post-Dose on Day 28
Change From Baseline in Average Plasma Glucose Concentration After Multiple Doses (Part B)
Time frame: Baseline to Day 24-26
Change From Baseline in Postprandial Glucose (Part B)
Time frame: Day 28
Change From Baseline in C-Peptide Concentration (Part B)
Time frame: Day 28
Change From Baseline in Insulin Concentration (Part B)
Time frame: Day 28
Fasting Glucose Concentration (Part B)
Time frame: Baseline to Day 28
Change From Baseline in Weight (Part B)
Time frame: Baseline to Day 28
Change From Baseline in Waist Circumference (Part B)
Time frame: Baseline to Day 28
Change From Baseline in Hip Circumference (Part B)
Time frame: Baseline to Day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Email choruspharma@lists.lilly.com study director
GLWL Research Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GLWL-01, Part A, GLWL-01, Part B and GLWL-01, Part C in people with Diabetes Mellitus, Type 2, run by GLWL Research Inc. at 4 sites in United States.
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 21 inclusion and 15 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: stopped early, as of the sponsor's last update on 21 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With One or More Treatment Emergent Adverse Events (Part A) (time frame: Baseline to 7 weeks). The study lists 2 primary outcomes in all. 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 21 Mar 2019.