Type 2 Diabetes MellitusPhase 1L6972-02NCT02250222
Safety and Tolerability Study of Oral LGD-6972 for Type 2 Diabetes Mellitus
A Phase 1 study testing LGD-6972 in people with Type 2 Diabetes Mellitus, run by Ligand Pharmaceuticals at 3 sites in United States.
Trial summary
Ligand Pharmaceuticals Incorporated is developing LGD-6972, a novel, orally-bioavailable addition to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- LGD-6972
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2014to Jun 2015
- Phase
- Phase 1
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Part 1
- Healthy, adult man or woman, 21 to 65 years of age. If the subject is a woman, she must be surgically sterile or naturally post-menopausal to be considered for enrollment.
- Willing and able to provide written informed consent.
- Not diabetic and has a fasting plasma glucose (FPG) between 70 mg/dL and 105 mg/dL, inclusive.
- Good health with no significant concomitant pathology based on medical history, physical examination, electrocardiogram (ECG), routine laboratory tests (chemistry, hematology, lipid profile, international normalized ratio, and urinalysis), and vital signs.
- Part 2
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- Healthy, adult man or woman, 21 to 65 years of age. If the subject is a woman, she must be surgically sterile or naturally post-menopausal to be considered for enrollment.
- Willing and able to provide written informed consent.
- Has T2DM according to American Diabetes Association criteria.
- Currently on stable metformin therapy (unchanged dose for greater than or equal to 12 weeks prior to screening). At the discretion of the investigator, subjects who are drug naïve or whose metformin dose has not been stable for at least 12 weeks at screening, may be started on metformin or have their metformin dose stabilized. Following 12 weeks of stable metformin, they may undergo re screening including assessment of HbA1c and FPG (inclusion criteria 5 and 6).
- Has an HbA1c level between 6.5% and 10.5% at screening. One retest is permitted.
- Venous FPG is 125 mg/dL and 260 mg/dL at screening and either the Day -1 venous FPG or the Day 1 capillary blood glucose (CBG) is 115 mg/dL and 260 mg/dL. One retest is permitted.
- Has a body mass index between 20 and 45 kg/m2, inclusive.
Who cannot join
- Part 1
- Has a recent history of drug and/or alcohol abuse.
- Unwilling to comply with tobacco, nicotine, alcohol, and caffeine restrictions as specified in the protocol.
- Unwilling to comply with restrictions on strenuous exercise as specified in the protocol.
- Has history of clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurologic, psychiatric, immunologic, hematologic, gastrointestinal (including pancreatitis), or metabolic disease requiring medical treatment or has any medical problems that pose an increased risk during the study or that may compromise the integrity of the study data.
- Has liver transaminase levels (aspartate transaminase [AST] or alanine transaminase [ALT]) >10% of the upper limit of normal (ULN), or has creatine kinase (CK) levels >2 × ULN at screening or admission to clinic (Day -1).
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- Has a plasma triglyceride level >400 mg/dL. If triglyceride level is between 400 mg/dL and 500 mg/dL.
- Has a recent history of uncontrolled high blood pressure or has systolic blood pressure <90 mmHg or >140 mmHg or diastolic blood pressure <60 mmHg or >90 mmHg at screening.
- Is taking prescription or non-prescription drugs, vitamins, herbal, and dietary supplements, within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study drug, or is unwilling to refrain from taking any such medication until after the last protocol-specified blood sample. The use of acetaminophen, not to exceed a total daily dose of 1 g, is permitted up to 24 hours prior to admission to the investigational site and then prohibited until after the last protocol-specified blood sample. The use of stable hormone replacement medication by women, topical steroids, and stable thyroid medication is permitted.
- Part 2
- Has a history of hypoglycemic unawareness or recurrent hypoglycemia requiring assistance.
- Has liver transaminase levels (AST or ALT) >10% × ULN, or has CK levels >1.5 × ULN at screening or admission to clinic (Day -1).
- Has history of clinically significant cardiovascular, pulmonary, renal, endocrine (other than T2DM), hepatic, neurologic, psychiatric, immunologic, hematologic, gastrointestinal (including pancreatitis), or metabolic disease requiring medical treatment or has any medical problems that pose an increased risk during the study or that may compromise the integrity of the study data.
- Has a recent history of uncontrolled high blood pressure or has systolic blood pressure <90 mmHg or >140 mmHg or diastolic blood pressure <60 mmHg or >90 mmHg at screening. One retest of blood pressure within 24 hours is permissible at the discretion of the Investigator. Therapy for hypertension (beta blockers excluded) that has been stable for at least one month prior to screening is permitted. At the Investigator's discretion, one anti-hypertensive medication (angiotensin converting enzyme inhibitor, angiotensin receptor blocker, hydrochlorothiazide, or dihydropyridine calcium-channel blocker) may be initiated, or the dosage of a current antihypertensive medication up titrated, in a subject with blood pressure slightly above the eligibility criterion at screening. After at least 4 weeks of stable blood pressure treatment, if the subject's blood pressure has decreased to within the 140/90 mmHg limit, the subject will be fully reassessed for eligibility.
- Has received insulin for more than 6 consecutive days within 6 months prior to screening or has received insulin within 3 months prior to screening.
- Has been treated with peroxisome proliferator-activated receptor gamma agonist, incretin therapy, amylin mimetics, or sodium-glucose linked transporter-2 inhibitor therapy within 12 weeks prior to screening; treatment with other diabetic medications (excluding metformin) within 3 weeks prior to screening.
- Is taking concomitant medications. At least 3 months of stable therapy for thyroid replacement and hypercholesterolemia (gemfibrozil, Welchol, and cholestyramine are not permitted) and at least 4 weeks of stable hypertension medications (as described above) and low dose aspirin are permitted.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Medpace Clinical Pharmacology
Cincinnati, Ohio, 45227
Clinical Pharmacology of Miami, Inc
Miami, Florida, 33014
Celerion, Inc
Tempe, Arizona, 85283
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LGD-6972 in Healthy Subjects and in Subjects With Type 2 Diabetes Mellitus
Ligand Pharmaceuticals Incorporated is developing LGD-6972, a novel, orally-bioavailable addition to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The mechanism of action of LGD-6972 is to reduce the excess liver glucose production characteristic of type 2 diabetes mellitus that is a major contributor to hyperglycemia. This clinical trial will evaluate the safety and tolerability of escalating doses LGD-6972 administered daily over 2 weeks in both healthy subjects and subjects with type 2 diabetes mellitus.
Read the detailed description
This is to be a randomized, double-blind, placebo-controlled, sequential, multiple oral dose study conducted in normoglycemic healthy subjects (NHS) (Part 1) and subjects with type 2 diabetes mellitus (T2DM) who are treated with monotherapy metformin (a stable dose at randomization) along with diet and exercise (Part 2). Subjects with T2DM who are not on a stable dose of metformin but meet all other entry criteria may be enrolled in the study at the discretion of the Investigator, but must undergo a stabilization period of at least 12 weeks before determining eligibility for the study. In Part 1, a single group of healthy subjects will be dosed with repeated oral doses of 15 mg of LGD-6972 or placebo once daily (QD) for 14 days. In Part 2, a maximum of 3 groups of subjects with T2DM will be dosed with 3 sequential, increasing doses of LGD-6972 (5 mg, 10 mg or 15 mg) or placebo QD for 14 days.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- LGD-6972, Placebo (Captisol ®)
- 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.
LGD-6972Drug
Also called LGD-6972 sodium oral solution
LGD-6972 sodium salt powder in Captisol ® (betadex [β-cyclodextrin] sulfobutylether sodium, NF)
Placebo (Captisol ®)Drug
Also called SBECD
betadex [β-cyclodextrin] sulfobutylether sodium, NF
| Study group | Role | What they receive |
|---|---|---|
| Part 1: LGD-6972 15 mg | Experimental | 15 mg LGD-6972 administered once daily (QD) for 14 days. Receives: Drug: LGD-6972 |
| Part 1: Placebo (Captisol ®) | Placebo comparator | Placebo administered once daily (QD) for 14 days. Receives: Drug: Placebo (Captisol ®) |
| Part 2: LGD-6972 5 mg | Experimental | 5 mg LGD-6972 administered orally QD for 14 days. Receives: Drug: LGD-6972 |
| Part 2: LGD-6972 10 mg | Experimental | 10 mg LGD-6972 administered orally QD for 14 days. Receives: Drug: LGD-6972 |
| Part 2: LGD-6972 15 mg | Experimental | 15 mg LGD-6972 administered orally QD for 14 days. Receives: Drug: LGD-6972 |
| Part 2: Placebo (Captisol ®) | Placebo comparator | Placebo administered orally QD for 14 days. Receives: Drug: Placebo (Captisol ®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with one or more drug related adverse events or serious adverse events
Safety and tolerability of repeat (14 days for normoglycemic healthy subjects (NHS) and 14 days for type 2 diabetes mellitus (T2DM) subjects) and sequential increasing oral doses of LGD-6972 in NHS and subjects withT2DM will be compared to NHS and T2DM subjects receiving placebo.
Measured: At least 14 days after last dose
Secondary outcomes (11)
Pharmacokinetic (PK) profile (area under the concentration curve (AUC) of LGD-6972 after repeat oral doses in NHS and in subjects with T2DM
Steady state PK profile (AUC) of LGD-6972 in NHS and in subjects with T2DM will be characterized and compared.
Measured: 14 days
Change from baseline in fasting plasma glucose measured 24 hours after first dose and pre-dose Day 14 of treatment with LGD-6972 in NHS
Measured: 14 days
Change from baseline in fasting plasma glucagon measured 24 hours after first dose and pre-dose Day 14 of treatment with LGD-6972 in NHS
Measured: 14 days
Change from baseline in active and total glucagon-like-peptide (GLP-1) in fasting plasma measured 24 hours after first dose and pre-dose Day 14 of treatment with LGD-6972 in NHS
Measured: 14 days
Change from baseline in fasting plasma glucose measured 24 hours after first dose and at Day 14 of treatment with LGD-6972 in subjects with T2DM
Measured: 14 days
Change from baseline in fasting plasma glucagon measured 24 hours after first dose and at Day 14 of treatment with LGD-6972 in subjects with T2DM
Measured: 14 days
Change from baseline in fasting plasma insulin measured 24 hours after first dose and at Day 14 of treatment with LGD-6972 in subjects with T2DM
Measured: 14 days
Change from baseline in fasting plasma active and total GLP-1 measured 24 hours after first dose and at Day 14 of treatment with LGD-6972 in subjects with T2DM
Measured: 14 days
Change from baseline in 7-point weighted mean glucose during 14 days of treatment with different doses of LGD-6972 in subjects with T2DM
Measured: 14 days
Hemoglobin A1c response during 14 days of treatment with different dosages of LGD-6972 in subjects with T2DM
Measured: 14 days
PK profile (maximum concentration (Cmax) of LGD-6972 after repeat oral doses in NHS and in subjects with T2DM
Steady state PK profile (Cmax) of LGD-6972 in NHS and in subjects with T2DM will be characterized and compared.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2014 (estimated)
- Study startOct 2014
- Primary completionMay 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ligand Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Keith Marschke, Ph.D., Study director, Ligand Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02250222
- Sponsor's protocol ID
- L6972-02
- Acronym
- L6972-02
- Status last verified
- Jun 2015
- First submitted
- 19 Sep 2014
- Last updated
- 11 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LGD-6972 in Healthy Subjects and in Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02250222
- Acronym / sponsor ID
- L6972-02 / L6972-02
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Ligand PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 26 Sep 2014 (estimated)
- 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.
Ligand Pharmaceuticals Incorporated is developing LGD-6972, a novel, orally-bioavailable addition to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The mechanism of action of LGD-6972 is to reduce the excess liver glucose production characteristic of type 2 diabetes mellitus that is a major contributor to hyperglycemia. This clinical trial will evaluate the safety and tolerability of escalating doses LGD-6972 administered daily over 2 weeks in both healthy subjects and subjects with type 2 diabetes mellitus.
Detailed description
This is to be a randomized, double-blind, placebo-controlled, sequential, multiple oral dose study conducted in normoglycemic healthy subjects (NHS) (Part 1) and subjects with type 2 diabetes mellitus (T2DM) who are treated with monotherapy metformin (a stable dose at randomization) along with diet and exercise (Part 2). Subjects with T2DM who are not on a stable dose of metformin but meet all other entry criteria may be enrolled in the study at the discretion of the Investigator, but must undergo a stabilization period of at least 12 weeks before determining eligibility for the study. In Part 1, a single group of healthy subjects will be dosed with repeated oral doses of 15 mg of LGD-6972 or placebo once daily (QD) for 14 days. In Part 2, a maximum of 3 groups of subjects with T2DM will be dosed with 3 sequential, increasing doses of LGD-6972 (5 mg, 10 mg or 15 mg) or placebo QD for 14 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part 1: LGD-6972 15 mg | Experimental | Drug: LGD-697215 mg LGD-6972 administered once daily (QD) for 14 days. |
| Part 1: Placebo (Captisol ®) | Placebo comparator | Drug: Placebo (Captisol ®)Placebo administered once daily (QD) for 14 days. |
| Part 2: LGD-6972 5 mg | Experimental | Drug: LGD-69725 mg LGD-6972 administered orally QD for 14 days. |
| Part 2: LGD-6972 10 mg | Experimental | Drug: LGD-697210 mg LGD-6972 administered orally QD for 14 days. |
| Part 2: LGD-6972 15 mg | Experimental | Drug: LGD-697215 mg LGD-6972 administered orally QD for 14 days. |
| Part 2: Placebo (Captisol ®) | Placebo comparator | Drug: Placebo (Captisol ®)Placebo administered orally QD for 14 days. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Part 1
- Healthy, adult man or woman, 21 to 65 years of age. If the subject is a woman, she must be surgically sterile or naturally post-menopausal to be considered for enrollment.
- Willing and able to provide written informed consent.
- Not diabetic and has a fasting plasma glucose (FPG) between 70 mg/dL and 105 mg/dL, inclusive.
- Good health with no significant concomitant pathology based on medical history, physical examination, electrocardiogram (ECG), routine laboratory tests (chemistry, hematology, lipid profile, international normalized ratio, and urinalysis), and vital signs.
Key exclusion criteria (17 listed)
- Part 1
- Has a recent history of drug and/or alcohol abuse.
- Unwilling to comply with tobacco, nicotine, alcohol, and caffeine restrictions as specified in the protocol.
- Unwilling to comply with restrictions on strenuous exercise as specified in the protocol.
- Has history of clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurologic, psychiatric, immunologic, hematologic, gastrointestinal (including pancreatitis), or metabolic disease requiring medical treatment or has any medical problems that pose an increased risk during the study or that may compromise the integrity of the study data.
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 |
|---|---|---|
| LGD-6972Also: LGD-6972 sodium oral solutionLGD-6972 sodium salt powder in Captisol ® (betadex [β-cyclodextrin] sulfobutylether sodium, NF) | Drug | Part 1: LGD-6972 15 mg, Part 2: LGD-6972 10 mg, Part 2: LGD-6972 15 mg, Part 2: LGD-6972 5 mg |
| Placebo (Captisol ®)Also: SBECDbetadex [β-cyclodextrin] sulfobutylether sodium, NF | Drug | Part 1: Placebo (Captisol ®), Part 2: Placebo (Captisol ®) |
Primary outcome
Number of participants with one or more drug related adverse events or serious adverse events
Time frame: At least 14 days after last dose
Safety and tolerability of repeat (14 days for normoglycemic healthy subjects (NHS) and 14 days for type 2 diabetes mellitus (T2DM) subjects) and sequential increasing oral doses of LGD-6972 in NHS and subjects withT2DM will be compared to NHS and T2DM subjects receiving placebo.
11 secondary outcomes
Pharmacokinetic (PK) profile (area under the concentration curve (AUC) of LGD-6972 after repeat oral doses in NHS and in subjects with T2DM
Time frame: 14 days
Change from baseline in fasting plasma glucose measured 24 hours after first dose and pre-dose Day 14 of treatment with LGD-6972 in NHS
Time frame: 14 days
Change from baseline in fasting plasma glucagon measured 24 hours after first dose and pre-dose Day 14 of treatment with LGD-6972 in NHS
Time frame: 14 days
Change from baseline in active and total glucagon-like-peptide (GLP-1) in fasting plasma measured 24 hours after first dose and pre-dose Day 14 of treatment with LGD-6972 in NHS
Time frame: 14 days
Change from baseline in fasting plasma glucose measured 24 hours after first dose and at Day 14 of treatment with LGD-6972 in subjects with T2DM
Time frame: 14 days
Change from baseline in fasting plasma glucagon measured 24 hours after first dose and at Day 14 of treatment with LGD-6972 in subjects with T2DM
Time frame: 14 days
Change from baseline in fasting plasma insulin measured 24 hours after first dose and at Day 14 of treatment with LGD-6972 in subjects with T2DM
Time frame: 14 days
Change from baseline in fasting plasma active and total GLP-1 measured 24 hours after first dose and at Day 14 of treatment with LGD-6972 in subjects with T2DM
Time frame: 14 days
Change from baseline in 7-point weighted mean glucose during 14 days of treatment with different doses of LGD-6972 in subjects with T2DM
Time frame: 14 days
Hemoglobin A1c response during 14 days of treatment with different dosages of LGD-6972 in subjects with T2DM
Time frame: 14 days
PK profile (maximum concentration (Cmax) of LGD-6972 after repeat oral doses in NHS and in subjects with T2DM
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2015.
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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.
Keith Marschke, Ph.D. study director
Ligand Pharmaceuticals
3 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 LGD-6972 in people with Type 2 Diabetes Mellitus, run by Ligand Pharmaceuticals at 3 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 13 inclusion and 17 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: finished, as of the sponsor's last update on 11 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 drug related adverse events or serious adverse events (time frame: At least 14 days after last dose). 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 11 Jun 2015.