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Type 2 Diabetes MellitusPhase 2NCT02851849

A Study of LGD-6972 in Patients With Type 2 Diabetes Mellitus

A Phase 2 study testing LGD-6972-5 mg, LGD-6972-10 mg and LGD-6972-15 mg in people with Type 2 Diabetes Mellitus, run by Ligand Pharmaceuticals at 29 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the change from baseline in hemoglobin A1c (HbA1c) during 12 weeks of treatment with 3 dose levels of LGD-6972 compared to placebo in subjects with Type 2 Diabetes Mellitus (T2DM) Read more about this study

Who is it for?
Ages 21 to 70 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
LGD-6972-5 mg, LGD-6972-10 mg and LGD-6972-15 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
148 participants
Where
29 sitesUnited States
Study dates
Sep 2016to Jun 2017
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 21 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female subjects must be surgically sterile (hysterectomy or bilateral oophorectomy or bilateral tubal ligation), or naturally post-menopausal for at least 12 months and with a follicle stimulating hormone (FSH) level in the post-menopausal range (if not taking hormone replacement therapy)
  • Male subjects must either have a vasectomy or agree that they and any female partners will use 2 acceptable forms of contraception, one of which must be a condom, until 30 days after the last dose of study drug. Other acceptable forms of contraception include hormonal contraceptives that have been at stable dose for 12 weeks prior to randomization, intrauterine device, Depo-Provera®, Norplant® System Implants, bilateral tubal ligation, bilateral oophorectomy, hysterectomy, and contraceptive sponge, foam, or jelly. Also, male subjects must not donate sperm during the study and for 30 days after the last dose of study drug
  • Willing and able to provide written informed consent
  • Diagnosis of T2DM according to American Diabetes Association criteria
  • Currently on stable metformin or metformin extended-release therapy (unchanged dose [minimum daily dose of 1000 mg] for ≥12 weeks prior to screening)
  • Subjects must have an HbA1c value of ≥7.0% to ≤10.5%
  • Subjects must have a fasting plasma glucose of ≤260 mg/dL
  • Subjects must have a body mass index (BMI) between 25 kg/m2 and 40 kg/m2, inclusive, and must weigh more than 45 kg

Who cannot join

  • History of type 1 diabetes mellitus or history of diabetic ketoacidosis or persistent hypoglycemia or hypoglycemia unawareness
  • Women of childbearing potential, lactating, or has a positive pregnancy test
  • History or presence of alcoholism or drug abuse within 2 years prior to screening
  • Unwilling to comply with study restrictions, including restrictions on strenuous exercise
  • Presence of any of the following conditions: renal impairment (defined as history or estimated glomerular filtration rate at screening of <45 mL/min using the Modification of Diet in Renal Disease equation), diabetic proliferative retinopathy, severely symptomatic diabetic neuropathy requiring treatment, diabetic gastroparesis, active liver disease (other than asymptomatic nonalcoholic fatty liver disease), cirrhosis, symptomatic gall bladder disease, or pancreatitis
  • Serum triglyceride level > 400 mg/dL at screening
Show all 26Show fewer
  • Liver transaminase levels (AST or ALT) >150% ULN, total bilirubin >2 ULN, or creatine kinase (CK) levels > 3 × ULN at screening
  • History or evidence of clinically significant cardiovascular, pulmonary, renal, endocrine (other than T2DM), hepatic, neurologic, psychiatric, immunologic, hematologic, gastrointestinal, or metabolic disease or surgical intervention (eg, bariatric surgery) or allergic conditions (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
  • Myocardial infarction, unstable angina, arterial revascularization, stroke, symptomatic peripheral artery disease, deep vein thrombosis, New York Heart Association Functional Class III or IV heart failure, or transient ischemic attack within 6 months prior to screening
  • History of malignant hypertension or a recent history of uncontrolled high blood pressure or at screening has a seated systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg after at least a 5 minute rest. Blood pressure is determined as the mean of triplicate measurements collected at 2- minute intervals after the subject has been sitting quietly for at least 5 minutes. Therapy for hypertension (beta blockers excluded) that has been stable for at least 8 weeks prior to screening is permitted
  • Arm size in excess of the maximum limit of the largest cuff provided with the study blood pressure monitor
  • History of malignancy (except adequately treated basal or squamous cell skin cancer or cervical carcinoma in situ) within 5 years prior to screening
  • History or evidence of QT prolongation or clinically significant QT prolongation (QTcF >450 msec) at screening, or other significant ECG findings at screening that may place the subject at increased risk by participating in the study
  • Treatment with any type of insulin (injected or inhaled) for > 6 consecutive days within 6 months prior to screening or any insulin therapy within 12 weeks prior to screening
  • Treated with peroxisome proliferator-activated receptor-gamma agonists (thiazolidinediones [TZDs]), incretin therapy (GLP-1 agonists). or amylin mimetics within 12 weeks prior to screening
  • Taking any of the following prohibited medications
  • Antidepressants, antipsychotics, anti-epileptics, hormone replacement therapies (estrogen, progestin), testosterone therapies, and thyroid replacement medications that are not at a stable dose for at least 12 weeks prior to screening
  • Lipid-modifying medications and anti-hypertensive medications that have not been at a stable dose for at least 8 weeks prior to the Screening Visit (excluding bile acid sequestrants, ezetimibe, and beta blockers, which are prohibited
  • Over-the-counter herbal medications and supplement (aside from once daily multivitamins)
  • Treatment with systemic corticosteroids, which must be discontinued at least 4 weeks prior to screening. Note: Inhaled, intraarticular, intranasal and topical corticosteroids are permitted
  • Currently treated with weight-loss medications. These must be discontinued ≥12 weeks prior to screening
  • History or evidence of intravenous illicit drug use, active hepatitis B virus (HBV), hepatitis C virus (HCV), and/or human immunodeficiency virus (HIV) infection
  • Known hypersensitivity or idiosyncratic reaction to glucagon receptor (GCGR) antagonists or LGD-6972
  • Participation in another interventional clinical trial within 30 days prior to dosing or treatment with an investigational product with 14 days or 5 half-lives of the Screening Visit (whichever is longer)
  • Donated ≥ 450 mL of blood within 56 days of screening or has donated blood products within 30 days of screening
  • Inability to comply with study procedures or to adhere to study-required restrictions

Trial locations and contacts

29 sites in 1 country.

29 sites in 1 country

United States29 sites

  • Study site

    Albuquerque, New Mexico, 87102

  • Study site

    Brooksville, Florida, 34601

  • Study site

    Carrollton, Texas, 75007

  • Study site

    Chandler, Arizona, 85224

  • Study site

    Chicago, Illinois, 60607

  • Study site

    Dallas, Texas, 75230

  • Study site

    Denver, Colorado, 80209

  • Study site

    Durham, North Carolina, 27710

  • Study site

    Franklin, Ohio, 45005

  • Study site

    Greensboro, North Carolina, 27410

  • Study site

    Hopewell Junction, New York, 12533

  • Study site

    Houston, Texas, 77036

  • Study site

    Houston, Texas, 77074

  • Study site

    Houston, Texas, 77099

  • Study site

    Huntington Park, California, 90255

  • Study site

    Katy, Texas, 77450

  • Study site

    Las Vegas, Nevada, 89119

  • Study site

    Los Angeles, California, 90057

  • Study site

    Manassas, Virginia, 20110

  • Study site

    Miami, Florida, 33014

  • Study site

    Montclair, California, 91763

  • Study site

    Munroe Falls, Ohio, 44262

  • Study site

    North Hollywood, California, 91606

  • Study site

    Orlando, Florida, 32804

  • Study site

    San Diego, California, 92161

  • Study site

    Summerville, South Carolina, 29485

  • Study site

    Surprise, Arizona, 85374

  • Study site

    Tampa, Florida, 33607

  • Study site

    Tuscumbia, Alabama, 35674

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of Safety and Efficacy of LGD-6972 in Patients With Type 2 Diabetes Mellitus

The purpose of this study is to evaluate the change from baseline in hemoglobin A1c (HbA1c) during 12 weeks of treatment with 3 dose levels of LGD-6972 compared to placebo in subjects with Type 2 Diabetes Mellitus (T2DM)

Read the detailed description

This will be a 12-week, randomized, double-blind, placebo-controlled, 4-arm, parallel group, multi-center study to evaluate the safety and efficacy of LGD-6972 in subjects with T2DM inadequately controlled on metformin monotherapy (a stable [≥12 weeks], daily dose of ≥1000mg at randomization). Subjects with T2DM will be treated with one of 3 dose levels of LGD-6972 (5 mg, 10 mg, or 15 mg) or placebo once daily (QD) for 12 weeks. Randomization will be stratified by HbAlc ≤8.5% or >8.5% at the Placebo Lead-in Visit.

Qualified subjects who require adjustment or stabilization of their metformin dose will participate in a run-in period of up to 12 additional weeks prior to randomization. Subjects will have the option to participate in an oral glucose tolerance test (OGTT) at baseline and end of treatment for assessment of exploratory endpoints.

Being tested
LGD-6972-5 mg, LGD-6972-10 mg, LGD-6972-15 mg, Placebo
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-6972-5 mgDrug

    Also called LGD-6972 sodium salt capsules

    5 mg LGD-6972 QD

  • LGD-6972-10 mgDrug

    Also called LGD-6972 sodium salt capsules

    10 mg LGD-6972 QD

  • LGD-6972-15 mgDrug

    Also called LGD-6972 sodium salt capsules

    15 mg LGD-6972 QD

  • PlaceboOther

    Placebo QD

Study groups in NCT02851849
Study groupRoleWhat they receive
LGD-6972-5 mgActive comparator5 mg LGD-6972 QD
Receives: Drug: LGD-6972-5 mg
LGD-6972-10 mgActive comparator10 mg LGD-6972 QD
Receives: Drug: LGD-6972-10 mg
LGD-6972-15 mgActive comparator15 mg LGD-6972 QD
Receives: Drug: LGD-6972-15 mg
PlaceboPlacebo comparatorPlacebo QD
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in HbA1c

    Measured: 12 Weeks

Secondary outcomes (8)

  1. Change from baseline in HbA1C

    Measured: Baseline to Weeks 2,4,8

  2. Change from baseline in fasting glucose

    Measured: Baseline to Weeks 2,4,8 and 12

  3. Change from baseline values for fasting glucagon

    Measured: Baseline to Weeks 2,4,8 and 12

  4. Change from baseline values for fasting GLP-1 (total and active)

    Measured: Baseline to Weeks 2,4,8 and 12

  5. Change from baseline values for fasting insulin

    Measured: Baseline to Weeks 2,4,8 and 12

  6. Change from baseline values for fasting lipids (total, LDL, and HDL cholesterol and triglycerides)

    Measured: Baseline to Weeks 2,4,8, and 12

  7. Change from baseline in blood pressure (systolic and diastolic)

    Measured: Baseline to Weeks 2,4,8, and 12

  8. Change from baseline in body weight

    Measured: Baseline to Weeks 2,4,8 and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2016 (estimated)
  2. Study startSep 2016
  3. Primary completionJun 2017
  4. Study completionJun 2017

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
148 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02851849
Sponsor's protocol ID
L6972-04
Status last verified
Feb 2017
First submitted
26 Jul 2016
Last updated
12 Jan 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Pettus JH, D'Alessio D, Frias JP, Vajda EG, Pipkin JD, Rosenstock J, Williamson G, Zangmeister MA, Zhi L, Marschke KB. Efficacy and Safety of the Glucagon Receptor Antagonist RVT-1502 in Type 2 Diabetes Uncontrolled on Metformin Monotherapy: A 12-Week Dose-Ranging Study. Diabetes Care. 2020 Jan;43(1):161-168. doi: 10.2337/dc19-1328. Epub 2019 Nov 6.

    PubMed 31694861

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LGD-6972-5 mg, LGD-6972-10 mg and LGD-6972-15 mg in people with Type 2 Diabetes Mellitus, run by Ligand Pharmaceuticals at 29 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 8 inclusion and 26 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 12 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 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 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?

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?

Change from baseline in HbA1c (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02851849, which also lists 1 linked publication.

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 12 Jan 2018.

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