To Investigate the Safety, Tolerability and Pharmacodynamics of GSK2890457 in Healthy Volunteers and Subjects With Type 2 Diabetes

Completed · Phase 2 · Has a placebo group

Conditions studied: Obesity

In brief

This study is the first administration of GSK2890457 in humans. The study will be conducted in 3 parts: - Part A (conducted at a single investigative site) will determine the safety and tolerability of GSK2890457 alone in healthy subjects during six weeks of dosing, as well as evaluating the potential for a pharmacokinetic interaction with metformin. Part A consists of Screening, Treatment (6 weeks) and Follow-up periods. - Part B (conducted at multiple sites) will determine safety, tolerability, and pharmacodynamics (PD) in subjects with Type 2 diabetes (T2D) when co-dosed for six weeks with liraglutide (Victoza). Part B consists of Screening, Run-in (1 week), Stabilization (12 weeks), Treatment (6 weeks) and Follow-up periods. - Part C (conducted at multiple sites) will determine safety, tolerability, and PD in subjects with T2D when co-dosed for 6 weeks with metformin. Part C consists of Screening, Run-in (1 week), Stabilization (12 weeks), Treatment (6 weeks) and Follow-up periods.

Key facts

Study ID

NCT01725126

Run by

GlaxoSmithKline

People needed

53

Starts

2013-02-10

Expected to finish

2013-09-12

Last updated by the study team

2017-12-13

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• History of gastrointestinal disease, current or chronic history of liver disease, history of serious, severe or unstable physical or psychiatric illness , significant cardiovascular disease, surgery for weight loss or gastrointestinal surgery within 3 months of screening, any documented or reported eating disorder, uncontrolled hypertension, as evidenced by systolic pressure>160 or diastolic pressure >90 mmHg
• Positive test for HIV, Hepatitis B, or Hepatitis C at Screening
• Subjects with significant ECG abnormalities
• For subjects in Part C (continuing metformin), history of untreated pernicious anemia or who have laboratory parameters suggestive of subclinical megaloblastic anemia
• Presence of or symptoms of an active infection
• Uncorrected Thyroid Dysfunction
• History of chronic or acute pancreatitis
• Currently dieting to lose weight including, but not limited to, participation in a program designed to alter body weight within the last 60 days and unwilling to maintain relatively consistent exercise patterns throughout the study
• Current or recent history (within one year of screening) of alcohol or other substance abuse
• Unable to refrain from the use of non-prescription drugs
• Current participation in another clinical study or participation in a clinical study involving an investigational drug within 30 days of the screening visit
• History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy
• An employee of the sponsor or the study site or members of their immediate family.

Where it is running

• GSK Investigational Site — Chula Vista, California, United States
• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — Overland Park, Kansas, United States

Full record on ClinicalTrials.gov

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