Weight Loss In Obese Subjects Taking Either GW869682 Or Placebo 3 Times Per Day For 12 Weeks
Trial overview
Percentage change from Baseline (Day -1) in body weight at Week 12
Timeframe: Baseline (Day -1) and Week 12
Absolute change from Baseline (Day -1) in body weight over period
Timeframe: Baseline (Day -1) and up to Week 12
Percentage change from Baseline (Day -1) in body weight over period
Timeframe: Baseline (Day -1) and up to Week 12
Percentage of participants with a loss of at least 3% and 5% of Baseline (Day -1) body weight at Week 12
Timeframe: Baseline (Day -1) and Week 12
Percentage of participants with a loss of at least 10% of Baseline (Day -1) body weight at Week 12
Timeframe: Baseline (Day -1) and Week 12
Change in the percentage of body fat from Baseline (Day -1) at Week 12
Timeframe: Baseline (Day -1) and Week 12
Absolute change from Baseline (Day -1) in body weight up to 16 weeks by body mass index (BMI)
Timeframe: Baseline (Day -1) and up to 16 weeks
Absolute change from Baseline (Day -1) in waist and hip circumference at Weeks 8, 12, 14, and 16
Timeframe: Baseline (Day -1) and Weeks 8, 12, 14, and 16
Mean concentrations of GW869682 and GW869683 analytes over period
Timeframe: Pre-dose, 0.25,0.75, 1.0, 1.75, 4.25, and 6 hours post-dose on Weeks (W) 2 and 11
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Timeframe: Up to 12 weeks for SAEs and up to 16 weeks for AEs
Number of participants with hematological and clinical chemistry parameters outside the clinical concern range
Timeframe: From Screening (21 days prior to Day -1) up to 14 weeks
Change from Baseline (Day -1) in systolic and diastolic blood pressure over period
Timeframe: Baseline (Day -1) and up to Week 16
Change from Baseline (Day -1) in heart rate over period
Timeframe: Baseline (Day -1) and up to 16 weeks
Change from Baseline (Day -1) in 12-lead electrocardiogram parameters over period
Timeframe: Baseline (Day -1) and up to 12 weeks
Mean urine glucose excretion (24-hour intervals) at Weeks 2, 4, 8, 11, and 12
Timeframe: Pre-dose, at Weeks 4, 8, 11, and 12
Change in plasma glucose concentration from Baseline (Day 1) during meal tolerance tests up to Week 2, and Week 11
Timeframe: Baseline (Day -1) or pre-dose, 0.25h, 0.5h, 0.75h, 1.25h, 1.75h, 2.25h, and 4.25h on W2, and W11
Change in plasma insulin concentration from Baseline (Day 1) during meal tolerance tests up to Week 2, and Week 11
Timeframe: Baseline (Day -1), 0.25h, 0.5h, 0.75h, 1.25h, 1.75h, 2.25h, and 4.25h on W2 and W11
Change in plasma C-peptide concentrations from Baseline (Day -1) during meal tolerance tests up to Week 2, and Week 11
Timeframe: Baseline (Day -1), 0h, 0.25h, 0.5h, 0.75h, 1.25h, 1.75h, 2.25h, and 4.25h on W2, and W11
Number of participants with positive dipstick results for blood occult and adverse event of hematuria
Timeframe: Up to 14 weeks
Change from Baseline (Day -1) in plasma Glucagon-like peptide-1 (GLP-1) concentration at Weeks 2 and 11
Timeframe: Baseline (Day -1), Weeks 2, and 11
Steady state pharmacokinetic parameters for GW869682 and GW869683 analytes over period
Timeframe: Up to Week 12
Participation criteria
- Inclusion criteria:
- Have a BMI within range 30.0 to 40.0kg/m2, inclusive.
- Inclusion criteria:
- Have a BMI within range 30.0 to 40.0kg/m2, inclusive.
- Females who meet above criteria must be physiologically incapable of becoming pregnant (ie., surgically sterilized, or post-menopausal per protocol definition). Exclusion criteria:
- History of eating disorders.
- Recent history of weight loss or gain.
- Had gastrointestinal surgery for treatment of obesity.
- Type 1 or type 2 diabetes mellitus.
- Have a positive urine drug screen.
- Have liver disease.
- Have hepatitis B, hepatitis C, or HIV antibodies.
- Have a thyroid disorder that is not under control with medication.
- Have any disease (such as heart, liver, blood, nervous system, or kidney disease, or cancer).
- Are unable to participate in an exercise program.
- Have used weight loss drugs within 3 months before the start of the study.
- Are currently using warfarin, digoxin, oral anti-coagulants (other than aspirin and non-steroidal anti-inflammatory drugs), oral or injectable corticosteroids (inhaled & intranasal corticosteroids are permitted), or antiretroviral medications.
- Used of any investigational drug or device during the study or within 30 days prior to 1st dosing of study medication.
- High or low blood pressure.
Trial location(s)
Study documents
No study documents available.
Results overview
Results posted on ClinicalTrials.gov
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.