Hypertension, Overweight or Obesity
Conditions
Brief summary
GZL1 is an independent study conducted under the GZPL master protocol. GZL1 will evaluate the efficacy and safety of orforglipron for treatment of hypertension in participants with obesity or overweight.
Interventions
DRUGOrforglipron
Administered orally
DRUGPlacebo
placebo administered.
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* refer to the GZPL master protocol for screening eligibility.
Exclusion criteria
* refer to the GZPL master protocol for screening eligibility.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in office Systolic Blood Pressure (SBP) | Baseline to Week 36 |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in 24-hour Ambulatory Blood Pressure Monitoring (ABPM) SBP | Baseline to Week 36 |
| Percent Change from Baseline in Body Weight | Baseline to Week 36 |
| Percent Change from Baseline in Triglycerides | Baseline to Week 36 |
| Percent Change from Baseline in non-HDL Cholesterol | Baseline to Week 36 |
| Percent Change from Baseline in hsCRP Concentration (mg/L) | Baseline to Week 48 |
| Change in office SBP in Randomized Withdrawal Population | Week 48 to Week 60 |
| Pharmacokinetics (PK): Steady-State Area Under the Concentration Curve (AUC) of Orforglipron | Baseline to Week 36 |
Countries
Argentina, China, Czechia, Germany, Greece, India, Japan, Poland, Puerto Rico, Spain, United States
Contacts
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Outcome results
None listed