A Master Protocol Study of Orforglipron (LY3502970) in Participants With Hypertension and Obesity or Overweight (ATTAIN-Hypertension) GZL1

Phase 3

Recruiting

• Conditions: Hypertension; Overweight or Obesity
• Interventions: Drug: Orforglipron; Drug: Placebo

• Registration Number: NCT06948435
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-21
• Study First Submitted QC: 2025-04-21
• Study First Posted: 2025-04-29
• Study Start: 2025-04-30
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-26
• Last Update Posted: 2025-06-27
• Primary Completion: 2027-09
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 487

Inclusion Criteria

• refer to the GZPL master protocol for screening eligibility.

Exclusion Criteria

• refer to the GZPL master protocol for screening eligibility.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Orforglipron	Orforglipron	Participants will receive orforglipron orally.
Placebo	Placebo	Administered placebo.

Primary Outcome Measures

Name	Time	Method
Change from Baseline in office Systolic Blood Pressure (SBP)	Baseline to Week 36

Secondary Outcome Measures

Name	Time	Method
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
Change from Baseline in 24-hour Ambulatory Blood Pressure Monitoring (ABPM) SBP	Baseline to Week 36

Trial Locations

Locations (99)

Dallas Heart and Vascular Consultants, PA; 🇺🇸 Duncanville, Texas, United States

Elite Clinical Studies, LLC; 🇺🇸 Phoenix, Arizona, United States

Valley Clinical Trials, Inc.; 🇺🇸 Northridge, California, United States

Chase Medical Research, LLC; 🇺🇸 Waterbury, Connecticut, United States

Excel Medical Clinical Trials; 🇺🇸 Boca Raton, Florida, United States

Care Access - Brandon; 🇺🇸 Brandon, Florida, United States

Northeast Research Institute - Downtown Office; 🇺🇸 Jacksonville, Florida, United States

Peace River Cardiovascular Center; 🇺🇸 Port Charlotte, Florida, United States

Care Access - Sun City Center - Cypress Village Boulevard; 🇺🇸 Sun City Center, Florida, United States

East-West Medical Research Institute; 🇺🇸 Honolulu, Hawaii, United States

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