A Master Protocol Study of Orforglipron (LY3502970) in Pa... | NCT06948435

ID	Type	Description	Link
J2A-MC-GZL1	Other Identifier	Eli Lilly and Company
J2A-MC-GZPL	Other Identifier	Eli Lilly and Company

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 30, 2025Actual

Primary Completion Date

Sep 2027Estimated

Completion Date

Sep 2027Estimated

First Submitted Date

Apr 21, 2025

First Submission Date that Met QC Criteria

Apr 21, 2025

First Posted Date

Apr 29, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 28, 2026

Last Update Posted Date

May 29, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

487Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Orforglipron	Experimental	Participants will receive orforglipron orally.	Drug: Orforglipron
Placebo	Placebo Comparator	Administered placebo.	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Orforglipron	Drug	Administered orally	Orforglipron	LY3502970

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from Baseline in office Systolic Blood Pressure (SBP)		Baseline to Week 36

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

refer to the GZPL master protocol for screening eligibility.

Exclusion Criteria:

refer to the GZPL master protocol for screening eligibility.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Call 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	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Elite Clinical Studies, LLC		Phoenix	Arizona	85018	United States
Valley Clinical Trials, Inc.

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Types

Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)

Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.

Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

URL

http://vivli.org/

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D006973	Hypertension
D050177	Overweight
D009765	Obesity

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms