NCT07790861

Brief Summary

The purpose of this study is to learn how well orforglipron works and how safe it is in Chinese adults with obesity or overweight and related health problems. Participation in this study will last about 53 weeks (about 1 year).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
192

participants targeted

Target at P25-P50 for phase_3 obesity

Timeline
15mo left

Started Dec 2026

Shorter than P25 for phase_3 obesity

Geographic Reach
1 country

13 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 27, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2026

Expected
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

August 27, 2026

Status Verified

August 1, 2026

Enrollment Period

1.2 years

First QC Date

August 25, 2026

Last Update Submit

August 25, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mean Percent Change From Baseline in Body Weight

    Baseline, Week 48

Secondary Outcomes (10)

  • Mean Change from Baseline in Waist Circumference

    Baseline, Week 48

  • Mean Change from Baseline in Body Mass Index (BMI)

    Baseline, Week 48

  • Mean Change from Baseline in Hemoglobin A1c (HbA1c)

    Baseline, Week 48

  • Mean Change from Baseline in Fasting Glucose

    Baseline, Week 48

  • Mean Percent Change from Baseline in Fasting Insulin

    Baseline, Week 48

  • +5 more secondary outcomes

Study Arms (2)

Orforglipron

EXPERIMENTAL

Participants will receive orforglipron orally.

Drug: Orforglipron

Placebo

PLACEBO COMPARATOR

Participants will receive placebo orally.

Drug: Placebo

Interventions

Administered orally.

Also known as: LY3502970
Orforglipron

Administered orally.

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have body mass index (BMI) ≥28.0 kilograms per square meter (kg/m2) and \<30 kg/m2 or ≥24.0 kg/m2 and \<28 kg/m2, and at least 1 of the following weight-related comorbidities at screening:
  • hypertension
  • dyslipidemia
  • obstructive sleep apnea
  • Fatty liver
  • cardiovascular disease
  • Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight

You may not qualify if:

  • Have type 1 diabetes (T1D), type 2 diabetes (T2D), or any other types of diabetes, history of ketoacidosis, or hyperosmolar state/coma
  • Have a self-reported change in body weight \>5 kg within 90 days prior to screening
  • Had chronic or acute pancreatitis any time prior to screening
  • Have family (first-degree relative) or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2) syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Sichuan Provincial People's Hospital

Chengdu, 610072, China

Location

Zhujiang Hospital

Guangzhou, 510280, China

Location

The first Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, 310003, China

Location

Zhejiang Provincial People's Hospital

Hangzhou, 310014, China

Location

The Fourth Affiliated Hospital of Harbin Medical University

Harbin, 150001, China

Location

The Second People's Hospital of Hefei

Hefei, 230011, China

Location

Jinan Central Hospital

Jinan, 250013, China

Location

The First Affiliated Hospital of Henan University of Science &Technology

Luoyang Shi, 471003, China

Location

Jiangxi Provincial People's Hospital

Nanchang, 330006, China

Location

Nanjing First Hospital

Nanjing, 210006, China

Location

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, 210011, China

Location

Jiangsu Province Hospital

Nanjing, 210029, China

Location

Shanghai Sixth People's Hospital

Shanghai, China

Location

MeSH Terms

Conditions

ObesityOverweight

Interventions

orforglipron

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • 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

Central Study Contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

Physicians interested in becoming principal investigators please contact

CONTACT

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2026

First Posted

August 27, 2026

Study Start (Estimated)

December 1, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Last Updated

August 27, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria
A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.
More information

Locations