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ClinicalTrials.gov ID

NCT07790861

Lead Sponsor

Eli Lilly and CompanyINDUSTRY

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 3

Enrollment

192Estimated

Last Update Posted

Aug 27, 2026Actual

Start Date

Dec 2026Estimated

Primary Completion Date

Mar 2028Estimated

Completion Date

Mar 2028Estimated

Official Title

A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once- Daily Oral Orforglipron Compared With Placebo in Chinese Adult Participants With Obesity or Overweight With Weight-Related Comorbidities

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).

• Obesity
• Overweight

• Orforglipron
• Placebo

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Double

Lead Sponsor

Eli Lilly and CompanyINDUSTRY

13767035719

18805152008