A Study of Orforglipron (LY3502970) in Chinese Participants With Obesity or Overweight and Weight-Related Health Problems (ATTAIN-CN)
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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Phase 3
Contacts and Locations
Study Contact
Study Contact
- Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- Phone Number: 1-317-615-4559
- Email: LillyTrials@Lilly.com
Study Contact Backup
- Name: Physicians interested in becoming principal investigators please contact
- Email: clinical_inquiry_hub@lilly.com
Study Locations
-
-
-
Chengdu, China, 610072
- Sichuan Provincial People's Hospital
-
Principal Investigator:
- Limin Tian
-
Guangzhou, China, 510280
- Zhujiang Hospital
-
Principal Investigator:
- Jia Sun
-
Hangzhou, China, 310014
- Zhejiang Provincial People's Hospital
-
Principal Investigator:
- Xiaohong Wu
-
Hangzhou, China, 310003
- The First Affiliated Hospital, Zhejiang University School of Medicine
-
Principal Investigator:
- Xiaomu Li
-
Harbin, China, 150001
- The Fourth Affiliated Hospital of Harbin Medical University
-
Contact:
- Phone Number: 18903602198
-
Principal Investigator:
- ZhiFeng Cheng
-
Hefei, China, 230011
- The Second People's Hospital of Hefei
-
Principal Investigator:
- Yonghong Cao
-
Jinan, China, 250013
- Jinan Central Hospital
-
Principal Investigator:
- Nianrong Mi
-
Luoyang Shi, China, 471003
- The First Affiliated Hospital of Henan University of Science &Technology
-
Principal Investigator:
- Hongwei Jiang
-
Contact:
- Phone Number: 13653880139
-
Nanchang, China, 330006
- Jiangxi Provincial People's Hospital
-
Principal Investigator:
- Zongyou Cheng
-
Contact:
- Phone Number: 13767035719
-
Nanjing, China, 210029
- Jiangsu Province Hospital
-
Principal Investigator:
- Yun Liu
-
Contact:
- Phone Number: 18805152008
-
Nanjing, China, 210006
- Nanjing First Hospital
-
Principal Investigator:
- Qian Li
-
Nanjing, China, 210011
- The Second Affiliated Hospital of Nanjing Medical University
-
Principal Investigator:
- Yibing Lu
-
Contact:
- Phone Number: 18951762960
-
Shanghai, China
- Shanghai Sixth People's Hospital
-
Principal Investigator:
- Jian Zhou
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo
Participants will receive placebo orally.
|
Administered orally.
|
|
Experimental: Orforglipron
Participants will receive orforglipron orally.
|
Administered orally.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Mean Percent Change From Baseline in Body Weight
Time Frame: Baseline, Week 48
|
Baseline, Week 48
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Mean Change from Baseline in Waist Circumference
Time Frame: Baseline, Week 48
|
Baseline, Week 48
|
|
Mean Change from Baseline in Body Mass Index (BMI)
Time Frame: Baseline, Week 48
|
Baseline, Week 48
|
|
Mean Change from Baseline in Hemoglobin A1c (HbA1c)
Time Frame: Baseline, Week 48
|
Baseline, Week 48
|
|
Mean Change from Baseline in Fasting Glucose
Time Frame: Baseline, Week 48
|
Baseline, Week 48
|
|
Mean Percent Change from Baseline in Fasting Insulin
Time Frame: Baseline, Week 48
|
Baseline, Week 48
|
|
Mean Change from Baseline in Systolic Blood Pressure (SBP)
Time Frame: Baseline, Week 48
|
Baseline, Week 48
|
|
Mean Change from Baseline in Diastolic Blood Pressure (DBP)
Time Frame: Baseline, Week 48
|
Baseline, Week 48
|
|
Mean Percent Change from Baseline in Fasting non-HDL Cholesterol
Time Frame: Baseline, Week 48
|
Baseline, Week 48
|
|
Mean Percent Change from Baseline in Fasting Triglycerides
Time Frame: Baseline, Week 48
|
Baseline, Week 48
|
|
Mean Change from Baseline in Short Form Version 2 (SF-36v2) Acute Form Domain Scores
Time Frame: Baseline, Week 48
|
Baseline, Week 48
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Study Director: 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 record dates
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 27942
- J2A-GH-GZVC (Other Identifier: Eli Lilly and Company)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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