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A Study of Orforglipron in Adult Participants With Obesity or Overweight and Type 2 Diabetes (ATTAIN-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05872620
Recruitment Status : Not yet recruiting
First Posted : May 24, 2023
Last Update Posted : May 24, 2023
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:
This study will investigate the safety and efficacy of once daily oral treatment with orforglipron compared with placebo on body weight in adult participants with obesity or overweight and type 2 diabetes. The study will last about 77 weeks and may include up to 22 visits.

Condition or disease Intervention/treatment Phase
Obesity Overweight Type 2 Diabetes Drug: Orforglipron Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once-Daily Oral LY3502970 Compared With Placebo in Adult Participants With Obesity or Overweight and Type 2 Diabetes (ATTAIN-2)
Estimated Study Start Date : June 5, 2023
Estimated Primary Completion Date : June 27, 2025
Estimated Study Completion Date : June 27, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Orforglipron Dose 1
Participants will receive orforglipron administered orally.
 Drug: Orforglipron
Administered orally
Other Name: LY3502970
Experimental: Orforglipron Dose 2
Participants will receive orforglipron administered orally.
 Drug: Orforglipron
Administered orally
Other Name: LY3502970
Experimental: Orforglipron Dose 3
Participants will receive orforglipron administered orally.
 Drug: Orforglipron
Administered orally
Other Name: LY3502970
Placebo Comparator: Placebo
Participants will receive placebo
 Drug: Placebo
Administered orally


Outcome Measures
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Primary Outcome Measures :
  1. Mean Percent Change from Baseline in Body Weight [ Time Frame: Baseline, Week 72 ]

Secondary Outcome Measures :
  1. Mean Change from Baseline in Waist Circumference [ Time Frame: Baseline, Week 72 ]
  2. Mean Change from Baseline in Hemoglobin A1c (HbA1c) % [ Time Frame: Baseline, Week 72 ]
  3. Mean Change from Baseline in Fasting Glucose [ Time Frame: Baseline, Week 72 ]
  4. Mean Change from Baseline in Systolic Blood Pressure (SBP) [ Time Frame: Baseline, Week 72 ]
  5. Mean Change from Baseline in Fasting Triglycerides [ Time Frame: Baseline, Week 72 ]
  6. Mean Percent Change from Baseline in Fasting non-High-Density Lipoprotein (HDL) Cholesterol [ Time Frame: Baseline, Week 72 ]
  7. Mean Percent Change from Baseline in Fasting Insulin [ Time Frame: Baseline, Week 72 ]
  8. Mean Change from Baseline in Diastolic Blood Pressure (DBP) [ Time Frame: Baseline, Week 72 ]
  9. Mean Change from Baseline in Short Form 36 Version 2 Health Survey Acute Form (SF-36v2) Domain Scores [ Time Frame: Baseline, Week 72 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a body mass index (BMI) ≥27.0 kilogram/square meter (kg/m²).
  • Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.

  • Have a diagnosis of Type 2 Diabetes (T2D), with HbA1c ≥7% (≥53 mmol/mol) to ≤10% (86 mmol/mol) and are on stable treatment for T2D for at least 90 days prior to screening, consisting of:

    • either diet/exercise alone or
    • up to 3 oral antihyperglycemic medications (excluding dipeptidyl peptidase IV inhibitors (DPP-4i) or glucagon-like peptide-1 (GLP-1) receptor agonists (RA).

Exclusion Criteria:

  • Have Type 1 Diabetes (T1D), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2D.
  • Have a self-reported change in body weight >5 kg (11 pounds) within 90 days prior to screening.
  • Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema (for example, laster photocoagulation or intravitreal injections of anti-vascular endothelial growth factor inhibitors).
  • Have family (first-degree relative) or personal history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia 2 (MEN2) syndrome.
  • Have had a history of chronic or acute pancreatitis.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05872620


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 ClinicalTrials.gov@lilly.com

Locations
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Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
More Information
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT05872620    
Other Study ID Numbers: 18560
J2A-MC-GZGQ ( Other Identifier: Eli Lilly and Company )
2022-502837-24-00 ( Other Identifier: Eli Lilly and Company )
U1111-1289-8799 ( Other Identifier: UTN Number )
First Posted: May 24, 2023    Key Record Dates
Last Update Posted: May 24, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame:

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/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Obesity
Diabetes Mellitus, Type 2
Overweight
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Body Weight