A Study of Orforglipron in Adult Participants With Obesity or Overweight and Type 2 Diabetes

NCT05872620
clinicaltrials.gov
Phase
Phase 3
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Recruitment status
Completed
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Participants
1,613
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Lead sponsor
Eli Lilly and Company
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Start date
2023-06-05
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Number of sites
136
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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.
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Acronym
ATTAIN-2
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Short title
A Study of Orforglipron in Adult Participants With Obesity or Overweight and Type 2 Diabetes
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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)
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 3
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Study type
Interventional
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Completion date
2025-08-08
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First posted
2023-05-24
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Registry last updated
2025-09-18
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Primary completion date
2025-08-08
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Start date
2023-06-05
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Actual participants
1,613
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Participants
1,613
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Participant count basis
Actual
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Protocol amendments
1
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Number of sites
136
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Eli Lilly and Company
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05872620
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ClinicalTrials.gov ID
NCT05872620
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

  1. Mean Percent Change from Baseline in Body Weight

    Timeframe: Baseline, Week 72

  1. Mean Change from Baseline in Waist Circumference

    Timeframe: Baseline, Week 72

  2. Mean Change from Baseline in Hemoglobin A1c (HbA1c) %

    Timeframe: Baseline, Week 72

  3. Mean Change from Baseline in Fasting Glucose

    Timeframe: Baseline, Week 72

  4. Mean Change from Baseline in Systolic Blood Pressure (SBP)

    Timeframe: Baseline, Week 72

  5. Mean Change from Baseline in Fasting Triglycerides

    Timeframe: Baseline, Week 72

  6. Mean Percent Change from Baseline in Fasting non-High-Density Lipoprotein (HDL) Cholesterol

    Timeframe: Baseline, Week 72

  7. Mean Percent Change from Baseline in Fasting Insulin

    Timeframe: Baseline, Week 72

  8. Mean Change from Baseline in Diastolic Blood Pressure (DBP)

    Timeframe: Baseline, Week 72

  9. Mean Change from Baseline in Short Form 36 Version 2 Health Survey Acute Form (SF-36v2) Domain Scores

    Timeframe: Baseline, Week 72

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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).

  • 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.
Sources for eligibility
clinicaltrials.gov

  • Cahaba Research - PelhamPelham, United States
  • Novak Clinical Research - Tucson - North La Cholla BoulevardTucson, United States
  • Yuma Clinical TrialsYuma, United States
  • AMCR InstituteEscondido, United States
  • Velocity Clinical Research, Huntington ParkHuntington Park, United States
  • Velocity Clinical Research, WestlakeLos Angeles, United States
  • Catalina Research Institute, LLCMontclair, United States
  • University Clinical Investigators, Inc.Tustin, United States
  • Encore Medical ResearchHollywood, United States
  • East Coast Institute for Research, LLCJacksonville, United States
  • South Florida Clinical Research InstituteMargate, United States
  • Suncoast Clinical Research, Inc.New Port Richey, United States
  • Balanced Life Health Care Solutions/SKYCRNGLawrenceville, United States
  • Endocrine Research Solutions, Inc.Roswell, United States
  • North Georgia Clinical ResearchWoodstock, United States
  • Pacific Diabetes & Endocrine CenterHonolulu, United States
  • Solaris Clinical ResearchMeridian, United States
  • Iowa Diabetes and Endocrinology Research CenterWest Des Moines, United States
  • MedStar Good Samaritan HospitalBaltimore, United States
  • Arcturus Healthcare , PLC, Troy Internal Medicine Research DivisionTroy, United States
  • StudyMetrix ResearchCity of Saint Peters, United States
  • Las Vegas Medical ResearchLas Vegas, United States
  • IMA Clinical ResearchAlbuquerque, United States
  • Albany Medical College, Division of Community EndocrinologyAlbany, United States
  • Albany Stratton VA Medical CenterAlbany, United States

And 111 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • U1111-1289-8799
  • J2A-MC-GZGQ
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (2)