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Completed

NCT Number: NCT05872620

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

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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Key information

Conditions

Obesity Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Type 2 Diabetes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mautalen Salud e Investigación, Buenos Aires, Buenos Aires F.D., Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Orforglipron

Drug

Administered orally

Other names: LY3502970

Placebo

Drug

Administered orally

Primary outcomes

  1. Mean Percent Change from Baseline in Body Weight

    Time frame: Baseline, Week 72

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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)

Acronym: ATTAIN-2

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 24, 2023
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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