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NCT Number: NCT05869903

A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities

This study will investigate the efficacy and safety of once daily oral orforglipron in adult participants with obesity or overweight with weight-related comorbidities. The study has two phases: a main phase and an extension phase. The main phase of the study lasted 72 weeks. Participants with prediabetes will continue in the extension for another 2 years.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Overweight or Obesity Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centro de Pesquisas em Diabetes e Doenças Endócrino-Metabólicas, Fortaleza, Ceará, Brazil

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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 BMI
  • ≥30.0 kilogram/square meter (kg/m²),
  • ≥27.0 kg/m² and presence of at least 1 of the following weight-related comorbidities (treated or untreated) at screening:
  • Hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease (for example, ischemic cardiovascular disease, New York Heart Association Functional Class I-III heart failure).
  • Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.

Exclusion criteria

  • Have Type 1 diabetes, Type 2 diabetes, or any other types of diabetes, history of ketoacidosis, or hyperosmolar state/coma
  • Have a self-reported change in body weight >5 kg (11 pounds) within 90 days prior to screening.
  • Have family (first-degree relative) or personal history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia (MEN)2 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 to Week 72

Secondary outcomes

  1. Mean Change from Baseline in Waist Circumference

    Time frame: Baseline, Week 72

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

    Time frame: Baseline, Week 72

  3. Mean Percent Change from Baseline in Fasting non-HDL Cholesterol

    Time frame: Baseline, Week 72

  4. Mean Percent Change from Baseline in Fasting Triglycerides

    Time frame: Baseline, Week 72

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

    Time frame: Baseline, Week 72

  6. Mean Change from Baseline in Fasting Glucose

    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 Version 2 (SF-36v2) Acute Form Domain Scores

    Time frame: Baseline, Week 72

  10. Mean Percent Change from Baseline in Body Weight in Participants with Prediabetes at Randomization

    Time frame: Baseline, Week 176

  11. Time to Onset of Type 2 Diabetes

    Time frame: Baseline through Week 176, Baseline through Week 190

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 Orforglipron Compared With Placebo in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities (ATTAIN-1)

Acronym: ATTAIN-1

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
May 22, 2023
Registry last updated
Nov 5, 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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