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NCT Number: NCT07794579

A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity

This study will evaluate the efficacy and safety of orforglipron in participants with overweight and assess whether it helps reduce the future risk of obesity-related conditions, including type 2 diabetes, hypertension, and dyslipidemia, and progression to class 1 obesity.

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Key information

Conditions

Overweight Body Weight Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Abdominal Overnutrition Pathological Conditions, Signs and Symptoms Prediabetic State Prehypertension Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CARDIAMET Investigaciones Médicas, Buenos Aires, 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 an increased waist-to-height ratio of ≥0.5
  • Have at least one pre-obesity-related complication (prediabetes, prehypertension, predyslipidemia)
  • Have at least one unsuccessful attempt to reduce body weight based on diet and exercise
  • Have a BMI greater than or equal to 25 to less than or equal to 29.9 kg/m2 or equivalent-/region-specific overweight thresholds

Exclusion criteria

  • Have type 1 diabetes, type 2 diabetes, or any other type of diabetes
  • Do not have a stable body weight within 90 days before screening
  • Have a documented obesity diagnosis or self-reported history of BMI ≥30 kg/m² (or an equivalent region-specific threshold)
  • Have taken medications for weight loss, including over-the counter medications or alternative therapies, within 180 days prior to screening
  • Have a prior or planned surgical treatment or procedure for obesity
  • Have hypertension or history of hypertension
  • Have dyslipidemia or history of dyslipidemia

Treatment and study plan

Orforglipron

Drug

Administered orally

Other names: LY3502970

Placebo

Drug

Administered orally

Primary outcomes

  1. Time to Onset of Obesity Related Complications or Class 1 Obesity

    Time frame: Baseline to Week 104

    Obesity related complications defined as type 2 diabetes, hypertension, or dyslipidemia; Class 1 obesity defined as body mass index (BMI) ≥30 kilograms per square meter (kg/m2) or an equivalent region-specific threshold

Secondary outcomes

  1. Percent Change from Baseline in Body Weight

    Time frame: Baseline, Week 104

  2. Time to Onset of Waist-to-Height Ratio ≥0.6

    Time frame: Baseline to Week 104

  3. Change from Baseline in Waist Circumference

    Time frame: Baseline, Week 104

  4. Time to Onset of Class 1 Obesity

    Time frame: Baseline to Week 104

  5. Time to First Occurrence of Composite Endpoint of Type 2 Diabetes, Hypertension, Dyslipidemia

    Time frame: Baseline to Week 104

  6. Time to Onset of Type 2 Diabetes

    Time frame: Baseline to Week 104

  7. Percent Change from Baseline in Total Fat Mass

    Time frame: Baseline, Week 104

  8. Change from Baseline in Systolic Blood Pressure

    Time frame: Baseline, Week 104

  9. Change from Baseline in Glycated Hemoglobin (HbA1c)

    Time frame: Baseline, Week 104

  10. Percent Change from Baseline in Triglycerides

    Time frame: Baseline, Week 104

  11. Change from Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Score

    Time frame: Baseline, Week 104

  12. Pharmacokinetics (PK): Steady-State Area Under the Curve (AUC) of Orforglipron

    Time frame: Week 4, 12, 24, 52, and 76

Study contacts

Contact information is provided by the study sponsor or research team.

Physicians interested in becoming principal investigators please contact

CONTACT

[email protected]

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

[email protected]

317-615-4559

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Once-Daily Oral Orforglipron Compared With Placebo in Individuals With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity

Acronym: ATTAIN-NOW

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Aug 31, 2026
Registry last updated
Aug 31, 2026

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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