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Evaluating Orforglipron for Weight Loss in Overweight and Obese Patients with Comorbidities

A Master Protocol to Investigate the Efficacy and Safety of Orforglipron Tablet Once Daily Compared With Placebo in Participants With Obesity or Overweight With and Without Type 2 Diabetes

Phase 3 Interventional Eli Lilly and Company · NCT06972459

This study is testing if a new weight loss medication called orforglipron can help overweight or obese people with other health issues lose weight better than a placebo over 18 months.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment600 (estimated)
Ages18 Years and up
SexAll
SponsorEli Lilly and Company Industry-sponsored
Locations89 sites (Tucson, Arizona and 88 other locations)
Trial IDNCT06972459 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of orforglipron, a medication, in reducing body weight among participants who are overweight or obese and have at least one weight-related health condition, excluding type 2 diabetes. Participants will be compared to a placebo group over a period of approximately 18 months. The study aims to determine if orforglipron can provide significant weight loss benefits in this population. The trial is part of a larger master protocol study.

Who should consider this trial

Good fit: Ideal candidates include individuals with a BMI of 30 or higher, or 25 or higher with at least one weight-related comorbidity such as hypertension or cardiovascular disease.

Not a fit: Patients with diabetes or those who have had unstable body weight or certain cardiovascular conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly aid in weight loss for patients struggling with obesity and related health issues.

How similar studies have performed: Other studies have shown promise with similar weight loss interventions, suggesting potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Have body mass index (BMI) ≥30 kilograms per square meter (kg/m2) or BMI ≥25.0 kg/m2 and at least 1 of the following weight-related comorbidities at screening:

  * hypertension
  * dyslipidemia
  * obstructive sleep apnea, or
  * cardiovascular disease
* Have a history of at least one unsuccessful dietary effort to lose body weight

Exclusion Criteria:

* Have type 1 diabetes, type 2 diabetes, or any other types of diabetes
* Have an unstable body weight within 90 days prior to screening
* Have New York Heart Association functional classification IV congestive heart failure or an acute cardiovascular condition within 90 days prior to screening
* Have acute or chronic hepatitis or pancreatitis
* Are taking other medications or alternative remedies to manage weight loss

Where this trial is running

Tucson, Arizona and 88 other locations

+39 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions ObesityOverweight
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.