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RecruitingPhase 3

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well orforglipron works and how safe it is for people who are overweight. It looks at whether the drug lowers the future risk of type 2 diabetes, high blood pressure, unhealthy blood fat levels, or class 1 obesity, the lowest level of 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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Your waist size is at least half your height.
  • You have at least one early health problem: blood sugar, blood pressure, or blood fat levels that are above normal but not yet high enough for a diagnosis.
  • You have tried at least once to lose weight through diet and exercise without success.
  • Your BMI (a measure of weight compared with height) is 25 to 29.9, or meets your region's range for overweight.

Who can't join

  • You have any type of diabetes.
  • Your weight has not stayed stable during the 90 days before screening.
  • You have a recorded obesity diagnosis or report ever having a BMI of 30 or higher, or your region's matching cutoff.
  • You have used weight-loss medicines, including nonprescription medicines or alternative treatments, during the 180 days before screening.
  • You have had or plan to have surgery or a procedure to treat obesity.
  • You have high blood pressure or have had it in the past.
  • You have unhealthy blood fat levels, such as cholesterol, or have had them in the past.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (80)

AL

AZ

  • Care Access - 801 South Power Road, Mesa · Mesa, AZ 85206 · Study contact · 877-791-0656Michael Waters · Principal investigatorMore trials in Mesa
  • Absolute Clinical Research · Phoenix, AZ 85051James Beach · Principal investigatorMore trials in Phoenix
  • Synexus Clinical Research US, Inc./Orange Grove Family Practice · Tucson, AZ 85741 · Study contact · 520-333-4515Kevin Pounds · Principal investigatorMore trials in Tucson

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