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Study of Orforglipron in Overweight Adults at Risk of Developing Obesity‑Related Complications or Class 1 Obesity

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study looks at people who are classified as Overweight and who have risk factors such as Prehypertension and Prediabetic State. These conditions can lead to Obesity and to health problems like high blood sugar, high blood pressure, and abnormal cholesterol. The medication being tested is an oral tablet called Orforglipron. A matching inactive tablet, called placebo, is also used for comparison.

The purpose is to find out whether taking the study drug can reduce the chance of developing obesity‑related complications or progressing to Class 1 obesity compared with the inactive tablet. Participants will be randomly assigned to receive either the drug or the inactive tablet once each day, and neither the participants nor the study staff will know which one is given (double-blind). Over the course of the trial, participants will attend regular visits where weight, blood pressure and simple blood tests are checked. The study continues until enough time has passed to see whether the drug can delay or prevent the onset of the complications.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization and Receipt of Study Medication

    After joining the study, you will be assigned at random to receive either the active drug orforglipron or a matching placebo. The assignment is double‑blind, meaning neither you nor the study staff will know which one you receive.

    You will be given a supply of tablets that are taken by mouth. The tablets contain orforglipron hemicalcium if you are in the active group, or contain no active ingredient if you are in the placebo group.

  2. Step 2

    Start of Once‑Daily Oral Dosing

    You will take one tablet each day, at approximately the same time each day, by swallowing it with water. This is described as a once‑daily oral tablet regimen.

    The dose listed in the study documents is recorded as “0 Other,” which indicates that the exact amount is defined by the study protocol and is administered as a single tablet each day.

  3. Step 3

    Continued Daily Dosing Throughout the Study

    You will continue to take the assigned tablet every day for the entire duration of the trial, which may extend until the study’s estimated end date of 16 June 2030 unless you discontinue earlier for any reason.

    During this period, you will remain in the study and follow the dosing schedule without interruption.

  4. Step 4

    Regular Assessments for Obesity‑Related Outcomes

    At scheduled visits, you will undergo assessments that check for the development of obesity‑related complications such as type‑2 diabetes, hypertension, or dyslipidemia, as well as for progression to class 1 obesity.

    These assessments are part of the primary endpoint, which measures the time until any of these conditions occur.

  5. Step 5

    Study Completion and Final Evaluation

    When the study reaches its planned conclusion, you will attend a final visit where all remaining measurements are taken and the overall results are recorded.

    After the final evaluation, the study medication will be stopped, and you will receive information about any follow‑up that may be recommended.

Who can join the trial?

6 criteria

  • Have a waist measurement that is at least half of your height (a waist‑to‑height ratio of 0.5 or more). This means your waist is relatively large compared to how tall you are.
  • Have at least one early sign of a health problem related to excess weight, such as prediabetes (higher blood sugar that isn’t yet diabetes), prehypertension (blood pressure that is higher than normal but not yet high blood pressure), or predyslipidemia (blood fats that are a bit elevated but not yet at a disease level).
  • Have tried to lose weight before using diet changes and exercise, but the attempts were not successful.
  • Have a body‑mass index (BMI) between 25 and 29.9 kg/m², which is the range doctors call “overweight.” (BMI is a number calculated from your height and weight.)
  • Be an adult of any gender (both men and women can join the study).
  • Be within the age range defined for the trial (the study includes adults in the standard age groups for clinical research).

Who cannot join the trial?

7 criteria

  • Having any type of diabetes, such as type 1 diabetes (the body makes little or no insulin) or type 2 diabetes (the body does not use insulin well).
  • Not having a stable body weight for at least 90 days before the screening visit (your weight must not have changed a lot during that time).
  • Having an obesity diagnosis or a body‑mass index (BMI) of 30 kg/m² or higher (BMI is a number that compares your weight to your height).
  • Having taken any medicines or over‑the‑counter products meant for weight loss, or using alternative therapies for weight loss, within the past 180 days.
  • Having had, or planning to have, any surgery or medical procedure that is done to treat obesity.
  • Having high blood pressure (hypertension) or a past history of high blood pressure.
  • Having abnormal blood fats (dyslipidemia), which means high cholesterol or triglycerides, or a past history of this condition.
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Investigated drugs

Orforglipron is a pill taken by mouth once each day. In this study, it is being tested to see if it can help people who are overweight avoid developing health problems such as type 2 diabetes, high blood pressure, or abnormal cholesterol, and also to prevent them from moving into the first stage of obesity. The medication is being compared with a placebo to determine how well it works and how safe it is for participants.

What is already known about the treatment

Orforglipron - Orforglipron is taken as a tablet taken by mouth once daily. It is still an experimental drug and is currently being studied in Phase 3 trials, so it is not yet approved for general medical use. The medicine is being tested to help people who are overweight and at risk of developing obesity‑related problems such as diabetes, high blood pressure, or high cholesterol. It works by activating a hormone receptor (the GIP receptor) that helps control appetite and how the body processes sugar and fat, and it belongs to the class of oral GIP‑receptor agonists, a type of metabolic therapy.

Investigated diseases

  • Abdominal obesity

    Excess fat accumulation around the waist, usually measured by waist circumference. It often results from overall weight gain and a sedentary lifestyle. Over time, the stored fat can increase insulin resistance, raise blood pressure, and affect cholesterol levels. This pattern can lead to further health changes if it continues.

  • Overweight

    Body weight that is higher than what is considered normal but does not reach the level of obesity, typically defined by a body‑mass index of 25 to 29.9. It usually develops gradually when calorie intake exceeds energy expenditure. Persistent excess weight can move an individual into the obesity range and may be associated with early metabolic changes.

  • Prehypertension

    Blood pressure that is higher than the normal range but still below the threshold for hypertension, generally systolic 120‑139 mm Hg or diastolic 80‑89 mm Hg. It signals an early rise in arterial pressure. Without lifestyle changes, this level can progress to full‑blown hypertension.

  • Prediabetes

    Blood glucose levels that are above normal but not high enough to meet the criteria for type 2 diabetes, including impaired fasting glucose or impaired glucose tolerance. It reflects early dysfunction in insulin action. If the condition persists, it may advance to type 2 diabetes.

Trial detailsLast updated 21 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2026-526175-35-00Protocol codeJ2A-MC-GZVAEstimated enrolment1 842 patientsSponsorEli Lilly & Co.

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