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Study of Orforglipron for Weight Management in People with Obesity or Overweight, With or Without Type 2 Diabetes

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What is this trial about?

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

This clinical trial investigates the effectiveness and safety of orforglipron (LY3502970) in people with obesity or overweight with and without Type 2 Diabetes. Obesity is a condition characterized by excessive body fat that may impair health, while overweight refers to having excess body weight for height. The study includes participants who have weight-related health conditions such as hypertension (high blood pressure), dyslipidemia (abnormal blood fat levels), obstructive sleep apnea (breathing interruptions during sleep), or cardiovascular disease (heart and blood vessel conditions).

The purpose of this research is to evaluate how well orforglipron tablets taken once daily work compared to placebo in reducing body weight in people without diabetes and improving blood sugar control in those with diabetes. The study consists of two parts: one for participants with obesity or overweight who have at least one weight-related health condition but do not have diabetes, and another for those who have both weight issues and Type 2 Diabetes.

Participants will first go through a screening period of about 4 weeks before being enrolled in the appropriate study group based on whether they have diabetes. The treatment period will last 40 weeks, during which participants will take either orforglipron or placebo. For diabetes patients, hemoglobin A1c (a measure of average blood sugar levels over 2-3 months) will be monitored to assess improvements in blood sugar control.

The research process

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

Step 1
Screening Phase
You will undergo screening for approximately 4 weeks to determine eligibility for the study.
Based on your health status, you will be enrolled in one of two studies: J2A-MC-GZP1 (if you do not have type 2 diabetes) or J2A-MC-GZP2 (if you have type 2 diabetes).
Step 2
Study Allocation
You will be assigned to either receive the study medication (orforglipron tablet) or a placebo (a tablet that looks identical but contains no active medication).
Neither you nor your study doctor will know which treatment you are receiving.
Step 3
Treatment Period
You will take one tablet of either orforglipron or placebo once daily for 40 weeks.
The exact dosage of orforglipron is not specified in the provided information.
Step 4
Regular Assessments
Throughout the 40-week study period, you will attend regular clinic visits for monitoring.
If you are in the J2A-MC-GZP1 study (without diabetes), your body weight will be measured regularly to track percent change from baseline.
If you are in the J2A-MC-GZP2 study (with diabetes), your hemoglobin A1c (HbA1c) levels will be monitored. HbA1c is a blood test that shows your average blood sugar levels over the past 2-3 months.
Step 5
Final Assessment
At Week 40, final measurements will be taken to evaluate the primary outcomes of the study.
For participants without diabetes, the main measurement will be the percent change in body weight from the beginning of the study.
For participants with diabetes, the main measurement will be the change in HbA1c levels from the beginning of the study.

Who can join the trial?

7 criteria

Have a body mass index (BMI) of 30 or higher, or a BMI of 25 or higher with at least one weight-related health condition such as:
- Hypertension (high blood pressure)
- Dyslipidemia (abnormal levels of fats in the blood, like cholesterol)
- Obstructive sleep apnea (a sleep disorder where breathing repeatedly stops and starts)
- Cardiovascular disease (conditions affecting the heart and blood vessels)
- Have a history of at least one unsuccessful diet attempt to lose weight
- For participants with type 2 diabetes (GZP2 study):
  - Have a BMI of 25 or higher
  - Have hemoglobin A1c (HbA1c) between 7% and 10% (a blood test that measures average blood sugar levels over the past 2-3 months)

Who cannot join the trial?

14 criteria

Body Mass Index (BMI) outside the study requirements. BMI is a measurement that assesses your weight in relation to your height.
Not having obesity or being overweight according to the study criteria.
For GZP1 study: Having type 2 diabetes.
For GZP2 study: Not having type 2 diabetes.
Having certain health conditions that might interfere with the study results or increase risks.
Taking medications that could interact with the study drug orforglipron.
Having participated in another clinical trial within a certain timeframe before this study.
Having allergies or sensitivities to orforglipron or similar medications.
Being pregnant, breastfeeding, or planning to become pregnant during the study period.
Having a history of certain mental health conditions that might affect your ability to follow the study protocol.
Having significant heart, liver, or kidney problems that could make participation unsafe.
Having a history of pancreatitis (inflammation of the pancreas).
Having a personal or family history of medullary thyroid cancer or Multiple Endocrine Neoplasia syndrome type 2 (rare conditions affecting certain glands).
Being unable to follow the study procedures for any reason.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Ambenet GmbH Das Ambulante Behandlungsnetz
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Leipzig, Germany
Donmed s.r.o.
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Ostrava, Czechia
Medical Plus s.r.o.
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Uherske Hradiste, Czechia

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Investigated drugs

Orforglipron Orforglipron is a medication being studied for weight loss in people who have obesity or are overweight. It is taken as a tablet once daily. In people without type 2 diabetes, it is being studied to see how well it helps reduce body weight. In people with type 2 diabetes, it is being studied to see how well it helps control blood sugar levels. The study is looking at both how effective the medication is and how safe it is for patients to use.

What is already known about the treatment

Orforglipron – An oral medication administered as a once-daily tablet being investigated in clinical trials for obesity and type 2 diabetes. Currently in Phase 3 clinical trials (studies GZP1 and GZP2), this experimental drug aims to help reduce body weight in people with obesity or overweight conditions, with or without type 2 diabetes. Orforglipron belongs to the class of GLP-1 receptor agonists, which work by mimicking the hormone GLP-1 to regulate blood sugar levels, increase feelings of fullness, slow stomach emptying, and reduce appetite, potentially leading to weight loss. The medication is being studied both for its weight management benefits and its ability to improve blood sugar control in people with type 2 diabetes.

Investigated diseases

Obesity
A chronic medical condition characterized by excessive accumulation of body fat to an extent that may impair health. It is defined by a body mass index (BMI) of 30 or higher. Obesity develops when energy intake consistently exceeds energy expenditure, leading to storage of excess calories as fat. The condition progresses gradually over time and is influenced by genetic, environmental, behavioral, and hormonal factors. Obesity affects multiple body systems and can lead to metabolic changes.
Overweight
A condition where a person has more body weight than is considered healthy for their height, but not to the degree of obesity. It is typically defined by a body mass index (BMI) between 25 and 29.9. Overweight results from an energy imbalance where caloric intake exceeds energy expenditure over time. The condition may be stable or progress to obesity if the energy imbalance continues. Environmental, genetic, and behavioral factors all contribute to the development of overweight.
Type 2 Diabetes
A metabolic disorder characterized by high blood glucose levels resulting from insulin resistance and relative insulin deficiency. The disease typically develops gradually, with the pancreas initially producing more insulin to overcome the body's increasing resistance. As the condition progresses, the pancreas may become unable to produce sufficient insulin to maintain normal blood glucose levels. Type 2 diabetes often develops silently over years, with many people having the condition for some time before diagnosis. The disease is associated with progressive changes in how the body processes and uses glucose.