Not recruiting

Study of orforglipron in people with high blood pressure who are overweight or have obesity

Fast replyInvestigationalNo placebo

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What is this trial about?

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

This clinical trial focuses on evaluating a new medication called Orforglipron (also known as LY3502970) for people who have both hypertension (high blood pressure) and are either overweight or have obesity. The study aims to determine how safe and effective this oral medication is in treating high blood pressure in these individuals.

The research involves testing Orforglipron against a placebo in a carefully controlled study. Participants will take the medication or placebo as capsules once daily. The study will monitor changes in blood pressure, particularly focusing on measuring systolic blood pressure (the top number in a blood pressure reading) over a period of 36 weeks.

The study is designed as two separate but related trials under one master protocol. Both trials will look at how well Orforglipron works in controlling blood pressure in people who are overweight or have obesity. Throughout the study period, which may last up to 60 months, participants will have their blood pressure and other health measurements regularly monitored.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Your blood pressure will be measured to confirm if it meets the required levels: systolic blood pressure of 140 or higher and/or diastolic blood pressure of 90 or higher
Your body mass index (BMI) will be checked to confirm it is 25 or higher
Your current blood pressure medication status will be reviewed - you may either be not taking any medications or using stable blood pressure medications for at least 30 days
Step 2
Treatment period start
You will be randomly assigned to receive either orforglipron capsules or placebo capsules
The capsules need to be taken once daily by mouth
Neither you nor your doctor will know which treatment you are receiving
Step 3
Treatment duration
The treatment period will last for 36 weeks
Your blood pressure will be regularly measured throughout the study to track changes
The main focus will be on changes in your office systolic blood pressure from the start to week 36
Step 4
Study completion
The study is expected to run until May 31, 2027
Your participation will help evaluate how the medication affects blood pressure in people with excess weight or obesity

Who can join the trial?

7 criteria

Age requirement: Must be an adult aged 18-64 years
check
Blood pressure requirements:
- Must have high blood pressure with either:
  - Systolic pressure (top number) of 140 or higher, or
  - Diastolic pressure (bottom number) of 90 or higher (if using only this measure, systolic must be at least 130)
  - Weight requirement: Must have a Body Mass Index (BMI) of 25 or higher, which indicates being overweight or having obesity
  - check
    Current treatment status: Must either:
    
    Not be currently taking any blood pressure medications, or
    Be on the same blood pressure medications for at least 30 days before starting the study
    Gender: Both men and women can participate

Who cannot join the trial?

14 criteria

History of severe high blood pressure (blood pressure readings consistently above 180/110 mmHg)
Pregnancy or breastfeeding women
History of heart attack or stroke within the past 6 months
Current participation in other clinical trials
Severe kidney disease (problems with kidney function)
Severe liver disease (problems with liver function)
Uncontrolled diabetes (consistently high blood sugar levels)
History of substance abuse within the past year
Mental health conditions that could interfere with study participation
Taking medications that could interact with the study drug
History of allergic reactions to similar medications
Unable to follow study procedures or attend scheduled visits
Major surgery planned during the study period
Malignant tumors (cancer) within the past 5 years, except for successfully treated skin cancer

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Verified sites

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

Verified
Ambenet GmbH Das Ambulante Behandlungsnetz
Leipzig, Germany
Verified
Athens Medical Center S.A.
Thessaloniki, Greece
Responsive
Studienzentrum FMZ Radowsky
Leipzig, Germany

Trial locations

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Investigated drugs

Orforglipron is a medication being studied for treating high blood pressure (hypertension) in people who are obese or overweight. It is taken once daily by mouth. This medication belongs to a new class of drugs that may help control blood pressure while also potentially supporting weight management. The drug is still being investigated to understand how well it works and its safety profile.

What is already known about the treatment

Orforglipron - A novel investigational medication administered orally once daily, currently being studied in clinical trials for the treatment of hypertension in patients who are overweight or obese. This drug represents a new therapeutic approach in cardiovascular medicine, being evaluated through a comprehensive master protocol framework. While the exact molecular mechanism is still under investigation in clinical trials, the medication is being studied for its potential effects on blood pressure regulation in combination with weight management. The clinical trials (ATTAIN-HYPERTENSION) are designed to assess both the safety and effectiveness of this treatment option through randomized, double-blind, placebo-controlled studies.

Investigated diseases

Hypertension - A chronic cardiovascular condition characterized by persistently elevated blood pressure in the arteries. Blood pressure is considered high when it consistently measures above 130/80 mmHg. The condition develops gradually over time as the force of blood against artery walls becomes too high. Hypertension can affect various organs in the body, particularly the heart, blood vessels, and kidneys. The condition often develops without noticeable symptoms in its early stages. As blood pressure rises, it can cause changes in blood vessels and organs over time.