RecruitingPHASE1, PHASE2INTERVENTIONAL

A Phase 1/2a Study of WVE-007 in Adults Living With Overweight or Obesity

This study is looking into a new medicine called WVE-007 for adults who are overweight or have obesity. It's an early-stage study, meaning it's one of the first times this medicine is being tested in people. The main goals are to check if the medicine is safe, how well people tolerate it, and how the body uses and reacts to different amounts of it. The study has two parts: one for people who are generally overweight or have obesity, and another for those with obesity who also have pre-diabetes or type 2 diabetes. Participants will receive the medicine as an injection under the skin. This research could help us understand if WVE-007 might be a future treatment option for weight management and related health conditions.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Wave Life Sciences USA, Inc.

Enrolment target

296

Start

31 Jan 2025

Estimated completion

01 Dec 2027

Overweight and Obesity

What is this study about?

This study is exploring a new medicine called WVE-007, which is being investigated as a potential treatment for people who are overweight or have obesity. When doctors talk about being overweight or having obesity, it means carrying extra body fat that can affect your health. This is an early-stage study, so it's a step in understanding if WVE-007 could eventually help.

The study has a few main aims. Firstly, the researchers want to make sure the medicine is safe for people to take and to see if there are any side effects. They also want to understand how the body deals with the medicine – how much is absorbed, how long it stays in the body, and how it might affect your body's processes. This helps them figure out the right dose to use.

The study is divided into two sections. The first part involves adults who are generally overweight or have obesity. The second part focuses on adults living with obesity who also have either 'pre-diabetes' (meaning their blood sugar levels are higher than normal but not yet at the level for type 2 diabetes) or 'type 2 diabetes'. By looking at these different groups, the researchers hope to learn more about how WVE-007 might work to help manage weight and improve related health conditions.

Key takeaways

This is an early-stage study of a new medicine for weight management.
It aims to check the safety and how the body handles WVE-007.
Participants are adults who are overweight or have obesity, including those with pre-diabetes or type 2 diabetes.
The medicine is given as an injection under the skin.
Regular health checks and follow-up visits are part of the study.

Who may be eligible?

To join this study, you'd generally need to be an adult between 18 and 60 years old. If you're in the first part of the study, you would typically have a Body Mass Index (BMI) between 28 and 35. For the second part of the study, which includes people with obesity and pre-diabetes or type 2 diabetes, your BMI would need to be between 35 and 50.

There are also some health conditions that would prevent you from taking part. For example, if you have certain heart problems, severe liver disease, or significant thyroid issues (unless they are well-managed), you likely wouldn't be able to join. The study also has rules about other medications you might be taking or if you've recently participated in another clinical trial.

The research team will carry out a thorough check-up, including looking at your medical history, doing a physical exam, and taking some blood tests, to make sure it's safe for you to participate and that you meet all the specific requirements for the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 60 years old?
Are you considered overweight or do you have obesity?
Do you have a stable weight (not fluctuating a lot) in recent months?
Do you have a healthy heart and normal thyroid function?
Have you avoided other research medicines or certain strong medications recently?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a screening visit. This is where the study team checks if you meet all the requirements. If you do, you would receive the study medicine, WVE-007, which is given as an injection under your skin, similar to a regular shot. Depending on which part of the study you are in, you might receive a single dose or several doses over a period.

Throughout the study, you'll have regular visits to the clinic so the researchers can monitor your health, check for any side effects, and see how the medicine is affecting your body. This will involve physical examinations, blood tests, and other assessments. The study team will explain exactly how many visits you'll need and how long each visit might last.

After you've received the medicine, there will be follow-up visits to continue monitoring your health and any effects of the treatment, even after the last dose. The total length of your participation will depend on which part of the study you're in, but the team will give you a clear schedule before you agree to join.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as closely monitoring your health and possibly receiving a new medicine before it's widely available. However, there are also potential risks, including side effects from the study medicine, which will be carefully explained to you. The research team will do everything they can to minimise these risks. It's very important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (6)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Parexel International-EPCU Baltimore
Verified postcode
Baltimore, United States· Recruiting
ARENSIA Research Clinic
Verified postcode
Chisinau, Moldova· Recruiting
Arensia Clinics S.R.L.
Verified postcode
Bucharest, Romania· Recruiting
Spitalul Clinic Judetean De Urgenta Cluj
Verified postcode
Cluj-Napoca, Romania· Recruiting
Parexel International Early Phase Clinical Unit
Verified postcode
Harrow, United Kingdom· Recruiting
Simbec-Orion Clinical Pharmacology
Verified postcode
Merthyr Tydfil, United Kingdom· Recruiting

Common questions

What is WVE-007?

WVE-007 is a new medicine being tested to see if it can help people who are overweight or have obesity.

Who can join this study?

Adults aged 18-60 who are overweight or have obesity. Specific health checks are needed to confirm qualification.

How is the medicine given?

The medicine, WVE-007, is given as an injection under the skin.

What is the study trying to find out?

The study wants to see if WVE-007 is safe, how the body handles it, and if it could help with weight and related conditions like pre-diabetes.

Can I stop participating at any time?

Yes, you have the right to leave the study at any point, and it won't affect your future medical care.

How to find out more

Clinical Operations

clinicaltrials@wavelifesci.com 855-215-4687 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.