RecruitingPHASE3INTERVENTIONAL

Efficacy and Safety of MET097 Once-Weekly in People With Overweight or Obesity

This research trial is testing a new medication called MET097. It's given as a weekly injection and is for adults who are overweight or have obesity, but do not have type 2 diabetes. The study wants to see how effective MET097 is at helping people lose weight and whether it is safe to use. Researchers are particularly interested in people who have weight-related health problems like high blood pressure or sleep apnoea. The trial will run for 84 weeks (about a year and a half), with the main results assessed after 64 weeks. It’s a ‘Phase 3’ study, which means it’s one of the final steps before a new medicine might become widely available.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Pfizer

Enrolment target

3,501

Start

19 Dec 2025

Estimated completion

25 Apr 2028

Obesity and Overweight

What is this study about?

This study is investigating a new treatment, a weekly injection called MET097, for adults who are overweight or have obesity. The main goal is to find out if this medication can effectively help people lose weight and improve their health, and if it's safe to use.

Being overweight or living with obesity can sometimes lead to other health issues, such as high blood pressure, high cholesterol, sleep apnoea, and heart problems. This trial is specifically designed for people who have these kinds of weight-related health conditions, but it does not include those with type 2 diabetes. By including a diverse group of participants with varying weight-related health concerns, researchers hope to get a clear picture of how MET097 might help people in real-world situations.

The study is called a 'Phase 3' trial. This means it's a large, important step in testing a new medicine. Before a new treatment can be approved for general use, it needs to go through several phases of testing to make sure it works well and is safe. This trial is one of those crucial final steps, helping us understand if MET097 could be a valuable new option for managing weight.

Key takeaways

Tests a new weekly injectable medicine called MET097 for weight management.
Aims to check how well MET097 works for weight loss and if it's safe.
For adults who are overweight or have obesity, but do not have diabetes.
Specifically includes people with other weight-related health problems.
The study lasts for 84 weeks (about 1 year and 9 months).

Who may be eligible?

To join this study, you need to be an adult, aged 18 or over. You should either have obesity (a body mass index, or BMI, of 30 or higher) or be overweight (a BMI between 27 and 30) AND have at least one weight-related health problem. These could include high blood pressure, unhealthy cholesterol levels, sleep apnoea (a condition where breathing stops and starts during sleep), or existing heart problems.

There are also some reasons why you might not be able to take part. For example, you cannot join if you have any type of diabetes. You also can't have had a significant weight change (more than 5 kg or about 11 pounds) in the three months before starting the study. Other conditions that would prevent participation include a personal or family history of a specific type of thyroid cancer called medullary thyroid carcinoma or a related genetic condition (MEN-2). If you have a history of chronic pancreatitis or have had acute pancreatitis recently (in the last six months), or if you currently have active gallbladder disease that causes symptoms, you would also not be eligible.

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 18 years old or older?
Do you have a BMI of 30 or higher, or a BMI of 27-30 with a weight-related health issue (like high blood pressure, high cholesterol, sleep apnoea, or heart problem)?
Do you NOT have any form of diabetes?
Has your weight been stable (not changed by more than 5kg/11lbs) in the last 3 months?
Do you NOT have a personal or family history of certain thyroid cancers or genetic syndromes (MTC or MEN-2)?
Do you NOT have a history of chronic pancreatitis, recent acute pancreatitis, or active gallbladder disease?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive either the new medication, MET097, or a 'placebo' (a dummy treatment that looks like MET097 but contains no active medicine). Neither you nor the study team will know which one you are taking. You will have regular appointments with the study team over a period of 84 weeks (about a year and a half). These visits will involve various health checks, blood tests, and discussions about how you are feeling and any side effects you might be experiencing. The study team will monitor your health carefully throughout the trial. Your main treatment period will last for 64 weeks, with further follow-up until week 84.

Potential risks and benefits

Taking part in this study could potentially offer some benefits, such as receiving a new treatment that might help with weight loss, and having your health closely monitored by medical professionals. However, there are also potential risks; you might experience side effects from the medication, or it might not work for you. As with any medical trial, there's a chance you could receive the placebo and not the active drug. It's really important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (195)

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

Headlands Research
Verified postcode
Scottsdale, United States· Recruiting
Alliance Research Institute
Verified postcode
Canoga Park, United States· Recruiting
Clinical Innovations, Inc dba CITrials
Verified postcode
Riverside, United States· Recruiting
Peninsula Headlands LLC
Verified postcode
Rolling Hills, United States· Recruiting
Collaborative Neuroscience Research, LLC
Verified postcode
Torrance, United States· Recruiting
CenExcel Rocky Mountain Clinical Research, LLC
Verified postcode
Englewood, United States· Recruiting
Research Centers of America
Verified postcode
Hollywood, United States· Recruiting
Future Medical Research (Civia Health)
Verified postcode
Longwood, United States· Recruiting
Advanced Clinical Research
Verified postcode
Miami, United States· Recruiting
Oviedo Medical Research
Verified postcode
Oviedo, United States· Recruiting
CenExel FCR - ForCare Clinical Research
Verified postcode
Tampa, United States· Recruiting
DelRicht Research @ Springer Wellness and Restorative Health
Verified postcode
Atlanta, United States· Recruiting

Common questions

What is a 'Phase 3' study?

It's a big, later-stage study that tests if a new medicine works well and is safe in a larger group of people, before it might be approved for general use.

What is a placebo?

A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active ingredients. It helps researchers compare the new medicine's effects.

How long will the study last?

The study will last for a total of 84 weeks, which is about a year and three-quarters. Your main treatment period will be 64 weeks.

Will I know if I'm getting the real medicine or the placebo?

No, this is a 'blinded' study, meaning neither you nor your study doctor will know if you're receiving MET097 or the placebo until the end of the trial.

Can I still participate if I have type 2 diabetes?

No, this study is specifically for people without any form of diabetes, including type 2 diabetes.

How to find out more

Pfizer CT.gov Call Center

ClinicalTrials.gov_Inquiries@pfizer.com 1-800-718-1021 Official trial record

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