Not recruiting

Study on the Effects of PF-07976016 and Liraglutide in Adults with Obesity

Verified siteRegistered drugNo 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 is focused on studying the effects of a new treatment for adults with obesity. The study will evaluate a medication known by its code name, PF-07976016-87, which is provided in the form of a film-coated tablet. Participants will also receive a medication called Liraglutide, which is commonly used to help manage weight and is administered as a solution for injection. The trial will also include a comparison with a placebo to assess the effectiveness of the treatment.

The purpose of the study is to compare the effects of different doses of PF-07976016-87 on body weight in individuals with obesity who are already using Liraglutide. Participants will be randomly assigned to receive either the study medication or a placebo, and the study will be conducted in a double-blind manner, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. The study will last for a period of 16 weeks, during which participants' body weight changes will be monitored.

Throughout the study, the safety of the participants will be closely monitored, including any side effects or adverse events that may occur. The study will also assess any changes in mood or behavior using specific questionnaires. The goal is to determine the safety and effectiveness of PF-07976016-87 in helping individuals with obesity manage their weight more effectively.

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
Initial visit
During the initial visit, eligibility is confirmed based on criteria such as age, body mass index (BMI), and willingness to self-administer daily injections of liraglutide (Saxenda®).
Participants must have a stable body weight, defined as less than 5 kg change in the 12 weeks prior to this visit.
Step 2
Randomization
Participants are randomly assigned to receive either the study medicine PF-07976016 or a placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.
Step 3
Treatment phase
Participants receive the assigned treatment for a period of 16 weeks. The study medicine PF-07976016 is administered orally in the form of film-coated tablets.
In addition to the study medicine or placebo, participants continue to receive liraglutide (Saxenda®) via subcutaneous injection as part of their treatment regimen.
Step 4
Monitoring and assessments
Throughout the trial, participants attend scheduled visits for monitoring and assessments. These include laboratory tests, vital signs checks, and electrocardiograms (ECGs).
Participants are also assessed for any adverse events, including changes in mood or behavior, using tools like the Columbia Suicide Severity Rating Scale (C-SSRS) and the Patient Health Questionnaire-8 (PHQ-8).
Step 5
End of treatment evaluation
At the end of the 16-week treatment period, participants undergo a final evaluation to measure the percent change in body weight from the start of the trial.
The incidence of any treatment-emergent adverse events is also reviewed.

Who can join the trial?

6 criteria

Must be a male or a non-pregnant, non-breastfeeding female.
Age must be between 18 to 74 years at the first visit.
Must have a Body Mass Index (BMI) of 30.0 kg/m² or higher at the first visit. BMI is a measure that uses your height and weight to work out if your weight is healthy.
Body weight should be stable, meaning there should be less than a 5 kg change in the 12 weeks before the first visit.
Must be eligible and willing to receive liraglutide (Saxenda®), which is a medication that helps with weight loss, and be able to give yourself daily injections as instructed.
Must be willing and able to attend all scheduled visits, follow the treatment plan, undergo laboratory tests, make lifestyle changes, and follow other study procedures, including keeping a record of medication doses.

Who cannot join the trial?

4 criteria

Participants who are not within the specified age range for the study.
Individuals who are not diagnosed with overweight or obesity.
Participants who are not already using liraglutide, a medication often used to help with weight loss.
Individuals who are part of a vulnerable population, meaning they might need special protection or care.

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Verified sites

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

Verified
Centrum Badan Klinicznych Pi-House Sp. z o.o.
Gdansk, Poland
Verified
Medicome Sp. z o.o.
Oświęcim, Poland
Verified
University Of Debrecen
Debrecen, Hungary

Trial locations

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Investigated drugs

PF-07976016
is an investigational medication being studied to see how it affects body weight in adults with obesity. The trial is designed to test different dose levels of this medication to determine its safety and effectiveness.
Liraglutide
is a medication already used to help manage weight in people with obesity. In this trial, it is used as a background treatment to see how well PF-07976016 works in combination with it.

Liraglutide

What is already known about the treatment

PF-07976016 – This medication is administered orally and is currently being studied in clinical trials for its potential use in treating overweight and obesity. It is in the experimental phase, with ongoing research to determine its safety and effectiveness. The main therapeutic indication is weight reduction in individuals with obesity. At the molecular level, PF-07976016 is believed to work by influencing metabolic pathways that regulate body weight. It is classified pharmacologically as an investigational drug, and its exact mechanism of action is still under investigation.

Investigated diseases

Overweight
This condition is characterized by having more body weight than is considered normal or healthy for a certain height. It is often measured using the Body Mass Index (BMI), where a BMI between 25 and 29.9 is classified as overweight. Overweight can result from a combination of excessive calorie intake, lack of physical activity, and genetic factors. It may lead to increased fat accumulation, particularly around the waist. Over time, being overweight can contribute to the development of other health issues, such as cardiovascular diseases and type 2 diabetes.
Obesity
Obesity is a condition where an individual has an excessive amount of body fat, which can negatively impact health. It is typically defined by a Body Mass Index (BMI) of 30 or higher. Obesity results from a combination of genetic, behavioral, and environmental factors that lead to an energy imbalance. This condition can cause increased strain on the body, affecting joints, breathing, and overall mobility. Over time, obesity can increase the risk of developing chronic diseases such as heart disease, diabetes, and certain cancers.