A Phase 3, Randomised, Double-blind, Parallel-group, Event-driven, Cardiovascular Safety Study With BI 456906 Administered Subcutaneously Compared With Placebo in Participants With Overweight or Obesity With Established Cardiovascular Disease (CVD) or Chronic Kidney Disease, and/or at Least Two Weight-related Complications or Risk Factors for CVD
Study to Test the Effect of Survodutide on Cardiovascular Safety in People with Overweight or Obesit
Plain English Summary
A Study to Test the Effect of Survodutide (BI 456906) on Cardiovascular Safety in People With Overweight or Obesity (SYNCHRONIZE™ - CVOT) is a Phase 3 clinical trial sponsored by Boehringer Ingelheim studying Obesity. Tests if survodutide (BI 456906) reduces serious heart problems in people with overweight or obesity. For adults aged 18+ with a BMI of 27 kg/m2 or more, or 30 kg/m2 with other health issues. Participation involves weekly injections and regular check-ups for up to 2 years and 3 months. Alternatives include lifestyle changes and other weight loss medications. The trial aims to enroll 5533 participants.
Official Summary
This study is open to adults who are at least 18 years old and have a body mass index (BMI) of 27 kg/m2 or more. People can take part if they have cardiovascular or chronic kidney disease. People who have at least 2 health problems related to their weight or risks of cardiovascular disease can participate. Participants must have previously tried to lose weight by changing their diet. The purpose of this study is to find out whether people with overweight or obesity who take a medicine called survodutide (BI 456906) are less or more likely to develop serious cardiovascular problems. It also aims to find out whether health parameters like blood pressure improve. Overweight and obesity are linked to cardiovascular disease. Survodutide is a medicine that is developed to help people with obesity or overweight to lose weight. Participants are divided into 3 groups of almost equal size. 2 groups get different doses of survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Every participant has a 2 in 3 chance of getting survodutide. Participants inject survodutide or placebo under the skin once a week. All participants also receive counselling on diet and physical activity. Participants are in the study for up to 2 years and 3 months. During this time, it is planned that participants visit the study site up to 21 times and attend remote visits by video calls. During these visits, the doctors check participants' cardiovascular and overall health. The results are compared between survodutide and placebo groups. The study staff also takes note of any unwanted effects.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults aged 18+ with a BMI of 27 kg/m2 or more, or 30 kg/m2 with other health issues can join. Those with type 1 diabetes or recent GLP-1R agonist treatment cannot join. Participants must be at least 18 years old and have a BMI of 27 kg/m2 or more. Health issues include cardiovascular or chronic kidney disease, and at least 2 weight-related complications or risks. This trial is studying Obesity, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measures the time to first occurrence of serious heart problems, which means patients can expect to know if the medication is effective in preventing these issues. The specific primary outcome measures are: Time to first occurrence of any of the adjudicated components of the composite endpoint consisting of: CV death, non-fatal stroke, non-fatal MI, ischaemia related coronary revascularisation, or HFE (to demonstrate non-inferiority) (up to Week 114). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.
Why This Trial Matters
This trial aims to fill the gap in understanding the cardiovascular safety of a new weight loss medication for those with overweight or obesity. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Obesity, where improved treatment options are needed.
Investor Insight
The large market size and competitive landscape suggest a high approval probability for this innovative treatment. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 5533 participants suggests significant investment in this program.
Is This Trial Right for Me?
Ask your doctor if you have any of the required health conditions and if you are willing to commit to regular check-ups and injections. Participants receive weekly injections and regular check-ups, including remote visits. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: QUADRUPLE
- Enrollment: 5,533 participants
Interventions
- COMBINATION_PRODUCT: survodutide — once weekly subcutaneous injection, pre-filled syringe
- COMBINATION_PRODUCT: Placebo — once weekly subcutaneous injection, pre-filled syringe
Primary Outcomes
- Time to first occurrence of any of the adjudicated components of the composite endpoint consisting of: CV death, non-fatal stroke, non-fatal MI, ischaemia related coronary revascularisation, or HFE (to demonstrate non-inferiority) (up to Week 114)
Secondary Outcomes
- Time to first occurrence of any of the adjudicated components of the composite endpoint consisting of: CV death, non-fatal stroke, or non-fatal MI (3-point major adverse cardiac event (3P-MACE)) (to demonstrate non-inferiority) (up to Week 114)
- Absolute change in systolic blood pressure (SBP) (mmHg) from baseline to Week 72 (Baseline and at Week 72)
- Absolute change in waist circumference (cm) from baseline to Week 72 (Baseline and at Week 72)
- Absolute change in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS) from baseline to Week 72 in trial participants with HF at baseline (At Baseline and at Week 72)
- Time to first occurrence of any of the adjudicated components of the composite endpoint consisting of: CV death, non-fatal stroke, non-fatal MI, ischaemia related coronary revascularisation, or HFE (to demonstrate superiority) (up to Week 114)
Full Eligibility Criteria
Inclusion Criteria: 1. Male or female, age ≥18 years at the time of signing informed consent, and at least the legal age of consent in countries where it is \>18 years. 2. Body mass index (BMI) ≥27 kg/m2 at screening with established cardiovascular disease (CVD) and/or at least 2 weight-related complications or risk factors for CVD OR BMI ≥30 kg/m2 at screening with established CVD or chronic kidney disease (CKD), and/or at least 2 weight-related complications or risk factors for CVD. Further inclusion criteria apply. Exclusion criteria: 1. Previous treatment with glucagon-like peptide-1 receptor (GLP-1R) agonists within 3 months before screening. 2. Type 1 diabetes. 3. Less than 3 months between the last dose of GLP-1R agonists and GLP-1R agonist/insulin/glucose-dependent insulinotropic polypeptide (GIP) combinations and screening. 4. Known clinically significant gastric emptying abnormality (e.g., severe diabetic gastroparesis or gastric outlet obstruction). Further exclusion criteria apply.
Trial Locations
- Cardiology P.C., Birmingham, Alabama, United States
- AMR Daphne, Daphne, Alabama, United States
- AMR Mobile, Mobile, Alabama, United States
- Mobile Heart Specialists, PC, Mobile, Alabama, United States
- The Institute for Liver Health II DBA Arizona Clinical Trials, Chandler, Arizona, United States
- Clinical Research Institute of Arizona, LLC, Sun City West, Arizona, United States
- AMR Phoenix, Tempe, Arizona, United States
- Arizona Liver Health-Tucson-67516, Tucson, Arizona, United States
- Yuma Clinical Trials, Yuma, Arizona, United States
- Lynn Institute of the Ozarks, Little Rock, Arkansas, United States
- ...and 10 more locations
Frequently Asked Questions
What is clinical trial NCT06077864?
NCT06077864 is a Phase 3 INTERVENTIONAL study titled "A Study to Test the Effect of Survodutide (BI 456906) on Cardiovascular Safety in People With Overweight or Obesity (SYNCHRONIZE™ - CVOT)." It is currently active, not recruiting and is sponsored by Boehringer Ingelheim. The trial targets enrollment of 5533 participants.
What conditions does NCT06077864 study?
This trial investigates treatments for Obesity. The primary condition under study is Obesity.
What treatments are being tested in NCT06077864?
The interventions being studied include: survodutide (COMBINATION_PRODUCT), Placebo (COMBINATION_PRODUCT). once weekly subcutaneous injection, pre-filled syringe
What does Phase 3 mean for NCT06077864?
Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.
What is the current status of NCT06077864?
This trial is currently "Active, Not Recruiting." It started on 2023-11-20. The estimated completion date is 2026-06-22.
Who is sponsoring NCT06077864?
NCT06077864 is sponsored by Boehringer Ingelheim. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06077864?
The trial aims to enroll 5533 participants. The trial status is active, not recruiting.
How is NCT06077864 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs quadruple masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.
What are the primary outcomes being measured in NCT06077864?
The primary outcome measures are: Time to first occurrence of any of the adjudicated components of the composite endpoint consisting of: CV death, non-fatal stroke, non-fatal MI, ischaemia related coronary revascularisation, or HFE (to demonstrate non-inferiority) (up to Week 114). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06077864 being conducted?
This trial is being conducted at 20 sites, including Birmingham, Alabama; Daphne, Alabama; Mobile, Alabama; Chandler, Arizona and 16 more sites (United States).
Where can I find official information about NCT06077864?
The official record for NCT06077864 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06077864. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06077864 testing in simple terms?
Tests if survodutide (BI 456906) reduces serious heart problems in people with overweight or obesity. For adults aged 18+ with a BMI of 27 kg/m2 or more, or 30 kg/m2 with other health issues.
Why is this trial significant?
This trial aims to fill the gap in understanding the cardiovascular safety of a new weight loss medication for those with overweight or obesity. As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.
What are the potential risks of participating in NCT06077864?
Potential side effects include injection site reactions, headache, and nausea. Monitor for any unusual symptoms and report them to the study team. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06077864?
Ask your doctor if you have any of the required health conditions and if you are willing to commit to regular check-ups and injections. Participants receive weekly injections and regular check-ups, including remote visits. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06077864 signal from an investment perspective?
The large market size and competitive landscape suggest a high approval probability for this innovative treatment. This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.
What happens if the treatment in this trial doesn't work?
Participation involves weekly injections and regular check-ups for up to 2 years and 3 months. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.