BI 456906 for Diabetes and Obesity

(SYNCHRONIZE™-2 Trial)

Not currently recruiting at 183 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Boehringer Ingelheim

Must be taking: Diet, exercise

Must not be taking: Obesity medications

Disqualifiers: Gastric issues, pancreatitis, thyroid cancer, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 14

Duration: 76 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether survodutide (also known as BI 456906) can help people with both type 2 diabetes and obesity lose weight. Participants are randomly assigned to one of three groups: two groups receive different doses of survodutide, and one group receives a placebo (a non-active substance). The trial is suitable for adults who have not lost weight through diet changes alone and are managing their diabetes with diet, exercise, or specific medications. Participants will receive weekly injections and regular health check-ups over approximately 19 months. The goal is to determine if survodutide effectively aids weight loss compared to a placebo. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but you can only participate if you are treated for diabetes with diet and exercise or specific diabetes medications. If you are on other diabetes medications or obesity treatments, you may need to stop those before joining.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that survodutide, the medicine tested in this study, has generally been well-tolerated in past trials. In earlier studies, individuals who were overweight or had obesity and took survodutide lost a significant amount of weight. For instance, some data indicates a weight loss of nearly 19% in similar groups.

Regarding safety, researchers have closely examined survodutide, especially for its effects on the heart in people with obesity and higher heart risk. This demonstrates a strong focus on ensuring the treatment does not cause serious heart problems.

While no treatment is without risks, the advanced testing of survodutide and its emphasis on weight loss and heart health are promising signs of its safety for humans. Participants in this study will undergo regular health checks to monitor for any unwanted effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about BI 456906 because it targets diabetes and obesity differently than standard treatments like metformin or GLP-1 receptor agonists. This treatment, known as Survodutide, acts as a dual agonist, working on both the GLP-1 and glucagon receptors. This dual action could potentially enhance weight loss and improve blood sugar control more effectively than current options. With two different dosages under investigation, Survodutide offers a promising new approach to managing these conditions with potentially greater efficacy and broader metabolic benefits.

What evidence suggests that survodutide might be an effective treatment for diabetes and obesity?

Research has shown that survodutide (BI 456906), which participants in this trial may receive, can aid weight loss in people with obesity. In one study, participants taking survodutide lost nearly 19% of their body weight. Another study found an average weight loss of 14.9% over about 46 weeks. Survodutide targets two receptors that control hunger and blood sugar levels, promoting weight loss and improving heart and metabolic health. These findings suggest that survodutide could be effective for individuals with obesity and diabetes. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

Adults over 18 with a BMI of 27 or more and type 2 diabetes, treated only with diet/exercise or specific medications, who haven't lost weight through diet changes. Excludes those with certain gastric conditions, recent significant weight change, obesity drug treatment within the last 3 months, or family history of specific thyroid cancer.

Inclusion Criteria

You have been diagnosed with Type 2 Diabetes

Do you struggle with being overweight or obese?

You have tried to lose weight through dieting in the past, but it didn't work.

Exclusion Criteria

I or my family have a history of MTC or MEN 2.

You've lost or gained more than 5% of your body weight in the three months before screening.

I have a severe stomach emptying issue.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive survodutide or placebo injections once a week for about one and a half years, along with diet and exercise counseling

76 weeks

14 visits (in-person), 6 phone calls

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BI 456906
• Placebo

Trial Overview The trial tests survodutide (BI 456906) for weight loss in overweight/obese adults with diabetes. Participants are randomly assigned to receive different doses of survodutide or a placebo weekly for about one and a half years while receiving dietary and exercise counseling.

How Is the Trial Designed?

Group I: Survodutide 6.0 mg Experimental Treatment 1 Intervention

Group II: Survodutide 3.6 mg Experimental Treatment 1 Intervention

Group III: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+

Published Research Related to This Trial

In the SURMOUNT-1 trial, tirzepatide significantly reduced the 10-year predicted risk of developing type 2 diabetes (T2D) compared to placebo, with reductions ranging from 12.4% to 14.7% at week 72, depending on the dosage.

Participants with prediabetes experienced greater risk score reductions (16.0%-20.3%) than those without prediabetes (10.1%-11.3%), indicating that tirzepatide is effective across different glycaemic statuses and body mass index levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tirzepatide reduces the predicted risk of developing type 2 diabetes in people with obesity or overweight: Post hoc analysis of the SURMOUNT-1 trial. Hankosky, ER., Wang, H., Neff, LM., et al.[2023]

Tirzepatide, administered once weekly, was found to be effective in reducing obesity in individuals with type 2 diabetes, as demonstrated in a large phase 3 trial involving multiple centers.

The study was double-blind and placebo-controlled, ensuring robust results that support tirzepatide as a promising treatment option for weight management in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In adults with BMI ≥27 kg/m2 and type 2 diabetes, adding tirzepatide to a lifestyle intervention increased weight loss at 72 wk. Davidson, MB.[2023]

In a Phase II study involving 413 participants with type 2 diabetes, the dual agonist survodutide significantly reduced HbA1c levels and body weight after 16 weeks of treatment, with the most effective doses being 1.8 mg and 2.7 mg once weekly.

Survodutide showed a greater reduction in body weight compared to semaglutide at higher doses, although gastrointestinal side effects were common, affecting 77.8% of participants, suggesting that careful dose escalation may help manage these adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose-response effects on HbA1c and bodyweight reduction of survodutide, a dual glucagon/GLP-1 receptor agonist, compared with placebo and open-label semaglutide in people with type 2 diabetes: a randomised clinical trial. Blüher, M., Rosenstock, J., Hoefler, J., et al.[2023]

Liraglutide and semaglutide, GLP-1 receptor mimetics, have been approved for weight management in obese individuals, showing promising results in Phase III clinical trials.

Tirzepatide, a GLP-1R and GIPR co-agonist, has received Fast Track designation for obesity management and may offer fewer side effects, suggesting it could be a more sustainable option for long-term weight management compared to existing GLP-1R mimetics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

GLP-1/GIP analogs: potential impact in the landscape of obesity pharmacotherapy. Lafferty, RA., Flatt, PR., Irwin, N.[2023]

In two phase I studies involving a total of 149 participants, the dual agonist BI 456906 demonstrated significant weight loss, with a maximum placebo-corrected reduction of 13.8% in body weight observed at week 16 in the multiple rising dose study.

While BI 456906 showed promising efficacy in promoting weight loss, it was associated with an increase in drug-related adverse events, particularly gastrointestinal issues and decreased appetite, leading to discontinuation in some participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I studies of the safety, tolerability, pharmacokinetics and pharmacodynamics of the dual glucagon receptor/glucagon-like peptide-1 receptor agonist BI 456906. Jungnik, A., Arrubla Martinez, J., Plum-Mörschel, L., et al.[2023]

Semaglutide, a GLP-1 receptor agonist, has been shown to produce significant and sustained weight loss in adults with obesity, along with improvements in cardiometabolic risk factors, as demonstrated in the phase 3 STEP trials involving various participants.

The treatment is generally well tolerated, with the most common side effects being mild-to-moderate gastrointestinal issues that are usually temporary and do not require stopping the medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of semaglutide for weight management: evidence from the STEP program. Amaro, A., Sugimoto, D., Wharton, S.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38330987/

Glucagon and GLP-1 receptor dual agonist survodutide for ... This study aimed to investigate the safety, tolerability, and efficacy of glucagon receptor-GLP-1 receptor dual agonist survodutide (BI 456906) in obesity ...

2. boehringer-ingelheim.com boehringer-ingelheim.com/human-health/metabolic-diseases/obesity/phase-ii-clinical-trial-weight-loss-results

Phase II clinical trial weight loss results Data shows nearly 19% weight loss in people with overweight or obesity in Boehringer Ingelheim and Zealand Pharma Phase II trial with survodutide (BI 456906)

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04153929

A Study to Test Whether Different Doses of BI 456906 Are ... The purpose of the study is to find the best dose of BI 456906 that reduces blood sugar. The study also looks at whether BI 456906 helps the participants lose ...

4. jacc.org jacc.org/doi/10.1016/j.jchf.2024.09.004

Survodutide for the Treatment of Obesity: Rationale and ... In a recent phase 2 dose-finding trial, treatment with survodutide resulted in up to a mean 14.9% weight loss over 46 weeks in patients with a ...

5. metabolismjournal.com metabolismjournal.com/article/S0026-0495(24)00074-X/fulltext

A Phase II, randomized, double-blind, placebo-controlled ... Over 46 weeks, survodutide doses ≥2.4 mg substantially improved cardiometabolic outcomes in participants with overweight/obesity.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36527386/

Phase I studies of the safety, tolerability, pharmacokinetics ... BI 456906 produced a placebo-corrected body weight loss of 13.8% (week 16), highlighting its potential to promote clinically meaningful body weight loss.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06077864

NCT06077864 | A Study to Test the Effect of Survodutide ... 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 ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39453356/

Survodutide for the Treatment of Obesity SYNCHRONIZE-CVOT is the first trial that will determine the CV safety and efficacy of survodutide in people with obesity and increased CV risk.

9. boehringer-ingelheim.com boehringer-ingelheim.com/human-health/metabolic-diseases/phase-3-studies-survodutide-obesity-and-overweight

Phase 3 studies survodutide obesity and overweight Data shows nearly 19% weight loss in people with overweight or obesity in Boehringer Ingelheim and Zealand Pharma Phase II trial with ...