Survodutide for Obesity

Recruiting at 2 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Boehringer Ingelheim

Must not be taking: Obesity medications

Disqualifiers: Significant alcohol, Liver disease, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8-10 months

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new medicine, survodutide, helps people with obesity by improving energy use and fat breakdown. It compares survodutide to semaglutide, a treatment already used for obesity. Participants receive either survodutide or semaglutide as a weekly injection, assigned randomly. The trial seeks individuals with a body mass index (BMI) between 30 and 45 who are willing to follow study procedures, including injections and lifestyle advice. As a Phase 1 trial, this research focuses on understanding how the new treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Will I have to stop taking my current medications?

The trial requires that you stop taking any medications for obesity at least 3 months before joining. Other medications are not specifically mentioned, so it's best to discuss your current medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that survodutide, a new treatment for obesity, may cause stomach-related side effects. However, no deaths have been reported, suggesting it is relatively safe. Semaglutide, the other treatment in the study, has already received approval for obesity, indicating its safety for this condition. Both treatments are administered as weekly injections under the skin. Participants in the study will be closely monitored for any side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Survodutide is unique because it introduces a fresh approach to tackling obesity by combining dual mechanisms of action. Unlike standard treatments such as orlistat or phentermine, which focus primarily on appetite suppression or fat absorption, survodutide targets both the glucagon and GLP-1 receptors. This dual action not only helps reduce appetite but may also increase energy expenditure, offering a potentially more comprehensive solution for weight loss. Researchers are excited because this could lead to more significant and sustained weight loss compared to existing options.

What evidence suggests that this trial's treatments could be effective for obesity?

Research has shown that survodutide, one of the treatments studied in this trial, yields promising results for treating obesity. In earlier studies, patients lost up to 19% of their body weight. Survodutide also lowered hemoglobin A1c, a measure of blood sugar levels, suggesting potential benefits for those with obesity-related health issues. Meanwhile, semaglutide, another treatment option in this trial, is already an approved and effective treatment for obesity. Both treatments aim to promote weight loss and improve overall health. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

Adults aged 18-65 with obesity (BMI of 30-45 kg/m²) can join this study. Women must use effective birth control, and participants should be able to self-inject the medication or have someone who can do it for them. They need to follow lifestyle advice and trial procedures throughout the study.

Inclusion Criteria

Woman of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2)

I am willing and able to inject the medication myself or have someone do it for me.

My BMI is between 30 and 45.

Exclusion Criteria

I have a history of chronic liver disease or cirrhosis.

Glycated haemoglobin (HbA1c) ≥6.5% as measured by the local laboratory at screening

Body weight variation >5% within 3 months before Visit 1 (screening)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either survodutide or semaglutide as an injection under the skin once a week

8-10 months

Weekly visits (in-person or at home)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Semaglutide
• Survodutide

Trial Overview The trial is testing Survodutide against Semaglutide in people with obesity to see if it improves energy usage and fat breakdown. Participants are randomly assigned to receive one of these drugs via weekly injections for about 8 months, with regular health checks and tests measuring oxygen intake and carbon dioxide output.

How Is the Trial Designed?

Group I: Survodutide arm Experimental Treatment 1 Intervention

Group II: Semaglutide arm Active Control 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

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]

Subcutaneous semaglutide (Wegovy) has been shown to significantly reduce body weight in overweight and obese individuals, with a dose-dependent effect observed in four Phase 3 trials involving 5000 participants.

While semaglutide resulted in greater weight loss compared to placebo, gastrointestinal side effects were the most common safety concerns, highlighting the need for further studies in diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical review of subcutaneous semaglutide for obesity. Phillips, A., Clements, JN.[2022]

Semaglutide, a glucagon-like peptide-1 receptor agonist, has been shown to produce the largest weight loss of any obesity medication, with an average reduction of about 15% of initial body weight over 68 weeks.

In addition to significant weight loss, semaglutide also improves cardiovascular risk factors and physical functioning, making it a promising option for chronic weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semaglutide for the treatment of obesity. Chao, AM., Tronieri, JS., Amaro, A., et al.[2023]

In a phase 3 trial involving 667 adults with overweight or obesity, oral semaglutide 50 mg taken daily resulted in a significant average weight loss of 15.1% compared to only 2.4% with placebo over 68 weeks, demonstrating its efficacy in weight management.

While semaglutide was effective, it was associated with a higher incidence of adverse events, particularly gastrointestinal issues, affecting 80% of participants, indicating that while it is effective, monitoring for side effects is important.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral semaglutide 50 mg taken once per day in adults with overweight or obesity (OASIS 1): a randomised, double-blind, placebo-controlled, phase 3 trial. Knop, FK., Aroda, VR., do Vale, RD., et al.[2023]

GLP-1 receptor agonists, specifically semaglutide, have been shown to significantly promote weight loss in clinical trials, with superior efficacy compared to placebo and other antidiabetic medications.

The STEP trial demonstrated that a higher dose of semaglutide (2.4 mg, once-weekly) specifically targets obesity, leading to its FDA approval as Wegovy for weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wegovy (semaglutide): a new weight loss drug for chronic weight management. Singh, G., Krauthamer, M., Bjalme-Evans, M.[2022]

In a meta-analysis of six randomized controlled trials involving 3962 overweight or obese individuals, subcutaneous semaglutide 2.4 mg administered weekly resulted in significant and sustainable weight loss, with an average reduction of 11.8% in body weight compared to placebo.

Semaglutide was well tolerated, with the most common side effects being mild to moderate gastrointestinal issues, indicating a favorable safety profile for non-diabetic overweight or obese individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of semaglutide 2.4 mg for weight loss in overweight or obese adults without diabetes: An updated systematic review and meta-analysis including the 2-year STEP 5 trial. Qin, W., Yang, J., Deng, C., et al.[2023]

Semaglutide 2.4 mg, administered weekly, can lead to significant weight loss (average 9.6-17.4% of initial body weight) over 68 weeks, improving obesity-related health issues.

While semaglutide is effective, healthcare providers must evaluate patient suitability carefully, considering factors like safety, potential side effects, and individual health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Insight on Semaglutide for Chronic Weight Management in Adults: Patient Selection and Special Considerations. Chao, AM., Tronieri, JS., Amaro, A., et al.[2023]

In a post hoc analysis of the SUSTAIN 1-3 trials involving 2432 participants with type 2 diabetes, semaglutide significantly reduced body weight (BW) by 3.7 to 6.1 kg compared to comparators, which only saw reductions of 1.0 to 1.9 kg.

The improvement in insulin resistance (IR) was primarily linked to weight loss, with 70% to 80% of the IR reduction from semaglutide 0.5 mg and 34% to 94% from semaglutide 1.0 mg being mediated by the decrease in BW.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reductions in Insulin Resistance are Mediated Primarily via Weight Loss in Subjects With Type 2 Diabetes on Semaglutide. Fonseca, VA., Capehorn, MS., Garg, SK., et al.[2023]

In the STEP clinical trial program, participants with obesity who received once-weekly semaglutide 2.4 mg experienced significant weight loss, averaging between 14.9% and 17.4% over 68 weeks, with 69%-79% achieving at least 10% weight loss compared to only 12%-27% with placebo.

Semaglutide 2.4 mg also led to improvements in cardiometabolic risk factors and had a consistent safety profile, primarily involving gastrointestinal side effects, indicating its potential as an effective treatment for obesity and related health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semaglutide for the treatment of overweight and obesity: A review. Bergmann, NC., Davies, MJ., Lingvay, I., et al.[2023]

In a study involving 2117 participants treated with semaglutide 2.4 mg for 68 weeks, gastrointestinal adverse events (AEs) like nausea and diarrhea were more common than in the placebo group, but these AEs were mostly mild and transient, with only 4.3% of participants discontinuing treatment due to them.

Weight loss with semaglutide was significant and similar in participants with and without GI AEs, indicating that the weight loss effects of semaglutide are largely independent of these gastrointestinal side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gastrointestinal tolerability of once-weekly semaglutide 2.4 mg in adults with overweight or obesity, and the relationship between gastrointestinal adverse events and weight loss. Wharton, S., Calanna, S., Davies, M., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12184113/

Evaluating the efficacy and safety of survodutide for obesity Survodutide effectively reduced relative body weight, absolute body weight, and hemoglobin A1c (P < 0.00001).

2. sciencedirect.com sciencedirect.com/science/article/pii/S2213177924006620

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 body mass index ( ...

3. 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)

4. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/10.1111/dom.70196?af=R

Survodutide for treatment of obesity: Baseline characteristics ... The primary endpoints are percent body weight change and achievement of body weight reduction ≥5% from baseline to Week 76. Efficacy and safety ...

5. dmsjournal.biomedcentral.com dmsjournal.biomedcentral.com/articles/10.1186/s13098-024-01501-x

Effect of survodutide, a glucagon and GLP-1 receptor dual ... The results of this meta-analysis show that Survodutide is effective in reducing weight, BMI and waist circumference, especially with longer interventions and ...

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

Survodutide for the Treatment of Obesity: Rationale and ... Furthermore, the data from SELECT secondary analyses revealed no safety concerns (and a signal toward lower risk of CV death) with semaglutide ...

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

Phase 3 studies survodutide obesity and overweight ... safety study of survodutide in people living with obesity and ... Data shows nearly 19% weight loss in people with overweight or obesity ...