600 Participants NeededMy employer runs this trial

Survodutide for Type 2 Diabetes

Recruiting at 125 trial locations
BI
Overseen ByBoehringer Ingelheim
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Boehringer Ingelheim
Must be taking: Metformin, Sulfonylurea, SGLT2i, Insulin
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a new medicine, survodutide, can help people with type 2 diabetes manage their blood sugar levels. Researchers will divide participants into three groups based on their current diabetes treatment: healthy eating and exercise, diabetes tablets, or insulin injections. Within these groups, participants will receive either a low or high dose of survodutide or a placebo (a substance with no active medication) once a week. Individuals with type 2 diabetes and a body mass index (BMI) of 23 or higher may be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking diabetes treatment.

Do I have to stop taking my current medications for the trial?

The trial does not require you to stop your current diabetes medications. Participants continue their regular diabetes treatment during the study.

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

Previous studies have shown promising results for survodutide. Research suggests it aids weight loss and blood sugar control in people with obesity and type 2 diabetes. Specifically, survodutide lowered HbA1c levels, a measure of blood sugar control, and helped participants with type 2 diabetes lose weight.

Regarding safety, past research indicates that survodutide is generally well-tolerated. Some studies reported stomach and intestinal side effects, such as nausea, which were dose-related. However, these effects were manageable and did not lead to many participants dropping out.

While researchers continue to study survodutide for type 2 diabetes, ongoing research is in the later stages. This typically means a substantial amount of safety information is already available. These later-phase trials usually involve more participants to confirm both the treatment's effectiveness and safety.12345

Why do researchers think this study treatment might be promising?

Survodutide is unique because it offers a novel approach to managing Type 2 Diabetes by potentially enhancing weight loss and improving blood sugar control. Unlike traditional treatments such as metformin or insulin, which primarily focus on controlling blood sugar levels, survodutide is a dual agonist targeting both the glucagon and GLP-1 receptors. This dual action could lead to better regulation of glucose levels and more effective weight management, which is a crucial aspect of Type 2 Diabetes care. Researchers are excited about survodutide because it could provide a more comprehensive treatment option by addressing both blood sugar levels and weight, two critical factors in managing diabetes.

What evidence suggests that survodutide might be an effective treatment for type 2 diabetes?

Research has shown that survodutide can help control blood sugar in people with type 2 diabetes. One study found that survodutide lowered glycated hemoglobin levels, indicating a reduction in long-term blood sugar levels. Additionally, survodutide has been linked to weight loss, with some patients losing up to 14.9% of their body weight over time. This weight loss can aid in managing type 2 diabetes, as weight control is often crucial. Overall, these findings suggest that survodutide may be a good option for managing blood sugar and weight in people with type 2 diabetes. Participants in this trial will receive either low-dose or high-dose survodutide, or a placebo, as an addition to their current treatment regimen.14678

Are You a Good Fit for This Trial?

This trial is for adults with type 2 diabetes who have a BMI of 23 or higher. Participants can be on healthy lifestyle changes, diabetes pills, or insulin (with or without pills).

Inclusion Criteria

I am willing and able to self-inject the study drug and follow all study instructions.
Women of childbearing potential must be ready and able to use highly effective birth control methods with failure rate <1% per year when used consistently and correctly
Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to trial admission
See 3 more

Exclusion Criteria

I have not had or planned obesity surgery or weight loss device use during the trial period.
I understand there may be other reasons I cannot join this study.
I have type 1 diabetes or latent autoimmune diabetes in adults.
See 6 more

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 placebo as an adjunct to their current diabetes treatment regimen

56 weeks
12 visits (in-person), 9 phone calls

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Survodutide

Trial Overview

The study tests whether survodutide injections help control blood sugar compared to placebo. People are randomly assigned to get either survodutide at different doses or placebo once a week, while continuing their usual diabetes treatment.

How Is the Trial Designed?

9

Treatment groups

Experimental Treatment

Placebo Group

Group I: Part C: Low-dose survodutideExperimental Treatment1 Intervention
Group II: Part C: High-dose survodutideExperimental Treatment1 Intervention
Group III: Part B: Low-dose survodutideExperimental Treatment1 Intervention
Group IV: Part B: High-dose survodutideExperimental Treatment1 Intervention
Group V: Part A: Low-dose survodutideExperimental Treatment1 Intervention
Group VI: Part A: High-dose survodutideExperimental Treatment1 Intervention
Group VII: Part A: PlaceboPlacebo Group1 Intervention
Group VIII: Part B: PlaceboPlacebo Group1 Intervention
Group IX: Part C: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials
2,566
Recruited
16,150,000+

Citations

Survodutide Once Weekly for the Treatment of Adults with ...

... 2 trial involving persons with obesity and type 2 diabetes showed that survodutide significantly reduced glycated hemoglobin levels.

Dose–response effects on HbA 1c and bodyweight reduction ...

multiple ascending doses of survodutide over 16 weeks produced mean bodyweight decreases of up to 14.1% (2.4 mg survodutide twice weekly [biw] ...

Phase II clinical trial weight loss results

After 46 weeks of treatment, up to 40% of people who reached the highest two doses of survodutide achieved a weight loss of at least 20%, ...

2 Randomized Phase 3 Trial of Survodutide, a Glucagon ...

Conclusions: SYNCHRONIZE-2 will determine the efficacy, safety and tolerability of survodutide for BW reduction in people with obesity and T2D, ...

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 ( ...

survodutide-phase-3-fat-loss-obesity-dual-agonist-data

Sustained weight loss of up to an average of 16.6% 2 ・ had liver fat reduction of up to 63.1% further demonstrating survodutide's potential to ...

Evaluating the efficacy and safety of survodutide for obesity

Lower death rates were observed in patients receiving survodutide, making it a preferred option over both semaglutide and tirzepatide. In this review, we aim to ...

Survodutide reduces body weight in phase 2 dose-finding ...

A majority (55%) of the participants receiving survodutide 4.8 mg achieved ≥15% body weight loss. The tolerability profile of survodutide was ...