Survodutide for Obesity

Not yet recruiting at 15 trial locations
BI
Overseen ByBoehringer Ingelheim
Age: 18+
Sex: Female
Trial Phase: Phase 3
Sponsor: Boehringer Ingelheim
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 tests whether a new medicine, survodutide, can help women lose weight. It targets women who are overweight or obese, going through or having completed menopause, and have unsuccessfully tried dieting. Participants are randomly divided into two groups: one receives survodutide injections, and the other receives a placebo, which resembles the medicine but lacks active ingredients. The trial lasts just over a year, with regular check-ins to monitor weight changes and health impacts. Women with diabetes cannot participate in this study. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new weight-loss treatment.

Will I have to stop taking my current medications?

The trial requires that you have not taken any medication for obesity within 90 days before starting. Other current medications are not specifically mentioned, so it's best to discuss with the trial staff.

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

Research has shown that survodutide is generally safe for weight loss. In one study, many participants lost a significant amount of weight without major problems. About 85% of those taking survodutide lost at least 5% of their body weight. Some experienced minor side effects, but these were not serious enough to discontinue treatment. The studies did not link any major health issues to the drug. However, individual experiences can vary. Prospective trial participants should discuss potential risks with a healthcare provider.12345

Why do researchers think this study treatment might be promising for obesity?

Survodutide is unique because it offers a novel approach to tackling obesity by potentially targeting multiple pathways involved in weight regulation. Unlike traditional treatments focusing mainly on appetite suppression or fat absorption, Survodutide may work by influencing hormone levels that control hunger and energy expenditure. Researchers are excited about this treatment as it could provide more effective and sustainable weight loss solutions compared to current options like lifestyle modifications, or medications such as orlistat and liraglutide.

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

Research has shown that survodutide, which participants in this trial may receive, may aid weight loss in individuals who are overweight or obese. In earlier studies, participants taking survodutide lost more weight than those who did not. This suggests that survodutide could be an effective option for weight management. It influences how the body regulates hunger and energy use, potentially leading to weight loss. While early results are promising, individuals should consider their health and consult a doctor about their options.

Are You a Good Fit for This Trial?

This trial is for women up to age 65 who are overweight or obese, going through or finished with menopause. They must have a BMI of at least 30, or at least 27 plus a weight-related health issue, and have tried dieting before without success. Women with diabetes cannot join.

Inclusion Criteria

Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
I am a woman over 18 years old.
History of at least one self-reported unsuccessful dietary effort to lose body weight
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Exclusion Criteria

Body weight change (self-reported) >5% within 90 days before screening
Glycosylated Haemoglobin A1c (HbA1c) ≥6.5% (≥48 mmol/mol) as measured by the central laboratory at screening
I have type 1 or type 2 diabetes.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive weekly injections of survodutide or placebo and receive advice on diet and physical activity

52 weeks
12 visits (in-person), a few 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 if survodutide injections help menopausal women lose weight compared to placebo (a lookalike injection with no medicine). Participants are randomly assigned to either group and get weekly injections for about a year, along with diet and exercise advice.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Survodutide armExperimental Treatment1 Intervention
Group II: Placebo armPlacebo 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 ...

Here, we report the results of SYNCHRONIZE-1, a phase 3 clinical trial that evaluated the efficacy and safety of survodutide, in addition to a ...

Evaluating the efficacy and safety of survodutide for obesity

The authors reported a mean body weight reduction at the end of the trial of −15.0% for 5 mg, −19.5% for 10 mg, and −20.9% for 15 mg, compared to the placebo ...

Results from Phase III SYNCHRONIZE-1 obesity trial

survodutide achieved significant weight loss of 16.6% participants lost up to an average of 39.2 lb (17.8 kg) from baseline after 76 weeks of ...

Effect of survodutide, a glucagon and GLP-1 receptor dual ...

The results show that Survodutide is effective in reducing weight; BMI and WC which can bring significant health benefits to obese people. The ...

Survodutide Shows Promising Weight Loss and ...

The latest 2026 research found that participants with overweight or obesity taking survodutide experienced nearly 17% weight loss (an average of 39 pounds) ...