Loading
Obesity / survodutide · Phase 3 Trial
ClinicalTrials.gov · August 11, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 3 randomized controlled trial of survodutide for cardiovascular safety in 5531 adults with overweight or obesity and cardiovascular or chronic kidney disease, powered to demonstrate non-inferiority on a composite cardiovascular outcome. The registry record indicates recruitment is complete but no results are posted, so the efficacy, safety, or clinical significance of the intervention cannot yet be assessed.
Phase 3, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose. Obesity; age from 18 Years. Intervention: survodutide 3.6 mg; survodutide 6.0 mg. Compared with: Placebo — Placebo Comparator. n = 5,531. 539 sites across 35 countries.
This is a Phase 3 randomized controlled trial of survodutide for cardiovascular safety in 5531 adults with overweight or obesity and cardiovascular or chronic kidney disease, powered to demonstrate non-inferiority on a composite cardiovascular outcome. The registry record indicates recruitment is complete but no results are posted, so the efficacy, safety, or clinical significance of the intervention cannot yet be assessed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
Once results are published, this trial will provide critical safety data on survodutide's cardiovascular effects in a high-risk population. A non-inferiority result would support use in patients with obesity and comorbidities; any signal of cardiovascular harm would warrant caution.
Phase 3 cardiovascular outcomes trial with completed enrollment but no results posted in this registry record; the study design is rigorous but evidence cannot be assessed without outcome data.
As stated by the source record.
Quoted from the source exactly as published.
Once results are published, this trial will provide critical safety data on survodutide's cardiovascular effects in a high-risk population. A non-inferiority result would support use in patients with obesity and comorbidities; any signal of cardiovascular harm would warrant caution.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06077864). This is a study registration, not published results. Lead sponsor: Boehringer Ingelheim. Recruitment status: COMPLETED. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 5531 participants (ACTUAL). Conditions: Obesity. Interventions: COMBINATION_PRODUCT: survodutide; COMBINATION_PRODUCT: Placebo. Primary outcome measures: 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. Brief 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.