| Trial results
Boehringer Ingelheim and its partner Zealand Pharma said on November 9, 2026 that survodutide, a once-weekly injection that activates both the GLP-1 and glucagon receptors, did not increase the risk of major heart events compared with placebo. The result comes from SYNCHRONIZE-CVOT (NCT06077864), a phase 3 trial of 5,530 adults. It was presented at the American Heart Association Scientific Sessions in Chicago and published the same day in The Lancet. Survodutide is not approved anywhere.
The trial enrolled adults with a body mass index of 27 or higher who also had cardiovascular disease or chronic kidney disease, or at least two weight-related conditions or heart disease risk factors. People were randomly assigned to survodutide at 3.6 mg or 6.0 mg once a week, or to placebo, and neither they nor the researchers knew who got which. The trial began in November 2023, and the registry lists it as completed in June 2026. People were followed for a median of 22 months, and 524 sites in 34 countries took part.
The main question was whether survodutide was no worse than placebo for the first of any of these events: death from a cardiovascular cause, a non-fatal heart attack, a non-fatal stroke, a procedure to restore blood flow to the heart, or a heart failure event. That test is called non-inferiority, and the companies say it was met. The hazard ratio, which compares how fast events happened on survodutide against placebo, was 0.89 (95% confidence interval 0.67 to 1.18). A number below 1 points to fewer events on survodutide, but a range running from 0.67 to 1.18 covers both a lower risk and a somewhat higher one. In the Lancet paper, the main event happened in 136 of 3,671 people on survodutide (3.7%) and 76 of 1,836 on placebo (4.1%). The trial set a margin of 1.65 for the upper end of the range, and 1.18 falls inside it.
| Measure | Survodutide | Placebo |
|---|---|---|
| First major heart event, five-part measure (main result) | Hazard ratio 0.89 (0.67 to 1.18) | Reference |
| Share with a first major heart event (Lancet abstract) | 3.7% (136 of 3,671) | 4.1% (76 of 1,836) |
| First major heart event, three-part measure (heart death, heart attack, stroke) | Hazard ratio 0.84 (0.60 to 1.18) | Reference |
| Change in systolic blood pressure at 72 weeks | Down by up to 6.68 mmHg | Down 1.76 mmHg |
| Change in waist size at 72 weeks | Down by up to 11.96 cm | Down 2.74 cm |
| Change in body weight at 72 weeks | Down by up to 13.7% | Down 2.0% |
| Nausea (Lancet abstract) | 48.0% (3.6 mg), 49.0% (6.0 mg) | 12.1% |
| Stopped because of stomach and gut side effects | 19.3% (3.6 mg), 20.8% (6.0 mg) | 1.9% |
The heart-event ratios count everyone as randomized, whether or not they kept taking the medicine. The blood pressure, waist and weight figures describe the effect while people stayed on treatment, and the weight figure includes people with type 2 diabetes. "Up to" is the companies' wording, and the releases do not say which dose produced the larger number. The five-part ratio, event rates, nausea and stopping figures match the Lancet abstract. The three-part ratio matches the Zealand Pharma company announcement but is not in the abstract. The 72-week blood pressure, waist and weight figures are company-reported.
Stomach and gut side effects were the most common problem: nausea, vomiting, diarrhea and constipation, mostly mild to moderate. About 1 in 5 people stopped survodutide because of them, against about 2 in 100 on placebo. Most stopped while the dose was still going up. The companies say the original plan left limited room for slower dose increases, pauses or adjustments, and that the later phase 3b trials use more flexible titration. In the Lancet paper, nausea was reported by 48.0% on 3.6 mg and 49.0% on 6.0 mg against 12.1% on placebo, and vomiting by 31.7% and 34.0% against 4.8%. Any adverse event was reported by about 93% on survodutide and 85.6% on placebo. Serious events were similar across groups (22.5%, 20.8% and 23.9%), and fatal events were 0.9% on each dose and 0.6% on placebo.
The trial found no extra major heart events with survodutide in people at higher heart risk. It does not show that survodutide protects the heart. Both hazard ratios were below 1, but their ranges also include 1, and the trial was designed to test safety, not benefit. It did not compare survodutide with semaglutide or tirzepatide, so the numbers should not be set against results for those medicines. Boehringer calls it the first and only global heart safety trial of a glucagon and GLP-1 dual agonist. Boehringer Ingelheim funded the trial. The Atlas has read the free Lancet abstract, which confirms the main figures above. Subgroup results and full methods are in the full text, which needs registration and which the Atlas has not read.
Boehringer Ingelheim says it is preparing for regulatory submissions in obesity worldwide. Zealand's nine-month report of November 12, 2026 says Boehringer is moving forward with global filings in obesity in 2027, with no month given. Survodutide is licensed from Zealand Pharma, and Boehringer is responsible for its development and sales. More studies are running, including SYNCHRONIZE-T2D, SYNCHRONIZE-START (dose titration, including switching from other GLP-1 medicines), SYNCHRONIZE-HERA and ELEVATE-LIVER. For MASH, a liver disease, survodutide has FDA Fast Track and Breakthrough Therapy designations, and two phase 3 trials, LIVERAGE and LIVERAGE-Cirrhosis, are under way. The survodutide page has the wider program, including the earlier weight loss trials.
Worth knowing: These are company-reported figures from press releases by Boehringer Ingelheim and Zealand Pharma, and the Atlas has not read the Lancet paper. A heart safety trial asks whether a medicine adds heart risk across a group of people. It does not tell any one person whether to take it. Survodutide is an investigational medicine.
Related: Survodutide medicine page | Pipeline | Trial results | Foundayo sleep apnea results from the same session
Sources: Boehringer Ingelheim press release, November 9, 2026; Zealand Pharma company announcement No. 55/2026, November 9, 2026; Bozkurt B et al., The Lancet, 2026 (abstract read); ClinicalTrials.gov, NCT06077864; Zealand Pharma nine-month report, November 12, 2026 (cited for the 2027 filing timing).