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Survodutide clears its phase 3 heart-safety trial, with up to 13.7% weight loss in 72 weeks

phase 3 trial in 5,530 adults

Boehringer Ingelheim's glucagon and GLP-1 shot did not raise heart risk in 5,530 high-risk adults, and the company is now preparing to file for approval in obesity.

What happened

Boehringer Ingelheim reported the results of SYNCHRONIZE-CVOT on November 9, 2026, at the American Heart Association's Scientific Sessions in Chicago. The full paper was published the same day in The Lancet.

The phase 3 trial gave 5,530 adults with obesity or overweight a weekly survodutide shot (3.6 mg or 6.0 mg) or a placebo. Everyone in it was at higher heart risk: they had heart disease, kidney disease, or at least two weight-related risk factors.

Survodutide met its main goal. It did not increase major heart events (heart-related death, heart attack, stroke, procedures to open the heart's arteries, or heart failure events) compared with placebo, with a hazard ratio of 0.89.

The other numbers

At 72 weeks, people on survodutide lost up to 13.7% of their body weight, against 2.0% on placebo. That was in a group that included people with type 2 diabetes, who usually lose less.

Waist size came down by up to 11.96 cm, against 2.74 cm on placebo, and systolic blood pressure fell by up to 6.68 mmHg, against 1.76 mmHg. Markers of inflammation (hs-CRP) and blood fats (triglycerides) also dropped.

How it works

Survodutide is a dual agonist: one molecule that acts on both the GLP-1 receptor, which curbs appetite, and the glucagon receptor, which is tied to energy use and fat burning in the liver. Retatrutide hits those two plus a third, GIP.

This is the first heart-safety trial of a glucagon and GLP-1 dual shot to report, which matters because glucagon can raise heart rate. Clearing that bar was the last big step before approval filings.

What it means for you

Another weekly obesity shot is getting closer to pharmacy shelves, with a mechanism aimed at the liver and visceral fat as much as at appetite.

Side effects were mostly stomach-related and mild to moderate: nausea, vomiting, diarrhea and constipation. About 1 in 5 people on survodutide stopped because of them, against about 1 in 50 on placebo, in line with the drug's other trials.

What's next

Boehringer says it is now preparing regulatory submissions for survodutide in obesity, based on the full SYNCHRONIZE program. Separate trials in fatty liver disease (MASH), LIVERAGE and LIVERAGE-Cirrhosis, are still running. Survodutide is not approved anywhere yet.

The numbers

  • 5,530 adults at higher heart risk, phase 3, placebo-controlled
  • No added risk of major heart events (HR 0.89)
  • Up to 13.7% weight loss at 72 weeks vs 2.0% on placebo
  • Waist down up to 11.96 cm; systolic blood pressure down up to 6.68 mmHg
  • Boehringer is preparing approval filings in obesity

The original: The Lancet (SYNCHRONIZE-CVOT) and Boehringer Ingelheim's press release, November 9, 2026

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