Survodutide: evidence, FDA status and research

A weekly injection, not yet approved, being tested for weight loss and fatty liver. In trials people lost up to 16.6% of body weight, versus 3.2% on a dummy shot.

Sold for

Survodutide is talked about as the next-generation weight-loss injection that also burns liver fat, a possible rival to semaglutide and tirzepatide.

Studies say

Randomized trials show large placebo-adjusted weight loss and liver-fat reduction, but the drug is unapproved and long-term outcome data do not yet exist, which is why it grades B.

Why grade B. Survodutide has a published phase 2 randomized trial in metabolic dysfunction-associated steatohepatitis (293 participants), a 216-person phase 3 liver-fat trial published in Nature Medicine, and phase 3 obesity results (SYNCHRONIZE-1, 725 participants, the largest) reported by the sponsor in 2026. The obesity use it is best known for rests on randomized placebo-controlled data, but the drug has no approval and the full phase 3 program is still reading out, so it stops at B. ¹³⁴

FDA. Survodutide is not approved by the FDA or any other regulator. It is an investigational drug in phase 3 trials run by Boehringer Ingelheim and Zealand Pharma. ⁴

Written from 4 cited sources. Fact-checked 2026-10-27: 20 claims checked, 6 corrected. Last refreshed 2026-10-27. Not physician reviewed.

What this means for you

What people take it for: Losing weight and clearing fatty liver disease.
Can a US doctor prescribe it?: Not yet; it is still in trials.
Properly tested in people?: Partly: some human trials, with gaps: a 293-patient liver trial and a 725-adult weight trial. Long-term results are not in.

Evidence checklist

Randomised controlled trial Phase 2 MASH and phase 3 placebo-controlledyes
Human study over 100 people Phase 2 MASH trial 293 adultsyes
More than one research group Boehringer Ingelheim and Zealand programno
Clinical outcomes, not surrogate markers Weight and liver histology, not outcomesno
Human safety data beyond case reports Higher dropout in phase 2; no long-term datano

Drawn from the cited studies below. A dash means the sources give no information.

What it is

Survodutide (formerly BI 456906) is a synthetic peptide built on the glucagon backbone that activates two receptors at once: the glucagon receptor and the GLP-1 receptor. GLP-1 is the gut hormone that semaglutide and liraglutide imitate; it slows stomach emptying, lowers appetite and raises insulin after meals. Glucagon is the hormone the pancreas releases between meals to raise blood sugar, and it also increases energy expenditure and fat breakdown in the liver. ¹²

The drug is given by injection under the skin. It is being developed for obesity and for metabolic dysfunction-associated steatohepatitis (MASH), the inflammatory form of fatty liver disease. It is not for sale legally anywhere, and anything marketed online under the name is not the trial product. ¹⁴

How it works

Activating the GLP-1 receptor reduces food intake, which drives most of the weight loss. Adding glucagon receptor activity is meant to raise calorie burning and pull fat out of liver cells, an effect single GLP-1 drugs do not have directly. The trade-off is that glucagon raises blood sugar, so the molecule is balanced so that the GLP-1 effect on insulin outweighs it; the phase 2 MASH trial reported no worsening of glucose control. ¹²

What human research shows

In the phase 2 MASH trial published in the New England Journal of Medicine, 293 adults with biopsy-confirmed MASH and fibrosis were randomized to one of three survodutide doses or placebo for 48 weeks. Improvement in MASH without worsening of fibrosis occurred in 47, 62 and 43 percent of participants on the low, middle and high doses, against 14 percent on placebo. Nausea (66 versus 23 percent), diarrhea and vomiting were more common on survodutide. Weight fell by roughly 10 percent at the trial dose against about 1 percent on placebo. ¹

SYNCHRONIZE-1, the phase 3 obesity trial, randomized 725 adults with obesity or overweight and no diabetes to survodutide at two doses or placebo for 76 weeks. The sponsor reported mean weight loss of up to 16.6 percent on survodutide and 3.2 percent on placebo, with up to 85 percent of treated participants losing at least 5 percent of body weight, against 39 percent on placebo. SYNCHRONIZE-MASLD, a phase 3 trial in 216 adults with obesity and fatty liver disease published in Nature Medicine in 2026, reported that 84 percent of survodutide participants cut liver fat by at least 30 percent at 48 weeks, against 24 percent on placebo. ³⁴

Study	Model	Finding
Phase 2 MASH trial (NEJM 2024)	Humans, n=293, randomized placebo-controlled, 48 weeks	MASH improved without fibrosis worsening in 43 to 62 percent across the three doses (best at the middle dose) versus 14 percent on placebo. ¹
SYNCHRONIZE-1 (phase 3 obesity)	Humans, n=725 adults with obesity or overweight without diabetes, randomized placebo-controlled, 76 weeks	Mean weight loss of up to 16.6 percent on survodutide versus 3.2 percent on placebo, per the sponsor's topline release. ⁴
SYNCHRONIZE-MASLD (Nature Medicine 2026)	Humans, n=216 adults with obesity and at-risk MASLD, randomized placebo-controlled phase 3, 48 weeks	84.2 percent of survodutide participants achieved a 30 percent or greater relative reduction in liver fat versus 24.3 percent on placebo, with 12.2 percent weight loss versus 1.0 percent. ³

Safety

The side effects in trials were the ones shared by all GLP-1 drugs: nausea, vomiting, diarrhea and constipation, worst during dose escalation. In the phase 2 MASH trial, 20 percent of participants on the highest dose stopped because of adverse events, against 3 percent on placebo, which is higher than seen with approved GLP-1 drugs and a point regulators will weigh. ¹

Nobody has long-term safety data for survodutide. Cardiovascular outcomes, effects on muscle mass over years, and what happens after stopping are all unknown. Gallbladder events and heart-rate increases are known class effects of GLP-1 agonists and were seen in the glucagon dual-agonist class, but survodutide-specific rates will come from the full phase 3 publications. ¹²

Questions for your clinician

Is there a trial of survodutide I could join?
How do approved obesity drugs compare for me?
What does the higher dropout rate for side effects mean?

Questions people ask

Is survodutide approved anywhere?

No. It is an investigational drug. Boehringer Ingelheim has reported phase 3 results and is expected to file with regulators, but as of October 2026 there is no approved product in any country. ⁴

How is survodutide different from semaglutide?

Semaglutide acts on the GLP-1 receptor only. Survodutide acts on the GLP-1 receptor and the glucagon receptor. The glucagon activity is meant to increase energy expenditure and reduce liver fat, which is why the drug is also being studied for fatty liver disease. ¹²

Does survodutide work for fatty liver disease?

In a 48-week phase 2 trial of 293 people with MASH and fibrosis, the inflammatory liver disease improved without worsening scarring in 43 to 62 percent of those on survodutide, depending on dose, versus 14 percent on placebo. A 2026 phase 3 trial in Nature Medicine reported that most treated participants cut liver fat by at least 30 percent. Both are surrogate endpoints; whether the drug prevents cirrhosis or liver-related death is unknown. ¹³

How well do patients tolerate it?

Nausea, vomiting, diarrhea and constipation, mostly during the first months as the dose rises. Discontinuation for side effects was higher than placebo in the phase 2 trial. Long-term risks have not been studied. ¹

Citations

Sanyal 2024, NEJM: A phase 2 randomized trial of survodutide in MASH and fibrosis doi.org
StatPearls: Glucagon-like peptide-1 receptor agonists ncbi.nlm.nih.gov
Kaplan 2026, Nature Medicine: survodutide in obesity with MASLD (SYNCHRONIZE-MASLD), phase 3 doi.org
Boehringer Ingelheim 2026: SYNCHRONIZE-1 phase 3 obesity trial results (press release) boehringer-ingelheim.com