Survodutide is the glucagon-plus-GLP-1 drug furthest along outside China, and in the past week it gained its second published phase 3 obesity trial. It is not approved and has not been filed — its heart-safety trial finished in June and has not reported. This page reads what is registered, published and announced, as of 5 October 2026.
What it does against the two drugs it is most often compared with is on survodutide vs tirzepatide — SYNCHRONIZE-1 in full, the placebo effect, the dose finding — and survodutide vs retatrutide, which covers the liver record. This page does not repeat them; it covers the programme.
The newest result: SYNCHRONIZE-2, adults with type 2 diabetes
Published in the New England Journal of Medicine on 1 October 2026 (DOI 10.1056/NEJMoa2607219, NCT06066528), SYNCHRONIZE-2 randomised 752 adults with type 2 diabetes and a BMI of at least 27 — mean age 55.7, mean BMI 36.5 — to weekly survodutide 3.6 mg, 6.0 mg or placebo for 76 weeks.
| Week 76, treatment-regimen estimand | 3.6 mg (n=250) | 6.0 mg (n=251) | Placebo (n=251) |
|---|---|---|---|
| Weight change | −8.2% | −9.8% | −3.9% |
| Lost ≥5% of body weight | 57.6% | 64.5% | 35.1% |
| HbA1c change (baseline 7.4%) | −0.9 points | −0.8 points | −0.2 points |
| Any gastrointestinal adverse event | 72.8% | 77.7% | 38.6% |
From the published abstract (PubMed 42820639). The treatment-regimen estimand counts every randomised participant whether or not they stayed on the drug.
Three things in that table are worth stating plainly.
- People with diabetes lost less. Placebo-adjusted at 6.0 mg, the difference is 5.9 points, against 7.6 points in SYNCHRONIZE-1's adults without diabetes — about 78% as large (our arithmetic from both papers). CagriSema's programme showed the same direction, at about 60% — see CagriSema.
- The higher dose did not lower HbA1c further (−0.8 against −0.9 points), while adding 1.6 points of weight loss.
- Stopping for side effects was common. Boehringer Ingelheim's announcement put discontinuation for gastrointestinal events at 18% on survodutide against 1.2% on placebo.
Why the headline numbers come in two sizes
Boehringer Ingelheim's release on the same morning was headlined "up to 13.1% weight loss" against 3.1% on placebo. That is the efficacy estimand — what the trial estimates would have happened had everyone kept taking the drug. The journal's primary figure for the same dose is 9.8%. Both are legitimate; they answer different questions. The first describes the drug in people who tolerate it; the second describes what happened to the people who started it, which is closer to what a prescription delivers. Any comparison with another drug has to use the same estimand on both sides — the reason our comparison pages state which one each figure uses.
The programme: 29 registered studies
On 5 October 2026 ClinicalTrials.gov returned 29 studies listing survodutide as an intervention: 14 phase 1, 3 phase 2 and 12 phase 3. Boehringer Ingelheim sponsors 28; one is run by University Medical Center Groningen. Two studies have posted results on the registry, and both are phase 2 — the dose-finding obesity trial (NCT04667377) and the MASH biopsy trial (NCT04771273). None of the completed phase 3 trials had posted registry results; their findings so far have appeared as journal papers and company releases.
| Phase 3 trial | Population | Size | Registry status (5 Oct 2026) |
|---|---|---|---|
| SYNCHRONIZE-1 (NCT06066515) | obesity, no diabetes | 726 | completed; published Aug 2026 |
| SYNCHRONIZE-2 (NCT06066528) | obesity with type 2 diabetes | 755 | completed; published 1 Oct 2026 |
| SYNCHRONIZE-CVOT (NCT06077864) | cardiovascular safety | 5,531 | completed June 2026; no results posted |
| SYNCHRONIZE-MASLD (NCT06309992) | obesity with liver disease | 218 | completed; published 2026 |
| China (NCT06214741) | obesity, Chinese adults | 307 | completed July 2025 |
| Japan, SYNCHRONIZE-JP (NCT06176365) | obesity disease, Japanese adults | 274 | completed Dec 2025 |
| LIVERAGE (NCT06632444) | MASH, fibrosis F2–F3 | ~1,800 | recruiting; primary completion Dec 2031 |
| LIVERAGE-Cirrhosis (NCT06632457) | MASH with compensated cirrhosis | ~1,590 | recruiting; primary completion Jun 2029 |
| Type 2 diabetes (NCT07754461) | blood-sugar control | 600 | recruiting since Aug 2026 |
| SYNCHRONIZE-HERA (NCT07850050) | peri- and post-menopausal women | 600 | not yet recruiting |
| SYNCHRONIZE-START (NCT07855900) | starting fresh or switching from semaglutide or tirzepatide | 350 | not yet recruiting |
| ELEVATE-LIVER (NCT07850063) | heart structure in obesity with liver disease | 600 | not yet recruiting |
ClinicalTrials.gov API v2, queried 5 October 2026; sizes are actual or anticipated enrolment as registered.
The trial that decides the timeline is the heart-safety study. SYNCHRONIZE-CVOT is event-driven, testing non-inferiority on a five-part composite (cardiovascular death, stroke, heart attack, coronary revascularisation and heart-failure events) over up to 114 weeks. Its registry record was last updated on 30 September 2026 and still shows no results. Glucagon raises heart rate, which is why the question is asked compound by compound; the dual-agonist heart-rate record is discussed on survodutide vs retatrutide.
The newest registrations say something about intended use. SYNCHRONIZE-START is an open-label pragmatic study of starting survodutide either new or by switching from semaglutide or tirzepatide — the question a drug expecting to enter a market already served by those two would need answered.
Regulatory status
| Item | Status | Source |
|---|---|---|
| FDA approval | none; no Drugs@FDA entry | openFDA, 5 Oct 2026 |
| Fast Track designation | May 2021 | Boehringer Ingelheim, 1 Oct 2026 |
| Breakthrough Therapy designation | September 2024, non-cirrhotic MASH with F2–F3 fibrosis | Boehringer Ingelheim, 1 Oct 2026 |
| Regulatory submission | none announced | Boehringer Ingelheim, 1 Oct 2026 |
Boehringer Ingelheim's release states that it is "solely responsible for development and commercialization globally" under its licence from Zealand Pharma. A designation shapes how FDA reviews a future application; it is not an approval. The liver-disease context is on GLP-1 drugs for fatty liver.
What cannot be said yet
There is no label, so no approved dose, no official adverse-reaction table and no price. There is no cardiovascular outcome result. There is no trial against tirzepatide or semaglutide; the closest is SYNCHRONIZE-START's switching study, which has no comparator arm. Survodutide sold online is not a medicine; FDA's position on unapproved GLP-1 products is set out on can you buy a GLP-1 over the counter?. The molecule's entry on Peptide Lexicon is its survodutide page, and the other pipeline drugs are on retatrutide, CagriSema and mazdutide.
Sources
Wharton S, le Roux CW et al. (SYNCHRONIZE-2), "Survodutide Once Weekly in Adults with Obesity and Type 2 Diabetes", N Engl J Med 2026, DOI 10.1056/NEJMoa2607219, PubMed 42820639 · Boehringer Ingelheim press release, 1 October 2026 (GlobeNewswire) · ClinicalTrials.gov API v2, all studies listing survodutide, and records NCT06077864, NCT06632444, NCT07754461, NCT07850050, NCT07855900, NCT07850063 · openFDA Drugs@FDA query. All read 5 October 2026.