What Is Survodutide?

1. What Is Survodutide?

Survodutide is an investigational once-weekly injection that activates two receptor pathways: glucagon-like peptide-1 (GLP-1) and glucagon. Zealand Pharma’s pipeline record describes it as a long-acting glucagon/GLP-1 receptor dual agonist, formerly called BI 456906, licensed to Boehringer Ingelheim.

Under the licensing agreement, Boehringer Ingelheim is solely responsible for global development and commercialization. Boehringer, Zealand, BI 456906, and survodutide all refer to the same molecule in different sponsor, license, or trial contexts.

Key terminology:

For nearby context, see What Is Mazdutide?, What Is Pemvidutide?, What Is Retatrutide?, and What Is Semaglutide?.

2. Is Survodutide FDA-Approved?

No. Survodutide is not FDA-approved as of October 15, 2026. Zealand Pharma states that survodutide is an investigational compound and that its safety and efficacy have not been evaluated or approved for marketing by any regulatory authority.

Survodutide has received regulatory review designations for MASH, including FDA Fast Track and FDA Breakthrough Therapy Designation for non-cirrhotic MASH with moderate or advanced fibrosis. Zealand also lists EMA PRIME access for MASH with fibrosis, plus breakthrough-designation context in China and Taiwan.

These designations can expedite development discussions and agency reviews, but they do not constitute marketing approval, nor do they create a drug label or dosing schedule.

No regulatory submission for survodutide had been announced as of Zealand’s October 1, 2026 company announcement, which again described survodutide as not approved for use. The same announcement said Boehringer expects to present results from the SYNCHRONIZE-CVOT cardiovascular outcomes trial later in 2026.

3. How Does Survodutide Work?

Survodutide is designed to activate GLP-1 receptors and glucagon receptors. GLP-1 receptor activation is similar to medications like semaglutide, while glucagon receptor activation introduces additional pathways related to energy expenditure and liver biology.

4. What Did the Phase 2 Obesity Trial Show?

The 2024 Lancet Diabetes and Endocrinology Phase 2 trial studied survodutide in adults aged 18 to 75 with a BMI of at least 27 and without diabetes. ClinicalTrials.gov lists the trial as NCT04667377. It enrolled 387 people.

Participants received once-weekly subcutaneous survodutide at 0.6 mg, 2.4 mg, 3.6 mg, or 4.8 mg, or placebo, for 46 weeks. The highest planned dose group had a mean body-weight change of -14.9% at Week 46, compared with -2.8% in the placebo group. The paper also reported that adverse events were more common with survodutide than placebo, primarily gastrointestinal events.

These Phase 2 results supported survodutide’s advancement into larger Phase 3 obesity studies.

5. What Did SYNCHRONIZE-1 Report in 2026?

SYNCHRONIZE-1 is the first Phase 3 obesity trial for survodutide to report results. Boehringer announced topline results on April 28, 2026.

ClinicalTrials.gov lists SYNCHRONIZE-1 as NCT06066515, a Phase 3, randomized, double-blind, placebo-controlled 76-week trial in adults with obesity or overweight without type 2 diabetes. The trial enrolled 726 people and compared weekly survodutide 3.6 mg, survodutide 6.0 mg, and placebo.

Boehringer reported that survodutide met both weight-loss primary endpoints. Using the efficacy estimand, adults treated with survodutide had up to 16.6% average body-weight loss after 76 weeks, compared with 3.2% in the placebo arm. The company also reported that up to 85.1% of adults treated with survodutide reached at least 5% body-weight reduction, versus 38.8% with placebo.

Full results were presented at the ADA 2026 Scientific Sessions and published in the New England Journal of Medicine on June 7, 2026. The paper’s primary analysis used the treatment-regimen estimand, which counts people who stopped the drug or used other obesity medicines. Among 725 randomized participants, mean weight change at Week 76 was -12.2% with 3.6 mg, -13.0% with 6.0 mg, and -5.4% with placebo; 72.6%, 71.9%, and 46.3%, respectively, lost at least 5%. Gastrointestinal adverse events occurred in 80.9%, 89.7%, and 47.9%, and no deaths were reported. The 16.6% figure above comes from the efficacy estimand, which assumes people stayed on treatment.

6. What About SYNCHRONIZE-2, MASLD, and CVOT?

SYNCHRONIZE-1 is part of a broader Phase 3 clinical program spanning multiple populations.

SYNCHRONIZE-2, listed as NCT06066528, studies adults with obesity or overweight and type 2 diabetes. It compares weekly survodutide 3.6 mg, survodutide 6.0 mg, and placebo over 76 weeks. ClinicalTrials.gov lists 755 actual participants and a completed status, with the record verified in August 2026.

SYNCHRONIZE-2 results were presented at EASD 2026 and published in the New England Journal of Medicine on October 1, 2026. Among 752 randomized participants with a mean baseline HbA1c of 7.4%, mean weight change at Week 76 under the treatment-regimen estimand was -8.2% with 3.6 mg, -9.8% with 6.0 mg, and -3.9% with placebo. HbA1c fell by 0.9, 0.8, and 0.2 percentage points, respectively. Gastrointestinal adverse events occurred in 72.8%, 77.7%, and 38.6%. Zealand’s announcement reported up to 13.1% weight loss versus 3.1% with placebo using the efficacy estimand, and treatment discontinuation due to gastrointestinal adverse events in 18% of survodutide-treated participants versus 1.2% with placebo.

SYNCHRONIZE-MASLD, listed as NCT06309992, studies adults with obesity or overweight and confirmed or presumed NASH (the older term still used in some trial records for what is now often called MASH). The trial’s primary endpoints include at least 30% relative liver-fat reduction by MRI-PDFF and relative body-weight change at Week 48. Results published in Nature Medicine in June 2026 showed that both primary endpoints were met in 216 adults randomized 2:1 to survodutide 6.0 mg or placebo: 68.5% versus 28.6% reached at least 30% liver-fat reduction, and body weight changed by -8.7% versus -1.4%, under the treatment-regimen estimand.

SYNCHRONIZE-CVOT, listed as NCT06077864, is an event-driven cardiovascular safety trial. ClinicalTrials.gov lists 5531 actual participants and a completed status, and its primary endpoint is time to first occurrence of a composite cardiovascular endpoint. Results had not been reported as of October 1, 2026, when Zealand said Boehringer expects to present them later in 2026.

7. What Is the MASH Research?

MASH stands for metabolic dysfunction-associated steatohepatitis. It is a fatty-liver disease with inflammation and liver-cell injury, which can progress to fibrosis. The terminology recently changed, so older resources and trial titles frequently use the term NASH.

Survodutide’s MASH clinical program consists primarily of a 2024 Phase 2 study and the ongoing Phase 3 LIVERAGE program.

In the 2024 New England Journal of Medicine Phase 2 trial, 293 treated participants had biopsy-confirmed MASH with fibrosis stage F1 through F3. Participants received once-weekly survodutide 2.4 mg, 4.8 mg, 6.0 mg, or placebo for 48 weeks. The primary endpoint was improvement in MASH with no worsening of fibrosis.

The paper reported MASH improvement without worsening fibrosis in 47% of the 2.4 mg group, 62% of the 4.8 mg group, 43% of the 6.0 mg group, and 14% of the placebo group. Fibrosis improvement by at least one stage occurred in 34%, 36%, 34%, and 22%, respectively.

Common adverse events included nausea, diarrhea, and vomiting, which were more frequent with survodutide than with placebo.

8. What Are LIVERAGE and LIVERAGE-Cirrhosis?

LIVERAGE and LIVERAGE-Cirrhosis are Phase 3 MASH trials.

ClinicalTrials.gov lists LIVERAGE as NCT06632444. It is recruiting adults with noncirrhotic NASH/MASH and F2 to F3 fibrosis. The planned enrollment is 1800. Its Part 1 primary endpoints include MASH resolution without worsening fibrosis and at least a one-stage fibrosis improvement with no worsening of MASH at Week 52.

ClinicalTrials.gov lists LIVERAGE-Cirrhosis as NCT06632457. It is recruiting adults with compensated NASH/MASH cirrhosis. The planned enrollment is 1590. Its primary endpoint is time to first occurrence of a composite clinical endpoint that includes all-cause mortality, liver transplant, hepatic decompensation events, MELD score worsening to at least 15, and progression to clinically meaningful portal hypertension.

While LIVERAGE focuses on noncirrhotic fibrosis, LIVERAGE-Cirrhosis evaluates patients with compensated cirrhosis and tracks longer-term liver-related outcomes.

9. Survodutide vs Mazdutide, Semaglutide, and Retatrutide

Survodutide is often compared to mazdutide because both are GLP-1 and glucagon receptor dual agonists. However, mazdutide has China NMPA approvals (2025), while survodutide does not currently have marketing approval.

Semaglutide is an approved, single-receptor GLP-1 agonist, while retatrutide is a Lilly triple agonist still under Phase 3 study.

10. Summary Characteristics

Key details for survodutide:

11. What Is Survodutide FAQ

• What is survodutide in simple terms?

  Survodutide, formerly BI 456906, is an investigational once-weekly injection designed to activate GLP-1 receptors and glucagon receptors. Boehringer Ingelheim is studying it for obesity, overweight, and MASH.

• Is survodutide FDA-approved?

  No. Zealand Pharma states that survodutide is investigational and has not been approved for marketing by any regulatory authority. FDA Fast Track and Breakthrough Therapy designations for MASH are review-program designations, not approval. As of Zealand's October 1, 2026 announcement, no regulatory submission had been announced, and Boehringer expected to present SYNCHRONIZE-CVOT cardiovascular safety results later in 2026.

• What did SYNCHRONIZE-1 report?

  Boehringer reported that SYNCHRONIZE-1 met both weight-loss primary endpoints. In adults with obesity or overweight without type 2 diabetes, survodutide reached up to 16.6% average body-weight loss at 76 weeks using the efficacy estimand, versus 3.2% with placebo. In the peer-reviewed NEJM paper, the primary treatment-regimen analysis showed 12.2% weight loss with 3.6 mg and 13.0% with 6.0 mg, versus 5.4% with placebo.

• What did SYNCHRONIZE-2 report?

  SYNCHRONIZE-2 tested survodutide 3.6 mg and 6.0 mg against placebo for 76 weeks in 752 randomized adults with obesity or overweight and type 2 diabetes. In NEJM, the treatment-regimen analysis showed 8.2% and 9.8% weight loss versus 3.9% with placebo, and HbA1c fell by 0.9 and 0.8 percentage points versus 0.2 with placebo, from a baseline of 7.4%.

• How is survodutide being studied for MASH?

  Survodutide is being studied for metabolic dysfunction-associated steatohepatitis, or MASH. A 2024 NEJM Phase 2 trial studied biopsy-confirmed MASH with fibrosis, and Phase 3 LIVERAGE trials are now recruiting.

• Is survodutide the same as mazdutide?

  No. Both are GLP-1 and glucagon receptor dual agonists, but they are different molecules from different development programs. Mazdutide has China approvals; survodutide remains investigational as of October 2026.

12. Sources