Zealand Pharma announces Boehringer Ingelheim’s novel glucagon/GLP-1 dual agonist survodutide achieved significant weight loss of 16.6% delivering meaningful metabolic improvement in people with obesity or overweight in Phase 3 trial

Company announcement – No. 10 / 2026

Zealand Pharma announces Boehringer Ingelheim’s novel glucagon/GLP-1 dual agonist survodutide achieved significant weight loss of 16.6% delivering meaningful metabolic improvement in people living with obesity or overweight in Phase 3 trial

• In SYNCHRONIZE-1, participants lost up to an average of 39.2 lb (17.8 kg) from baseline after 76 weeks of treatment with survodutide, a glucagon/GLP-1 receptor dual agonist¹
• The trial met both weight loss primary endpoints and its key secondary endpoint evaluating waist circumference, a predictor of cardiometabolic risk, together demonstrating survodutide’s potential to broadly improve metabolic health¹
• In addition to these positive results, Boehringer is advancing its broad metabolic health R&D program, exploring multiple pharmaceutical approaches to weight management including oral treatments.
• Survodutide is licensed to Boehringer Ingelheim from Zealand Pharma, with Boehringer Ingelheim solely responsible for the global development and commercialization of survodutide.

Copenhagen, Denmark, April 28, 2026 – Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078), a biotechnology company transforming the future of metabolic health, today announced that Boehringer Ingelheim has reported positive topline results from the Phase III SYNCHRONIZE-1 trial, in which survodutide (BI 456906) met the co-primary endpoints using both the efficacy and treatment-regimen estimands.^*† Adults living with obesity or overweight, without type 2 diabetes, who were treated with survodutide experienced sustained weight loss of up to an average of 16.6% after 76 weeks using the efficacy estimand, a statistically significant decrease versus 3.2% in the placebo arm (p<0.0001).¹ This level of weight loss supports survodutide’s potential as a clinically meaningful treatment option for people living with obesity or overweight.¹   Full data from the Phase III trial will be presented at the upcoming American Diabetes Association’s (ADA) 2026 Scientific Sessions in June. 

Zealand Pharma is eligible for high single to low double-digit percentage royalties on global sales of survodutide and EUR 315 million in potential outstanding milestone payments. 

“We are highly encouraged by the SYNCHRONIZE-1 topline results announced today by Boehringer Ingelheim, supporting the promise of survodutide as a differentiated therapy for people living with overweight or obesity and associated metabolic dysfunction,” said David Kendall, MD, Chief Medical Officer of Zealand Pharma. “We look forward to the planned disclosure of the full data from SYNCHRONIZE-1 and SYNCHRONIZE-MASLD trials at the upcoming ADA 2026 Scientific Congress.”

The trial met its other co-primary endpoint, with up to 85.1% of adults treated with survodutide achieving a body weight reduction of ≥5% after 76 weeks of treatment, using the efficacy estimand, versus 38.8% in the placebo arm (p<0.0001).¹ Initial analysis indicates that body weight reduction with survodutide was driven predominantly by loss of fat tissue, with lean mass contributing only a small proportion of total weight.¹

In a key secondary endpoint, adults treated with survodutide experienced a statistically significant reduction in waist circumference – a clinical marker closely linked to visceral fat and cardiometabolic risk² – after 76 weeks versus placebo.¹ Excess visceral fat, particularly around the abdomen, is a known contributor to metabolic dysfunction and is closely connected to impaired liver function.³ As a dual glucagon/GLP‑1 receptor agonist,⁴ survodutide has the potential to address obesity while also supporting liver function, a key regulator of metabolic health.¹

“I am encouraged by the data emerging from SYNCHRONIZE-1, which continue to demonstrate survodutide’s potential as a clinically meaningful treatment option for people with the disease of obesity,” said Professor Carel le Roux, M.D., Ph.D., Professor at University College in Dublin, Ireland, and Global Coordinating Investigator of the trial. “There is an urgent need for new therapies that go beyond weight reduction alone to support meaningful improvements in metabolic health. Survodutide’s dual agonism is particularly exciting, as it offers a promising approach to addressing this significant unmet need in care.”

Obesity is a chronic, complex metabolic disease that impacts more than 1 in 8 people worldwide in many different ways, and can have serious long-term consequences.^5,6 It is closely linked to serious conditions including liver disease, type 2 diabetes and cardiovascular disease.^7,8 Notably, up to 1 in 3 people living with obesity develop a serious liver condition called metabolic dysfunction-associated steatohepatitis (MASH), characterized by inflammation and liver damage.⁹

“Today’s SYNCHRONIZE-1 topline results strengthen our confidence in survodutide as a treatment candidate capable of addressing obesity and potentially offering targeted weight loss to help address connected conditions including liver disease,” said Shashank Deshpande, Chairman of the Board of Managing Directors and Head of Human Pharma, Boehringer Ingelheim. “Survodutide has the potential to be the first global glucagon/GLP-1 dual agonist to help the more than 1 billion people living with obesity and MASH.”

Survodutide’s GLP‑1 agonism decreases appetite while increasing fullness and satiety,¹⁰ while its glucagon agonism is thought to directly act on the liver to reduce hepatic fat, regulate metabolic function, resolve inflammation, and improve fibrosis.^11,12,13

As expected with GLP-1 based therapies, participants in the trial experienced gastrointestinal events, with discontinuations happening more frequently during the dose escalation phase.¹ These events were both mild to moderate in severity and temporary, with no new safety concerns observed outside of what is expected for the GLP-1 class.

Survodutide is an investigational agent and has not been approved for use; its efficacy and safety has not been established. SYNCHRONIZE-1 is part of a comprehensive global Phase III obesity program, evaluating survodutide in people living with overweight and obesity, among key sub-populations.¹⁴ Additional trial results are expected to read out during 2026. Survodutide is also being studied in two global Phase III clinical trials LIVERAGE and LIVERAGE-Cirrhosis investigating the efficacy and safety of survodutide in adults with MASH and fibrosis stages 2 or 3 and in those with compensated MASH cirrhosis (fibrosis stage 4).^15,16

Survodutide is the first in a broader portfolio of therapies being developed for people living with obesity or obesity and connected metabolic health conditions, with multiple approaches under investigation. This includes an investigational, potential first-in-class triple GLP-1, GIP, NPY2 receptor agonist peptide (BI 3034701), which will be entering Phase II in the middle of 2026, as well as additional experimental approaches including oral treatment options.

About obesity and overweight
In 2016, more than 1.9 billion adults lived with overweight — defined as a body mass index (BMI) of 25 or more.⁵ Of these, over 650 million were living with obesity — defined as a BMI of 30 or more.⁵ More than one billion people around the world are living with obesity today (1 in 8 of us) – and by 2030, that number could be more than double what it was in 2010.¹⁷Overweight and obesity are complex chronic conditions involving abnormal or excessive fat accumulation that present a risk to a person’s overall health.

About metabolic dysfunction-associated steatohepatitis (MASH)
MASH is a chronic and progressive liver disease caused by a build-up of fat in the liver,^18,19 and is a more severe form of metabolic dysfunction-associated steatotic liver disease (MASLD).²⁰ In the U.S., cases of MASH are predicted to rise by 63% between 2015 and 2030, from 16.5 million to 27.0 million cases.²¹ MASH is a disease closely associated with interconnected cardiovascular, renal and metabolic conditions,^22,23  and it is estimated that 34% of people living with obesity also have MASH.⁹

About survodutide (BI 456906) 
Survodutide is a glucagon/GLP-1 receptor dual agonist that activates both the glucagon and GLP-1 receptors, which play a role in controlling metabolic functions.^11,12,13 Survodutide is being evaluated in a robust Phase III clinical development program, including the SYNCHRONIZE studies for people living with overweight or obesity,^{24,25,26,27,28,29} and the LIVERAGE studies for people living with MASH and fibrosis.^15,16

Survodutide has potential to treat adults with non-cirrhotic MASH and moderate or advanced fibrosis (stages 2 or 3) and has been recognized by the U.S. FDA, which granted it: 

• Fast Track designation in May 2021 and;³⁰

• Breakthrough Therapy designation in September 2024.³¹

Survodutide’s potential to treat adults with MASH and fibrosis has also been recognized by: 

• the European Medicines Agency (EMA), through acceptance to its PRIME scheme in November 2023 and;³²

• the Center for Drug Evaluation of China’s National Medical Products Administration (NMPA) which granted it Breakthrough Therapy designation in June 2024 and;
• the Taiwan Food and Drug Administration which granted it Breakthrough Designation in September 2024.

Survodutide is licensed to Boehringer Ingelheim from Zealand Pharma, with Boehringer solely responsible for development and commercialization globally. Survodutide is part of Boehringer Ingelheim’s research and development portfolio in the cardiovascular, renal and metabolic disease areas.

About the SYNCRHONIZE-1 trial (NCT06066515)
This is a Phase III, double-blind, placebo-controlled 76-week efficacy and safety trial of survodutide among 725 adults living with obesity or overweight, without type 2 diabetes.²⁴ Participants received a weekly injection of survodutide at either a 3.6mg or 6.0mg dose, or placebo.²⁴ The primary endpoints of the trial are the percentage change in body weight from baseline to Week 76, and an achievement of body weight reduction ≥5% from baseline to Week 76.²⁴

There are 31 secondary endpoints, including, achievement of ≥10, ≥15%, and ≥20% body weight reduction, and absolute changes from baseline to Week 76 in:²⁴

• Body weight
• Waist circumference
• Blood pressure
• Body Mass Index (BMI)
• Glycosylated hemoglobin A1c (HbA1c)
• Total cholesterol
• Liver fat content

About the SYNCHRONIZE program 
Survodutide is also being evaluated in three other global Phase III studies for people living with overweight or obesity among key sub-populations.

• SYNCHRONIZE-2 enrolled a sub-population of adults with type 2 diabetes.²⁵
• SYNCHRONIZE-MASLD enrolled a sub-population of adults with a confirmed or presumed diagnosis of MASH.²⁷
• SYNCHRONIZE-CVOT enrolled a sub-population of adults with cardiovascular disease, chronic kidney disease, or with risk factors for cardiovascular disease.²⁶

Survodutide is also being explored in two Phase III in-market trials:

• SYNCHRONIZE-JP in Japan and SYNCHRONIZE-CN in China are exploring survodutide for sub-populations of people living with obesity.^28,29 SYNCHRONIZE-JP explores the relative change in liver fat and body composition parameters from baseline to Week 76 when treated with survodutide versus placebo, as a secondary endpoint.²⁸

About LIVERAGE and LIVERAGE-Cirrhosis 
LIVERAGE and LIVERAGE-Cirrhosis are global Phase III clinical trials investigating the efficacy and safety of survodutide in adults with MASH and fibrosis stages 2 or 3 and in those with compensated MASH cirrhosis (fibrosis stage 4), respectively.^15,16

LIVERAGE will enroll approximately 1,800 adults, and LIVERAGE-Cirrhosis will enroll approximately 1,590 adults. In each trial, participants are randomized to receive weekly injections of either survodutide, reaching a maximum dose of 6 mg, or placebo.^15,16

About Boehringer Ingelheim
Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry’s top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,300 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at www.boehringer-ingelheim.com/uk (UK and Ireland) or www.boehringer-ingelheim.com (rest of world).

* The efficacy estimand is the estimated treatment effect assuming patients remained on treatment for the entire study duration. P-values for efficacy estimand are nominal.
^†  The treatment-regimen estimand is the estimated treatment effect, regardless of whether the patient adheres to the treatment, discontinues, or initiates other therapies.

About Zealand Pharma
Zealand Pharma A/S (Nasdaq: ZEAL) is a biotechnology company focused on advancing medicines for obesity and metabolic health. Combining more than 25 years of peptide R&D expertise with a proprietary data platform that leverages advanced data driven and AI/ML approaches, Zealand Pharma aims to lead a new era in obesity and metabolic health.

To date, more than 10 Zealand Pharma invented drug candidates have entered clinical development, of which two products have reached the market and three candidates are in late-stage development. The Company has collaborations with global pharmaceutical and biotechnology partners for research, development, and commercialization.

Founded in 1998, Zealand Pharma is headquartered in Copenhagen, Denmark, with a U.S. presence in Boston, Massachusetts. Learn more at www.zealandpharma.com.

Forward-looking statements
This press release contains “forward-looking statements”, as that term is defined in the Private Securities Litigation Reform Act of 1995 in the United States, as amended, even though no longer listed in the United States this is used as a definition to provide Zealand Pharma’s expectations or forecasts of future events regarding the research, development and commercialization of pharmaceutical products, the timing of the company’s pre-clinical and clinical trials and the reporting of data therefrom and the company’s significant events and potential catalysts in 2026 and financial guidance for 2026. These forward-looking statements may be identified by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would” and other words and terms of similar meaning. You should not place undue reliance on these statements, or the scientific data presented. The reader is cautioned not to rely on these forward-looking statements. Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions, which may cause actual results to differ materially from expectations set forth herein and may cause any or all of such forward-looking statements to be incorrect, and which include, but are not limited to, unexpected costs or delays in clinical trials and other development activities due to adverse safety events, patient recruitment or otherwise; unexpected concerns that may arise from additional data, analysis or results obtained during clinical trials; our ability to successfully market both new and existing products; changes in reimbursement rules and governmental laws and related interpretation thereof; government-mandated or market-driven price decreases for our products; introduction of competing products; production problems at third party manufacturers; dependency on third parties, for instance contract research or development organizations; unexpected growth in costs and expenses; our ability to affect the strategic reorganization of our businesses in the manner planned; failure to protect and enforce our data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; regulatory authorities may require additional information or further studies, or may reject, fail to approve or may delay approval of our drug candidates or expansion of product labeling; failure to obtain regulatory approvals in other jurisdictions; exposure to product liability and other claims; interest rate and currency exchange rate fluctuations; unexpected contract breaches or terminations; inflationary pressures on the global economy; and political and geopolitical uncertainty. If any or all of such forward-looking statements prove to be incorrect, our actual results could differ materially and adversely from those anticipated or implied by such statements. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. All such forward-looking statements speak only as of the date of this company announcement and are based on information available to Zealand Pharma as of the date of this announcement. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Information concerning pharmaceuticals (including compounds under development) contained within this material is not intended as advertising or medical advice.

Contacts
Eric Rojas (Investors)
Vice President, Head of Investor Relations
Zealand Pharma
Email: erojas@zealandpharma.com

Adam Lange (Investors)
Vice President, Investor Relations
Zealand Pharma
Email: alange@zealandpharma.com

Neshat Ahmadi (Investors)
Investor Relations Manager
Zealand Pharma
Email: neahmadi@zealandpharma.com

Rachel James-Owens (Media)
Vice President, Corporate Communications and Media Relations
Zealand Pharma
Email: rjamesowens@zealandpharma.com

Andreas Hylleberg Mølleskov (Media) 
Director, External Communications
Zealand Pharma
Email: ahylleberg@zealandpharma.com

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