Survodutide

also known as BI 456906 · Survodutida

Protein / enzyme biologic targets GCGR, GLP1R via activation

Developed for: obesity disorder · metabolic dysfunction-associated steatohepatitis · type 2 diabetes mellitus · chronic kidney disease · fibrotic liver disease
Investigated by: Boehringer Ingelheim · University Medical Center Groningen

Trials 36

today NCT07855900 · Ph 3 NCT07850050 · Ph 3 NCT07850063 · Ph 3 NCT07768813 · Ph 1 NCT07754461 · Ph 3 NCT07407348 · Ph 1 NCT07413913 · Ph 1 NCT07206290 · Ph 2 NCT07221591 · Ph 1 NCT07071974 · Ph 1 NCT06745284 · Ph 1 NCT06772532 · Ph 1 NCT06632457 · Ph 3 NCT05202353 · Ph 1 NCT06632444 · Ph 3 NCT06564441 · Ph 1 NCT06492135 · Ph 1 NCT06352411 · Ph 1 NCT06352424 · Ph 1 NCT06309992 · Ph 3 NCT06200467 · Ph 1 NCT06214741 · Ph 3 NCT06176365 · Ph 3 NCT05896384 · Ph 1 NCT06066528 · Ph 3 NCT06066515 · Ph 3 NCT06077864 · Ph 3 NCT05751226 · Ph 1 NCT05421338 · Ph 1 NCT05296733 · Ph 1 NCT04771273 · Ph 2 NCT04667377 · Ph 2 NCT04384081 · Ph 1 NCT04153929 · Ph 2 NCT03591718 · Ph 1 NCT03175211 · Ph 1

201820192020202120222023202420252026202720282029203020312032

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 120 trials
Phase 1	NCT07768813	Sep → Dec 2026 expected	obesity disorder	Boehringer Ingelheim	Recruiting	No outcome recorded
Phase 1	NCT07407348	Mar 2026 → Jan 2027 expected	obesity disorder	Boehringer Ingelheim	Active not recruiting	No outcome recorded
Phase 1	NCT07413913	Mar → May 2026	obesity disorder	Boehringer Ingelheim	Completed	No outcome recorded
Phase 1	NCT07221591	Nov 2025 → Aug 2026 overdue	—	Boehringer Ingelheim	Active not recruiting	No outcome recorded
Phase 1	NCT07071974	Jul → Oct 2025	—	Boehringer Ingelheim	Completed	No outcome recorded
Phase 1	NCT06745284	Mar 2025 → Jan 2027 expected	obesity disorder	Boehringer Ingelheim	Active not recruiting	No outcome recorded
Phase 1	NCT06772532	Feb → May 2025	—	Boehringer Ingelheim	Completed	No outcome recorded
Phase 1	NCT05202353	Nov 2024 → Jan 2027 expected	obesity disorder	Boehringer Ingelheim	Active not recruiting	No outcome recorded
Phase 1	NCT06564441	Oct 2024 → Dec 2025	obesity disorder	Boehringer Ingelheim	Completed	No outcome recorded
Phase 1	NCT06492135	Aug 2024 → Apr 2025	obesity disorder	Boehringer Ingelheim	Completed	No outcome recorded
Phase 1	NCT06352411	May 2024 → Sep 2025	impaired renal function disease	Boehringer Ingelheim	Completed	No outcome recorded
Phase 1	NCT06352424	Apr 2024 → Feb 2025	obesity disorder	Boehringer Ingelheim	Completed	No outcome recorded
Phase 1	NCT06200467	Mar 2024 → Oct 2025	obesity disorder	Boehringer Ingelheim	Completed	No outcome recorded
Phase 1	NCT05896384	Dec 2023 → Feb 2025	—	Boehringer Ingelheim	Completed	No outcome recorded
Phase 1	NCT05751226	Apr 2023 → Aug 2024	obesity disorder	Boehringer Ingelheim	Completed	No outcome recorded
Phase 1	NCT05421338	Jul → Nov 2022	—	Boehringer Ingelheim	Completed	No outcome recorded
Phase 1	NCT05296733	Apr 2022 → Dec 2023	liver disorder, obesity disorder	Boehringer Ingelheim	Completed	No outcome recorded
Phase 1	NCT04384081	Jun → Nov 2020	—	Boehringer Ingelheim	Completed	No outcome recorded
Phase 1	NCT03591718	Jul 2018 → Apr 2020	obesity disorder	Boehringer Ingelheim	Completed	No outcome recorded
Phase 1	NCT03175211	Jun 2017 → Feb 2018	—	Boehringer Ingelheim	Completed	No outcome recorded

Phase 24 trials · 3 met primary
Phase 2	NCT07206290	Mar 2026 → Nov 2027 expected	chronic kidney disease	University Medical Center Groningen	Not yet recruiting	No outcome recorded
Phase 2	NCT04771273	Apr 2021 → Nov 2023	metabolic dysfunction-associated steatohepatitis	Boehringer Ingelheim	Completed	Met primary
Phase 2	NCT04667377	Mar 2021 → Sep 2022	obesity disorder	Boehringer Ingelheim	Completed	Met primary
Phase 2	NCT04153929	Apr 2020 → Oct 2021	type 2 diabetes mellitus	Boehringer Ingelheim	Completed	Met primary
Phase 312 trials · 2 met primary
Phase 3	NCT07855900	Nov 2026 → Jun 2028 expected	obesity disorder	Boehringer Ingelheim	Not yet recruiting	No outcome recorded
Phase 3	NCT07850050	Oct 2026 → Jul 2028 expected	obesity disorder	Boehringer Ingelheim	Not yet recruiting	No outcome recorded
Phase 3	NCT07850063	Oct 2026 → Apr 2029 expected	metabolic dysfunction-associated steatotic liver disease, obesity disorder	Boehringer Ingelheim	Not yet recruiting	No outcome recorded
Phase 3	NCT07754461	Aug 2026 → Jan 2028 expected	type 2 diabetes mellitus	Boehringer Ingelheim	Recruiting	No outcome recorded
Phase 3	NCT06632457	Nov 2024 → Jun 2029 expected	metabolic dysfunction-associated steatohepatitis	Boehringer Ingelheim	Recruiting	No outcome recorded
Phase 3	NCT06632444	Oct 2024 → Dec 2031 expected	fibrotic liver disease, metabolic dysfunction-associated steatohepatitis	Boehringer Ingelheim	Recruiting	No outcome recorded
Phase 3	NCT06309992	Apr 2024 → Oct 2025	metabolic dysfunction-associated steatohepatitis, obesity disorder	Boehringer Ingelheim	Completed	No outcome recorded
Phase 3	NCT06214741	Feb 2024 → Jul 2025	obesity disorder	Boehringer Ingelheim	Completed	No outcome recorded
Phase 3	NCT06176365	Jan 2024 → Dec 2025	obesity disorder	Boehringer Ingelheim	Completed	No outcome recorded
Phase 3	NCT06066528	Nov 2023 → Dec 2025	obesity disorder, type 2 diabetes mellitus	Boehringer Ingelheim	Completed	Met primary
Phase 3	NCT06066515	Nov 2023 → Dec 2025	obesity disorder	Boehringer Ingelheim	Completed	Met primary
Phase 3	NCT06077864	Nov 2023 → Jun 2026	obesity disorder	Boehringer Ingelheim	Completed	No outcome recorded

News releases announcing trial results or a regulatory action · 11

Date	Issuer	Release
2026-10-01	Zealand Pharma	Results Zealand Pharma announces Boehringer Ingelheim’s survodutide achieves up to 13.1% weight loss in new Phase III trial, alongside significant improvements in glycemic control in people with obesity and type 2 diabetes zealandpharma.com ↗ Zealand Pharma announces Boehringer Ingelheim’s survodutide achieves up to 13.1% weight loss in new Phase III trial, alongside significant improvements in glycemic control in people with obesity and type 2 diabetes
2026-06-07	Zealand Pharma	Results Zealand Pharma announces Boehringer Ingelheim's survodutide Phase III trial in people living with obesity showed targeted 34% visceral and 63% liver fat reduction, while minimizing lean mass loss in pre-specified analysis zealandpharma.com ↗
2026-04-28	Zealand Pharma	Results 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 zealandpharma.com ↗ 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.
2024-10-08	Zealand Pharma	Regulatory Zealand Pharma announces that Boehringer receives U.S. FDA Breakthrough Therapy designation and initiates two Phase III trials in MASH for survodutide zealandpharma.com ↗
2024-06-07	Zealand Pharma	Results Zealand Pharma announces that Boehringer Ingelheim’s survodutide demonstrates breakthrough improvement in liver fibrosis with no worsening of MASH in 64.5% of patients with F2 and F3 fibrosis zealandpharma.com ↗ Additional sub-analysis shows up to 64.5% of adults with fibrosis stages F2 and F3 (moderate to advanced scarring) achieved an improvement in fibrosis without worsening of MASH.
2024-06-06	Zealand Pharma	Results Zealand Pharma announces that Boehringer Ingelheim will present positive results from Phase 2 trial with survodutide in MASH at EASL zealandpharma.com ↗ Zealand Pharma announces that Boehringer Ingelheim will present positive results from Phase 2 trial with survodutide in MASH at EASL
2024-02-26	Zealand Pharma	Results Zealand Pharma announces Boehringer Ingelheim survodutide Phase 2 trial shows 83% of adults treated achieved groundbreaking results in liver disease due to MASH, with significant improvements in fibrosis zealandpharma.com ↗ The trial met its primary endpoint with survodutide reaching a biopsy-proven improvement in MASH after 48 weeks, without worsening of fibrosis stages F1, F2 and F3 (mild to moderate or advanced scarring).
2023-06-23	Zealand Pharma	Results Data shows nearly 19% weight loss in people with overweight or obesity in Boehringer Ingelheim and Zealand Pharma Phase II trial with survodutide (BI 456906) zealandpharma.com ↗ People who completed the study on the 4.8 mg dose (actual treatment analysis) achieved nearly 19% weight loss.
2023-05-10	Zealand Pharma	Results Boehringer Ingelheim and Zealand Pharma announce phase II trial showed 14.9% weight loss in people living with obesity or overweight zealandpharma.com ↗ Boehringer Ingelheim and Zealand Pharma A/S (Nasdaq: ZEAL) today announced that patients treated with BI 456906 achieved up to 14.9% weight loss after 46 weeks, using the planned maintenance dose.
2022-11-01	Zealand Pharma	Results Zealand Pharma Announces Presentations at The Obesity Society Annual Meeting zealandpharma.com ↗ In the trial, bodyweight reductions of up to 9% were observed after treatment with BI 456906 for 16 weeks compared to 5.4% observed following open-label treatment with the GLP-1 receptor agonist semaglutide.
2022-09-21	Zealand Pharma	Results Zealand Pharma Announces Oral Presentation of Phase 2 Data for BI 456906 at the 58th Annual Meeting of the European Association for the Study of Diabetes (EASD) zealandpharma.com ↗ BI 456906 effectively lowered HbA1c up to -1.88% at week 16 in patients with type 2 diabetes in the Phase 2 clinical trial

All press releases naming this drug 12 releases

Date	Issuer	Release
2026-10-01	Zealand Pharma	Zealand Pharma announces Boehringer Ingelheim’s survodutide achieves up to 13.1% weight loss in new Phase III trial, alongside significant improvements in glycemic control in people with obesity and type 2 diabetes zealandpharma.com ↗
2026-06-07	Zealand Pharma	Zealand Pharma announces Boehringer Ingelheim's survodutide Phase III trial in people living with obesity showed targeted 34% visceral and 63% liver fat reduction, while minimizing lean mass loss in pre-specified analysis zealandpharma.com ↗
2026-04-28	Zealand Pharma	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 zealandpharma.com ↗
2024-10-08	Zealand Pharma	Zealand Pharma announces that Boehringer receives U.S. FDA Breakthrough Therapy designation and initiates two Phase III trials in MASH for survodutide zealandpharma.com ↗
2024-06-07	Zealand Pharma	Zealand Pharma announces that Boehringer Ingelheim’s survodutide demonstrates breakthrough improvement in liver fibrosis with no worsening of MASH in 64.5% of patients with F2 and F3 fibrosis zealandpharma.com ↗
2024-06-06	Zealand Pharma	Zealand Pharma announces that Boehringer Ingelheim will present positive results from Phase 2 trial with survodutide in MASH at EASL zealandpharma.com ↗
2024-02-26	Zealand Pharma	Zealand Pharma announces Boehringer Ingelheim survodutide Phase 2 trial shows 83% of adults treated achieved groundbreaking results in liver disease due to MASH, with significant improvements in fibrosis zealandpharma.com ↗
2023-10-05	Zealand Pharma	Phase III studies to investigate survodutide for people living with obesity and overweight, with and without diabetes, cardiovascular disease and chronic kidney disease zealandpharma.com ↗
2023-06-23	Zealand Pharma	Data shows nearly 19% weight loss in people with overweight or obesity in Boehringer Ingelheim and Zealand Pharma Phase II trial with survodutide (BI 456906) zealandpharma.com ↗
2023-05-10	Zealand Pharma	Boehringer Ingelheim and Zealand Pharma announce phase II trial showed 14.9% weight loss in people living with obesity or overweight zealandpharma.com ↗
2022-11-01	Zealand Pharma	Zealand Pharma Announces Presentations at The Obesity Society Annual Meeting zealandpharma.com ↗
2022-09-21	Zealand Pharma	Zealand Pharma Announces Oral Presentation of Phase 2 Data for BI 456906 at the 58th Annual Meeting of the European Association for the Study of Diabetes (EASD) zealandpharma.com ↗

Evidence & citations 8 cited values

Every value below carries the sentence it was read from. 38 sources stand behind the page.

Field	Value	Cited text
Known as	survodutide	“The purpose of this study is to find out whether a medicine called survodutide (BI 456906) has an effect on cardiac safety.” NCT06200467 ↗ 22 “the subcutaneous glucagon receptor/glucagon-like peptide-1 receptor dual agonist survodutide (BI 456906)” PMID 38095657 ↗ Dec 2023 “Formulation A of survodutide” NCT07407348 ↗ NCT07221591 ↗ NCT06066528 ↗ NCT06492135 ↗ NCT06745284 ↗ NCT06214741 ↗ NCT07206290 ↗ NCT06077864 ↗ NCT06066515 ↗ Show 12 more sources
Known as	BI 456906	“Bioequivalence of Two Survodutide (BI 456906) Formulations Via Subcutaneous Administration After Multiple Doses (an Open-label, Randomised, Multiple-dose, Crossover Trial)” NCT07407348 ↗ 16 “the subcutaneous glucagon receptor/glucagon-like peptide-1 receptor dual agonist survodutide (BI 456906)” PMID 38095657 ↗ Dec 2023 “Survodutide (BI 456906)” NCT07206290 ↗ NCT06200467 ↗ NCT05896384 ↗ NCT06352411 ↗ NCT05202353 ↗ NCT04384081 ↗ NCT05421338 ↗ NCT04667377 ↗ NCT03175211 ↗ Show 6 more sources
Known as	Survodutida	ChEMBL registry synonym — accepted as the source's own label CHEMBL5314776 ↗
Action	Activate	“novel subcutaneous glucagon-like peptide-1 receptor/glucagon receptor (GLP-1R/GCGR) dual agonist BI 456906” PMID 36527386 ↗ Jan 2023 1 “Glucagon-like peptide 1 receptor agonist” CHEMBL5314776 ↗
Modality	Protein / enzyme biologic	— CHEMBL5314776 ↗
Route	Subcutaneous	“novel subcutaneous glucagon-like peptide-1 receptor/glucagon receptor (GLP-1R/GCGR) dual agonist BI 456906” PMID 36527386 ↗ Jan 2023
Target	GCGR	“BI 456906 reduced plasma amino acids and glucagon, indicating target engagement at GCGRs and GLP-1Rs.” PMID 36527386 ↗ Jan 2023
Target	GLP1R	“Glucagon-like peptide 1 receptor agonist” CHEMBL5314776 ↗