Drug evidence profileInvestigational - not approved for marketing

Survodutide results: weight loss, liver fat, Phase 3, and approval status.

Also searched as BI 456906 · glucagon/GLP-1 dual agonist

Survodutide is Boehringer Ingelheim and Zealand Pharma’s investigational once-weekly glucagon/GLP-1 receptor dual agonist. Phase 3 results now span body weight and liver-related measures, but efficacy-estimand maxima, MRI substudy findings, and gastrointestinal discontinuations need to stay attached to their exact populations.

Current development stage

What did the survodutide Phase 3 obesity trial show?

SYNCHRONIZE-1 studied 76 weeks of once-weekly survodutide or placebo in adults with obesity or overweight without type 2 diabetes. The sponsor reported average weight loss of up to 16.6% under the efficacy estimand versus 3.2% with placebo. A prespecified MRI substudy also reported reductions in visceral and liver fat, while gastrointestinal adverse events led to discontinuation in 19.0% of survodutide participants versus 2.9% on placebo. All three pieces belong in a balanced reading of the result.

Live decision workspace

Compare Survodutide with Retatrutide, without losing the country context.

Put evidence status, ClinicalTrials.gov coverage, official United States records, and qualified US research prices in one view. Blank fields stay blank when the underlying dataset does not support a number.

AIdentity record
Survodutide

Investigational clinical program

No linked research price board
Destination fixedUnited StatesNorth America

Official product and seller records attached

BComparison record
Retatrutide

Investigational clinical program

No linked research price board
01 · Status02 · Trials03 · Country04 · Price
Current program snapshot

What can you conclude about Survodutide today?

These are dated program facts, not a cross-trial ranking, approval forecast, personal treatment recommendation, or proof that a same-name online product is the sponsor's medicine.

Drug classDual agonist

An investigational molecule designed to activate glucagon and GLP-1 receptors.

SYNCHRONIZE-1Up to 16.6% at 76 weeks

Average loss under the efficacy estimand versus 3.2% with placebo among adults without diabetes.

GI discontinuation19.0% vs 2.9%

Sponsor-reported discontinuation due to gastrointestinal events in survodutide versus placebo groups.

MASLD Phase 384.2% met threshold

At least 30% liver-fat reduction at week 48 versus 24.3% with placebo under the efficacy estimand.

Marketing and authorization statusInvestigational - not approved for marketing
Evidence checked July 20, 2026Open lead source
Program identity

Know which molecule the result belongs to.

Sponsor
Boehringer Ingelheim + Zealand Pharma
Mechanism
Glucagon + GLP-1 receptor dual agonist
Route being studied
Once-weekly subcutaneous injection
Current stage
Phase 3 program active and reporting
Featured trial anchors
NCT06066515 · NCT06066528 · NCT06077864 · NCT06309992
Evidence checked
July 20, 2026
Sourced weight-loss trial results

Survodutide weight-loss results, with the trial attached.

This visual shows one selected result, not every dose or endpoint in the program. The percentage remains attached to its duration, population, comparator, analysis method, and source.

Evidence checked July 21, 2026
Phase 3Weekly injection
NCT06066515
16.6%Active-arm mean
SYNCHRONIZE-176 weeks

Survodutide reported 16.6% mean reduction at 76 weeks under the efficacy estimand, upper reported result. The comparator recorded 3.2% mean reduction.

Survodutide reported mean16.6%
Comparator mean3.2% mean reduction
Alternate analysis13%

Bar lengths share a 0 to 30% visual scale. They describe this selected record and do not make separate trials head-to-head.

Population
Adults with obesity or overweight
Participants
726 Actual enrollment in the completed trial record
Dose
6 mg, upper reported result
Primary analysis
Efficacy estimand, upper reported result
Alternate analysis
Treatment-regimen estimand
Regulatory status
Investigational; not FDA approved
ClinicalTrials.gov program landscape

Survodutide clinical trials by status, phase, and location.

The current exact-intervention snapshot matches 31 unique NCT records. This chart describes registry coverage and current study fields. It does not compare efficacy, safety, approval probability, eligibility, or treatment access.

Snapshot 2026-07-24
31matched NCT records
3overall Recruiting
3registry results posted
774recruiting site observations
34countries with recruiting sites
Registry phase mix3 phase labels
Phase labels come from ClinicalTrials.gov. A larger phase count is not stronger evidence or a better program.
2026 pipeline guide

What comes after Retatrutide?

Compare Zenagamtide/Amycretin, MariTide, CagriSema, standalone cagrilintide, and survodutide by route, evidence maturity, trial result, and approval status without ranking unrelated studies as one race.

Open the upcoming weight-loss drugs guide →
Worldwide status map

Survodutide across 42 countries.

This profile establishes the program identity and its cited clinical or regulatory record. It does not turn a same-name seller listing into the sponsor’s asset or prove authorization, availability, or lawful supply in another destination.

Compare Survodutide by country →Compare Survodutide by US state →Browse the global peptide country dataset →
Country-specific status checks

Is Survodutide approved or available in your country?

Start with the United States FDA record, then check the destination that matters to you. Each country page separates drug identity, authorization, product records, seller claims, and supply rules. Directory checked July 20, 2026.

Evidence ledger

What the record shows - and what it doesn’t.

Trial percentages are kept beside the design details that make them interpretable. Unknowns stay visible instead of being filled with launch speculation.

Supported
01

SYNCHRONIZE-1 reported Phase 3 efficacy

In adults with obesity or overweight without type 2 diabetes, the 76-week trial reported up to 16.6% average loss under the efficacy estimand versus 3.2% with placebo. ClinicalTrials.gov lists 726 actual participants and a completed record, while the peer-reviewed article is linked from the registry.

02

Body-composition findings came from a substudy

A prespecified SYNCHRONIZE-1 MRI substudy reported up to 34.0% relative reduction in visceral fat and up to 63.1% relative liver-fat reduction from baseline. Those imaging findings came from participants with measurements at baseline and end of study while on treatment, not automatically from the entire randomized population.

03

The liver-focused Phase 3 trial met both endpoints

SYNCHRONIZE-MASLD randomized 216 adults in the United States and Spain. At week 48, 84.2% on survodutide versus 24.3% on placebo achieved at least a 30% reduction in MRI-assessed liver fat under the efficacy estimand. Mean weight change was 12.2% versus 1.0%. The treatment-regimen estimates were 68.5% versus 28.6% for the liver-fat threshold and 8.7% versus 1.4% for weight.

04

Gastrointestinal tolerability is material

The sponsor reported nausea, vomiting, diarrhea, and constipation as the more frequent events compared with placebo. Discontinuation due to gastrointestinal adverse events was 19.0% with survodutide versus 2.9% with placebo in SYNCHRONIZE-1, an important counterweight to efficacy-only summaries.

Not established
01

No marketing approval or final label

Survodutide remains investigational and is not approved for marketing by a regulatory authority. There is no final obesity or liver-disease label, commercial dose, launch date, retail price, pharmacy channel, or insurance policy to compare.

02

Regulatory timing is not established here

Completed Phase 3 trials, Fast Track designation, Breakthrough Therapy designation, and an active cardiovascular study do not themselves establish a submission date or approval outcome. Those milestones must be documented separately by the sponsor or regulator.

03

Cross-trial ranking remains invalid

A 16.6% efficacy-estimand maximum cannot be ranked fairly against another program’s result without accounting for population, duration, dose, estimand, adherence, rescue treatment, missing data, and comparator. No head-to-head superiority claim is supported by the sources here.

Direct answers

The questions behind the search.

Concise answers based on the dated sponsor and trial records below. This is educational reporting, not medical advice.

01

What is survodutide and how does it work?

Survodutide, formerly BI 456906, is an investigational long-acting molecule designed to activate glucagon and GLP-1 receptors. Boehringer Ingelheim is responsible for global development and commercialization under a license from Zealand Pharma. The once-weekly injection is being studied for obesity and overweight, cardiovascular risk, and metabolic liver disease. Its glucagon activity is part of the scientific rationale for liver and metabolic effects, but a mechanism cannot substitute for completed clinical outcomes or regulatory review.

02

What did the survodutide Phase 3 obesity trial show?

SYNCHRONIZE-1 studied 76 weeks of once-weekly survodutide or placebo in adults with obesity or overweight without type 2 diabetes. The sponsor reported average weight loss of up to 16.6% under the efficacy estimand versus 3.2% with placebo. A prespecified MRI substudy also reported reductions in visceral and liver fat, while gastrointestinal adverse events led to discontinuation in 19.0% of survodutide participants versus 2.9% on placebo. All three pieces belong in a balanced reading of the result.

03

Is survodutide approved, and is it the same as retatrutide?

Survodutide is not approved for marketing as of this evidence check. It is also not the same molecule as retatrutide: survodutide activates glucagon and GLP-1 receptors, while retatrutide is designed to activate GIP, GLP-1, and glucagon receptors. Their trials use different programs, populations, durations, doses, and analysis methods, so their headline percentages cannot serve as a direct comparison. Neither investigational name should be treated as proof that an online research product is authentic clinical material.

04

Did survodutide reduce liver fat by 63%?

Two different 63-related findings are easy to confuse. A SYNCHRONIZE-1 MRI substudy reported up to a 63.1% relative reduction in liver fat from baseline among measured participants who remained on treatment. In an earlier Phase 2 MASH trial, 63% of participants in the 2.4 mg group achieved at least a 30% reduction in liver fat; that was a proportion of participants, not a 63% average reduction. The newer Phase 3 SYNCHRONIZE-MASLD trial used the same 30% threshold and reported 84.2% versus 24.3% with placebo under the efficacy estimand.

Important boundaryApproval status is jurisdiction-specific.

Do not use an investigational name, trial dose, or online research listing as a substitute for approved care. This page does not recommend treatment, sourcing, or participation in a clinical trial.

Understand the product-category boundary →
Primary referencesSurvodutide development profileMechanism, route, partnership, Phase 3 program, designations, and investigational statusZealand Pharma · Record checked July 17, 2026SYNCHRONIZE-1 and MASLD Phase 3 results76-week weight result, imaging substudy, adverse-event discontinuations, and liver-focused outcomesZealand Pharma · June 7, 2026SYNCHRONIZE-1 Phase 3 study - NCT06066515Sponsor, 76-week design, actual enrollment, study dates, route, and completed statusClinicalTrials.gov · Record checked July 17, 2026SYNCHRONIZE-MASLD Phase 3 peer-reviewed results216-participant design, 30% liver-fat threshold, weight results, estimands, adverse events, and study limitationsNational Library of Medicine, PubMed · June 7, 2026Phase 2 survodutide trial in MASH and fibrosisMASH improvement, proportions achieving at least 30% liver-fat reduction, fibrosis findings, and adverse eventsNational Library of Medicine, PubMed · June 7, 2024SYNCHRONIZE cardiovascular study - NCT06077864Cardiovascular Phase 3 design, dose arms, enrollment, and active record statusClinicalTrials.gov · Record checked July 17, 2026Survodutide once weekly for adults with obesityPeer-reviewed SYNCHRONIZE-1 publication record and trial interpretationPubMed / New England Journal of Medicine · June 7, 2026