Clinical and regulatory evidence comparison

CagriSema
vs Survodutide.

Compare CagriSema and survodutide by amylin versus glucagon strategy, Phase 3 weight results, liver evidence, tolerability, and approval status.

Also searched as Survodutide vs CagriSema · GLP-1 glucagon vs GLP-1 amylin

Direct answer

What is the difference?

CagriSema and survodutide are different investigational once-weekly obesity drugs with no head-to-head trial. CagriSema combines cagrilintide and semaglutide to engage amylin and GLP-1 pathways and is under FDA review. Survodutide is a single glucagon and GLP-1 receptor dual agonist with Phase 3 obesity and liver-focused evidence. Both have reported Phase 3 weight results, but only CagriSema has a publicly documented US application under review at this evidence check. Neither is approved for marketing, and their separate trials cannot establish which program is better.

Decision cockpit

See the useful differences first.

Start with identity, current US status, trial coverage, and the evidence relationship. Then carry the exact pair into a country-aware workspace without losing either record.

Program ACurrent evidence status

CagriSema

Submitted to FDA - not yet approved

Route
Once-weekly subcutaneous injection
Registry
30 matched NCT records
Sponsor
Novo Nordisk
Open the full CagriSema record
Program BCurrent evidence status

Survodutide

Investigational - not approved for marketing

Route
Once-weekly subcutaneous injection
Registry
31 matched NCT records
Sponsor
Boehringer Ingelheim + Zealand Pharma
Open the full Survodutide record
Evidence relationship map

CagriSema vs Survodutide: how direct is the evidence?

Separate trial programs

No participant in the cited sources was randomized between CagriSema and Survodutide. Identity, mechanism, route, trial design, and regulatory status can be compared. Subtracting percentages from separate studies would create a treatment effect the evidence did not test.

Program A

CagriSema

Amylin analogue + GLP-1 receptor agonist

Route
Once-weekly subcutaneous injection
Stage
Phase 3 / US regulatory review
Status
Submitted to FDA - not yet approved
Open CagriSema evidence
Program B

Survodutide

Glucagon + GLP-1 receptor dual agonist

Route
Once-weekly subcutaneous injection
Stage
Phase 3 program active and reporting
Status
Investigational - not approved for marketing
Open Survodutide evidence
Current registry snapshotIdentity-linked trial coverage

The current exact-intervention dataset contains 268 unique NCT records across 13 tracked investigational programs. Counts describe registry coverage, not comparative evidence strength.

QuestionEvidence statusHow to use it
Identity and mechanismSupported

Compare the named molecules, active components, sponsors, and receptor strategies.

Route, schedule, and stageSupported

Compare the studied route, frequency, development phase, and exact program record.

Regulatory statusCountry-specific

Compare exact approvals, applications, and investigational status in the jurisdiction being checked.

Trial-result differenceNot directly comparable

Treat percentages as separate source records. Do not subtract them, divide them into weekly rates, or use the larger value to name a winner.

Comparative safetyNo comparative conclusion

Use only adverse-event evidence reported for the cited protocol. Separate studies cannot establish which program is safer.

Better for an individualNot established

No group result, receptor count, route, approval milestone, or chart position predicts the best choice for one person.

Country status checks

Check both programs in the same market.

Approval, trial activity, product registration, pharmacy rules, and seller authority are country specific. Open both records before treating a status from one market as valid in another.

Program ANovo Nordisk

CagriSema

Amylin analogue + GLP-1 receptor agonist

Route
Once-weekly subcutaneous injection
Stage
Phase 3 / US regulatory review
Status
Submitted to FDA - not yet approved
Featured trial anchors
NCT05567796 · NCT05669755 · NCT07011667
Open the full CagriSema evidence profile
Program BBoehringer Ingelheim + Zealand Pharma

Survodutide

Glucagon + GLP-1 receptor dual agonist

Route
Once-weekly subcutaneous injection
Stage
Phase 3 program active and reporting
Status
Investigational - not approved for marketing
Featured trial anchors
NCT06066515 · NCT06066528 · NCT06077864 · NCT06309992
Open the full Survodutide evidence profile
Side-by-side record

Compare the field, then read the limit.

The pair is strategically important because CagriSema emphasizes strong pivotal weight-management evidence and a near-term regulatory path, while survodutide adds a dedicated liver and body-composition research story. Those are different strengths, not proof that either program is the right choice for an individual. A useful comparison preserves receptor strategy, endpoint, estimand, population, discontinuation, and regulatory status.

CagriSema and Survodutide clinical program comparison
FieldCagriSemaSurvodutideHow to interpret it
MechanismAmylin analogue plus GLP-1 receptor agonist combinationGlucagon plus GLP-1 receptor dual agonistBoth include GLP-1 activity, but amylin and glucagon strategies create different programs rather than interchangeable versions.
Weight evidence anchor22.7% at week 68 under the REDEFINE 1 trial-product estimandUp to 16.6% at week 76 under the SYNCHRONIZE-1 efficacy estimandDifferent estimands, trials, populations, and escalation plans prevent a direct or individual-level ranking.
Liver evidenceNo dedicated liver outcome anchors the current profilePhase 3 MRI liver-fat thresholds and a separate MASH programA liver endpoint is clinically distinct from total weight change and should not be converted into an overall superiority claim.
Tolerability contextGastrointestinal events were common in REDEFINE 1GI-event discontinuation was 19.0% versus 2.9% with placebo in SYNCHRONIZE-1Trial-specific definitions and exposure matter, so one disclosed rate does not establish a safer program across studies.
Current US statusNew Drug Application submitted and under FDA reviewPhase 3 program active and reporting, with no approval recordedRegulatory maturity differs, but neither name currently establishes an approved product, pharmacy route, price, or supply.
Evidence boundary

Why the headline numbers do not name a winner.

REDEFINE 1 reported 22.7% mean loss with CagriSema at week 68 under the trial-product estimand and 20.4% under the treatment-policy estimand. SYNCHRONIZE-1 reported up to 16.6% with survodutide at week 76 under an efficacy estimand and 13.0% under a treatment-regimen estimand. The trials did not share randomization, molecules, doses, escalation, populations, placebo responses, or missing-data rules. Survodutide's liver findings also answer a separate endpoint and do not create a weight-loss advantage claim.

Three reading rules

Keep the comparison honest.

  1. 01

    Compare weight estimands only as cross-trial orientation and keep each value attached to its duration, population, protocol, and placebo response.

  2. 02

    Treat survodutide's liver results as liver-specific evidence rather than proof of better weight loss, safety, or suitability for every patient.

  3. 03

    Keep CagriSema's FDA submission separate from approval and treat both development names as unable to authenticate an online product or seller.

Important boundaryNo comparison creates worldwide approval or verified supply.

A country-specific approval, clinical trial, or matching name does not authenticate an online product or establish access elsewhere. This page contains no treatment recommendation, buying route, personal-use protocol, or affiliate link.

Open the safety and status guide →
Primary referencesNovo Nordisk files for FDA approval of CagriSemaNDA submission, submitted regimen, Phase 3 result, and adverse-event summaryNovo Nordisk · December 18, 2025CagriSema REDEFINE 4 and FDA review updateInvestigational status, REDEFINE 4 results, and the sponsor's anticipated late-2026 FDA decision windowNovo Nordisk · February 23, 2026CagriSema REIMAGINE 1-3 Phase 3 resultsType 2 diabetes Phase 3 populations, efficacy estimands, weight results, adverse-event context, and projected Q4 2026 FDA decision windowNovo Nordisk · June 7, 2026Innovation and therapeutic focus - Annual Report 2025Mechanism, REDEFINE 1 and 2 results, and filing statusNovo Nordisk · February 2026REDEFINE 1 Phase 3 study - NCT05567796Sponsor, design, phase, publications, and current record statusClinicalTrials.gov · Record checked July 17, 2026REDEFINE 1 direct randomized resultsCagriSema, semaglutide, cagrilintide, and placebo results under the trial-product and treatment-policy estimandsNovo Nordisk · December 20, 2024REDEFINE 1 peer-reviewed publicationPeer-reviewed randomized trial design, population, interventions, results, and safety recordNational Library of Medicine, PubMed · June 22, 2025Long-term weight maintenance study - NCT07011667Ongoing Phase 3 long-term maintenance programClinicalTrials.gov · Record checked July 17, 2026Survodutide 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