Six selected reports include cagrilintide alone and the cagrilintide-semaglutide combination known as CagriSema. The later combination trials address different populations and questions from the earlier cagrilintide-alone study.↗↗↗↗↗↗
What the reviewed sources report
The selected cagrilintide-alone study reported weight reduction. Later combination trials reported weight or glycemic improvements, but their results cannot be attributed to cagrilintide alone. Gastrointestinal adverse events were common, and a correction to REIMAGINE 2 remains to be reconciled.↗↗↗↗↗↗
What remains unresolved?
Do larger and longer trials confirm durability, characterize uncommon harms, and show outcomes after treatment stops?↗
How do participant flow, missing outcomes, protocol history and linked corrections affect interpretation of the selected reports?↗↗↗↗↗↗
Reviews summarize selected studies; their scope and limitations are shown above.
Research coverage and study families
Search and screening record checked 2026-09-15. Counts describe records, not independent trials. Full-text appraisal is separate from an abstract review.
Catalog-name and calibrated alias discovery for human evidence review. Complete query retrieval is separate from clinical eligibility, study-family linkage and appraisal.
117 retrieved · 6 included · 5 excluded · 106 awaiting a decision · 0 full-text appraisals
Search terms, record decisions and remaining work
"Cagrilintide"[Title/Abstract] OR "AM833"[Title/Abstract]
Retrieved IDs completely represent this query response, not all relevant literature. Additional aliases, references and non-PubMed sources require separate searches.
Unscreened records may include animal or cell experiments, reviews, secondary analyses, mixtures, protocols and unrelated name matches.
Study-family mappings use available declared registry IDs; unresolved mappings do not create independent trial counts. Full-text, corrections and registry comparison remain separate work.
The selected newer trials are not a completed screen of this entire title/abstract search. Additional primary, secondary, safety and protocol reports remain to be appraised.
Showing 25 of 117 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
PubMed 42251860 — include: Selected primary trial report; the abstract and record metadata were read. Inclusion is not completed full-text appraisal. Study families: NCT06323174.
PubMed 42251859 — include: Selected primary trial report; the abstract and record metadata were read. Inclusion is not completed full-text appraisal. A linked publisher correction is recorded in the selected review; its interpretation requires the stated correction context. Study families: NCT06065540.
PubMed 42251856 — include: Selected primary trial report; the abstract and record metadata were read. Inclusion is not completed full-text appraisal. Study families: NCT06323161.
PubMed 40544433 — include: Selected primary trial report; the abstract and record metadata were read. Inclusion is not completed full-text appraisal. Study families: NCT05567796.
PubMed 40544432 — include: Selected primary trial report; the abstract and record metadata were read. Inclusion is not completed full-text appraisal. Study families: NCT05394519.
PubMed 34798060 — include: Selected published human report; abstract reviewed. Full-text and study-family appraisal remain separate. Study families: NCT03856047.Bibliographic record recheck · 2026-09-15
The selected PubMed XML payload matches the previous reviewed snapshot. This is a metadata recheck, not a new appraisal or a finding that no corrections exist. Open PubMed record ↗
PubMed 7829908 — exclude: The AM833 name also matches the antibiotic fleroxacin in these records; this is not cagrilintide human-administration evidence.
PubMed 1674242 — exclude: The AM833 name also matches the antibiotic fleroxacin in these records; this is not cagrilintide human-administration evidence.
PubMed 2110437 — exclude: The AM833 name also matches the antibiotic fleroxacin in these records; this is not cagrilintide human-administration evidence.
PubMed 3125788 — exclude: The AM833 name also matches the antibiotic fleroxacin in these records; this is not cagrilintide human-administration evidence.
PubMed 3094441 — exclude: The AM833 name also matches the antibiotic fleroxacin in these records; this is not cagrilintide human-administration evidence.
PubMed 42688617 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 42673585 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 42608559 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 42603595 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 42586227 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 42583410 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 42503495 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 42498824 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 42456707 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 42452898 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 42419792 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 42366647 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 42296503 — not screened: Name-query match awaiting clinical eligibility screening.
PubMed 42260119 — not screened: Name-query match awaiting clinical eligibility screening.
FDA search
Active-ingredient name query in openFDA Drugs@FDA. Returned application identities include salt forms and combination products; exact indications, approval conditions, supplements and marketing status require document-level review.
0 retrieved · 0 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals
Zero results describe this query response only, not absence of FDA approval or worldwide nonapproval.
This endpoint does not inventory every label, advisory proceeding, safety communication or regulatory document. Application inclusion does not establish current marketing or approval of every use.
Showing 0 of 0 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
EMA search
Local matching in the pinned EMA medicines feed; document matches also use identified EMA product numbers. This is not every national European record.
0 retrieved · 0 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals
Document appraisal and national European sources remain open.
Zero matches apply only to these feed fields and terms; orphan designation is not approval.
Showing 0 of 0 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
EMA search
Local matching in the pinned EMA documents feed; document matches also use identified EMA product numbers. This is not every national European record.
3 retrieved · 0 included · 0 excluded · 3 awaiting a decision · 0 full-text appraisals
Document appraisal and national European sources remain open.
Zero matches apply only to these feed fields and terms; orphan designation is not approval.
Showing 3 of 3 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
EMA 65092 — not screened: Title-name match awaiting identity and document review. P/0307/2023 : EMA decision of 4 August 2023 on the granting of a product specific waiver for cagrilintide / semaglutide (EMEA-003059-PIP02-23)
EMA 58934 — not screened: Title-name match awaiting identity and document review. P/241/2022 : EMA decision of 8 July 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for cagrilintide / semaglutide (EMEA-003059-PIP01-21)
EMA 74658 — not screened: Title-name match awaiting identity and document review. EMA/PE/0000240529 : EMA decision of 15 May 2025 on the acceptance of a modification of an agreed paediatric investigation plan for cagrilintide, semaglutide
EMA search
Local matching in the pinned EMA orphans feed; document matches also use identified EMA product numbers. This is not every national European record.
0 retrieved · 0 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals
Document appraisal and national European sources remain open.
Zero matches apply only to these feed fields and terms; orphan designation is not approval.
Showing 0 of 0 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
ClinicalTrials.gov search
ClinicalTrials.gov name/alias discovery, including cited product names. Matches may concern combinations, background references or different formulations; identity and outcomes need screening.
47 retrieved · 0 included · 0 excluded · 47 awaiting a decision · 0 full-text appraisals
Registration is not evidence that a study succeeded, that results were published, or that a use is approved.
Other registries, unregistered studies and additional aliases remain outside this query.
NCT06065540 lists enrollment of 2734, while PMID 42251859 reports 2713 randomized. The discrepancy and linked publisher correction remain unresolved.
NCT05567796 retains estimated enrollment of 3400 and active-not-recruiting status, while PMID 40544433 reports 3417 randomized participants. Registry history and extension context remain open.
NCT05394519 lists enrollment of 1200, while PMID 40544432 reports 1206 randomized. Participant-flow and registry-history reconciliation remains open.
Showing 25 of 47 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
ClinicalTrials.gov NCT06065540 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT06716307 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT05669755 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT07253285 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT07527195 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT07010432 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT06323174 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT06388187 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT05813925 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT05567796 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT07011667 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT07745504 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT06780449 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT06131437 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT07357766 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT07597018 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT05394519 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT06403761 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT05804162 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT04982575 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT06323161 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT06131372 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT07411560 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT06267092 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT06534411 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
Read the full Human Evidence Review
Supervised synthesis
What do selected human studies report about Cagrilintide?
Six selected reports include cagrilintide alone and the cagrilintide-semaglutide combination known as CagriSema. The later combination trials address different populations and questions from the earlier cagrilintide-alone study.123456
Bottom line from this bounded source set
The selected cagrilintide-alone study reported weight reduction. Later combination trials reported weight or glycemic improvements, but their results cannot be attributed to cagrilintide alone. Gastrointestinal adverse events were common, and a correction to REIMAGINE 2 remains to be reconciled.123456
Reviewed study record
Phase 2 weight-management trial
Design
A multicenter, randomized, double-blind, placebo-controlled and active-controlled dose-finding trial assessed body-weight change over 26 weeks.1
Population
The trial randomized 906 adults without diabetes across 57 sites in ten countries: 706 to cagrilintide groups, 99 to liraglutide, and 101 to placebo. Participants had obesity, or overweight with hypertension or dyslipidemia.1
Outcomes reported
Reported mean body-weight reduction ranged from 6.0% to 10.8% across cagrilintide groups and was 3.0% with placebo. Gastrointestinal events occurred more often across cagrilintide groups than with placebo.1
Limitations
This was a sponsor-funded, 26-week Phase 2 dose-finding study in adults without diabetes, with a short off-treatment follow-up and no long-term clinical-outcomes assessment.1
Reviewed study record
REDEFINE 1: combination treatment without diabetes
Design
A blinded randomized phase 3a trial compared combination treatment, either component alone and placebo over 68 weeks under NCT05567796.2
Population
The trial randomized 3,417 adults with overweight or obesity without diabetes across four groups.2
Outcomes reported
The treatment-policy analysis reported mean weight changes of −20.4% with cagrilintide-semaglutide versus −3.0% with placebo. Gastrointestinal adverse events occurred in 79.6% and 39.9%, respectively.2
Limitations
These estimates concern the combination and cannot be attributed to cagrilintide alone. The abstract does not give the component-alone outcome estimates needed to assess each component’s contribution.2
Reviewed study record
REDEFINE 2: combination treatment with diabetes
Design
A blinded randomized placebo-controlled phase 3a trial assessed weight endpoints at 68 weeks under NCT05394519.3
Population
The study randomized 1,206 adults with type 2 diabetes and overweight or obesity.3
Outcomes reported
The treatment-policy analysis reported mean weight changes of −13.7% with cagrilintide-semaglutide versus −3.4% with placebo. Gastrointestinal adverse events occurred in 72.5% and 34.4%, respectively.3
Limitations
This comparison evaluates the combination against placebo, not either component alone. Weight and glycemic outcomes do not establish prevention of long-term complications.3
Reviewed study record
REIMAGINE 1: early type 2 diabetes
Design
A blinded randomized placebo-controlled phase 3a trial assessed 40-week HbA1c change under NCT06323174.4
Population
The trial randomized 189 adults whose type 2 diabetes was inadequately controlled with diet and exercise.4
Outcomes reported
Under the efficacy analysis, HbA1c fell by 1.8 and 1.5 percentage points in the combination groups versus 0.1 with placebo. Adverse events occurred in 79%, 75% and 66%, respectively, and were predominantly mild or moderate gastrointestinal events.4
Limitations
The efficacy estimand differs from the treatment-policy analyses in the REDEFINE reports. These populations, endpoints and analyses should not be combined into a simple treatment ranking.4
Reviewed study record
REIMAGINE 2: comparison with component treatments
Design
A blinded randomized trial compared cagrilintide-semaglutide with component treatments and placebo over 68 weeks under NCT06065540.5
Population
The report concerns adults with type 2 diabetes receiving metformin with or without an SGLT2 inhibitor.5
Outcomes reported
The primary comparison concerns HbA1c change with the combination versus semaglutide. A publisher erratum is linked to this report; its impact on the numerical comparison has not been reconciled here.5
Limitations
The exact treatment difference is withheld pending review of the linked correction. This source should not be used here to infer the size of an additional benefit or to rank treatments.5
A blinded randomized placebo-controlled phase 3a trial assessed 40-week HbA1c change under NCT06323161.6
Population
The study randomized 274 adults with type 2 diabetes receiving basal insulin, with or without metformin.6
Outcomes reported
Under the efficacy analysis, HbA1c fell by 2.33 and 2.10 percentage points in the combination groups versus 0.66 with placebo. Gastrointestinal events were common; no severe hypoglycemia was reported.6
Limitations
The report recorded one death due to malignancy in an active group, considered unrelated to treatment. Absence of severe hypoglycemia in this study does not establish absence of risk, and the findings are not an individualized treatment recommendation.6
No registered Crossref update in the reviewed snapshotChecked August 19, 2026 for DOI 10.1016/s0140-6736(21)01751-7. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1056/nejmoa2502081. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1056/nejmoa2502082. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1016/s2213-8587(26)00126-9. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
Publication update registered by CrossrefErratum ↗ · publisher metadata · June 19, 2026 and August 1, 2026. Crossref metadata identifies the notice but does not by itself explain what wording changed.
No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1016/s0140-6736(26)01022-6. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
Explore status sources, recent additions, and coverage gaps
Living status brief
What is the current status of Cagrilintide?
Investigational. ClinicalTrials.gov lists a Novo Nordisk pediatric study as recruiting, updated July 17, 2026.↗
The cited status sources were checked through July 22, 2026. This answer changes only through the profile’s visible version and correction history.
PeptideScanner currently has no selected regulatory records and safety records connected to this profile. That is a collection gap, not evidence that no such records exist.
PeptideScanner does not infer an answer where the cited records do not provide one. Open the source-linked records below to inspect their scope and limits.
This map describes PeptideScanner’s selected, source-linked collection. It is not an evidence grade and does not establish research quality, safety, effectiveness, or medical relevance.
Status at observationRecruiting 2Active, not recruiting 1Not yet recruiting 1
A phase value is unavailable here for 4 selected records; this is not counted as “no phase.”
A status value is unavailable here for 4 selected records; this is not counted as a trial status.
PubMed bibliography
Publication composition
0 of 6 selected PubMed records include attributed title, venue, publication date, and publication-type fields.
Bibliography fields unavailable here for 6 selected records; the records remain visible as metadata observations.
Regulatory and publication surfaces
What is structurally connected?
Drugs@FDA applications
0
FDA Federal Register documents
0
DailyMed SPL versions
0
Canonical profile
Published
Profile structured data
Published
Linked dated records
14
Application counts reflect exact reviewed ingredient connections; Federal Register counts reflect exact reviewed peptide-name matches; DailyMed counts reflect listed SPL versions with retained ZIP receipts. “Published” describes this page’s indexing surface, not the state of scientific evidence.
PeptideScanner retained ClinicalTrials.gov record NCT07411560 at 2026-07-30T16:20:49.304Z. Its registry update date was 2026-04-13, and PeptideScanner's reviewed identity mapping was cagrilintide.
PeptideScanner retained ClinicalTrials.gov record NCT07607587 at 2026-07-30T16:19:03.059Z. Its registry update date was 2026-06-25, and PeptideScanner's reviewed identity mapping was cagrilintide.
PeptideScanner retained ClinicalTrials.gov record NCT07220759 at 2026-08-13T05:52:27.019Z. Its registry update date was 2026-08-03, and PeptideScanner's reviewed identity mapping was cagrilintide.
Counts and links describe PeptideScanner’s selected records. They are not rankings and do not establish research quality, safety, effectiveness, or medical relevance.
These links are based only on overlapping years and evidence lanes in PeptideScanner’s selected records. They do not imply that the peptides are medically or scientifically similar.
These dates come from selected source records and PubMed metadata. They are not a complete or continuous timeline of research, safety, approval, or effectiveness.
Evidence summary
What the cited records say
ClinicalTrials.gov lists a Novo Nordisk pediatric study as recruiting, updated July 17, 2026.↗
This is a source summary, not a medical recommendation. Status may differ by jurisdiction and product.
PeptideScanner retained ClinicalTrials.gov record NCT07745504 at 2026-08-13T05:52:27.004Z. Its registry update date was 2026-08-04, and PeptideScanner's reviewed identity mapping was cagrilintide.↗
PeptideScanner retained ClinicalTrials.gov record NCT07220759 at 2026-08-13T05:52:27.019Z. Its registry update date was 2026-08-03, and PeptideScanner's reviewed identity mapping was cagrilintide.↗
PeptideScanner retained ClinicalTrials.gov record NCT07220642 at 2026-07-30T16:19:03.066Z. Its registry update date was 2026-06-30, and PeptideScanner's reviewed identity mapping was cagrilintide.↗
PeptideScanner retained ClinicalTrials.gov record NCT07607587 at 2026-07-30T16:19:03.059Z. Its registry update date was 2026-06-25, and PeptideScanner's reviewed identity mapping was cagrilintide.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 39868309 at 2026-07-30T16:14:10.807Z. PubMed recorded a metadata revision date of 2026-06-25 and an Entrez history date of 2025-01-27. PeptideScanner associated this retained record with the identity slug cagrilintide. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 42260118 at 2026-07-30T16:14:18.129Z. PubMed recorded a metadata revision date of 2026-06-25 and an Entrez history date of 2026-06-08. PeptideScanner associated this retained record with the identity slug cagrilintide. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained ClinicalTrials.gov record NCT07557953 at 2026-07-30T16:19:36.906Z. Its registry update date was 2026-05-15, and PeptideScanner's reviewed identity mapping was cagrilintide.↗
PeptideScanner retained ClinicalTrials.gov record NCT07411560 at 2026-07-30T16:20:49.304Z. Its registry update date was 2026-04-13, and PeptideScanner's reviewed identity mapping was cagrilintide.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 40847076 at 2026-07-30T16:31:19.891Z. PubMed recorded a metadata revision date of 2026-01-06 and an Entrez history date of 2025-08-22. PeptideScanner associated this retained record with the identity slug cagrilintide. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 40609154 at 2026-07-30T18:24:19.064Z. PubMed recorded a metadata revision date of 2025-08-26 and an Entrez history date of 2025-07-03. PeptideScanner associated this retained record with the identity slug cagrilintide. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 40204768 at 2026-07-30T18:29:52.187Z. PubMed recorded a metadata revision date of 2025-04-12 and an Entrez history date of 2025-04-09. PeptideScanner associated this retained record with the identity slug cagrilintide. These dates describe PubMed metadata history, not the article's original publication date.↗