Obesity & Overweight
tested AUC0-168h,cagri,2.4/2.4mg,SS area under the cagrilintide concentration-time curve during a dosing interval (0-168 hours) at steady state after last dosing of cagrilintide 2.4 mg in combination with semaglutide 2.4 mg
result Completed; results not posted
Diabetes Mellitus, Type 2
tested Change in Glycated Haemoglobin (HbA1c): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Semaglutide 2.4 mg + Placebo (Cagrilintide)
result −0.3 Percentage of HbA1c (Change in Glycated Haemoglobin (HbA1c): Cagrilinti…)
RCTNCT05394519Phase 3 · 2023 · n=1200 · Novo Nordisk A/S Overweight
tested Relative change in body weight
result Completed; results not posted
Pharmacokinetic / healthy volunteer studies
tested Part A: AUC 0-infinity (∞), single dose (SD), cagri: The area under the cagrilintide plasma concentration-time curve fromtime 0 to infinity after a single dose
result Completed; results not posted
RCTNCT05567796Phase 3 · 2022 · n=3400 · Novo Nordisk A/S Obesity
tested CagriSema versus placebo: Relative change in body weight
result In progress (active-not-recruiting)
RCTNCT05669755Phase 3 · 2023 · n=7101 · Novo Nordisk A/S Cardiovascular Disease
tested Time to first occurrence of 3-point major adverse cardiovascular event (MACE), a composite endpoint consisting of: cardiovascular (CV) death, non-fatal myocardial infarction, non-fatal stroke
result In progress (active-not-recruiting)
RCTNCT05804162Phase 1 · 2023 · n=107 · Novo Nordisk A/S Obesity
tested Change From Baseline in Fridericia Heart Rate Corrected QT Interval (QTcF) At 12, 24, 48 and 72 Hours Post-Second Dose of Cagrilintide/Cagrilintide Placebo at the 4.5 mg Dose Level
result Completed; results not posted
RCTNCT05813925Phase 3 · 2023 · n=331 · Novo Nordisk A/S Obesity or Overweight
tested Relative Change in Body Weight
result Completed; results not posted
RCTNCT05996848Phase 3 · 2023 · n=300 · Novo Nordisk A/S Obesity or Overweight
tested CagriSema 2.4 mg/2.4 mg versus placebo: Relative change in body weight
result Completed; results not posted
RCTNCT06065540Phase 3 · 2023 · n=2734 · Novo Nordisk A/S Type 2 Diabetes Mellitus
tested CagriSema (dose 1) versus semaglutide (dose 1): Change in glycated haemoglobin (HbA1c)
result Completed; results not posted
RCTNCT06131372Phase 2 · 2024 · n=626 · Novo Nordisk A/S Chronic Kidney Disease
tested Change in urinary albumin-to-creatinine ratio (UACR)
result Completed; results not posted
RCTNCT06131437Phase 3 · 2023 · n=809 · Novo Nordisk A/S Obesity
tested To confirm non-inferiority of CagriSema versus tirzepatide: Relative change in body weight
result Completed; results not posted
Obesity
tested Relative change in energy intake during ad libitum lunch, evening meal and snackbox
result Completed; results not posted
RCTNCT06221969Phase 3 · 2024 · n=1024 · Novo Nordisk A/S Type 2 Diabetes
tested Change in glycated haemoglobin (HbA1c)
result Completed; results not posted
RCTNCT06267092Phase 1 · 2024 · n=164 · Novo Nordisk A/S Overweight
tested Change in mean postprandial appetite score based on visual analogue scale (VAS)
result Completed; results not posted
Obesity
tested AUC0-72hours,atorv,SD: Area under the atorvastatin plasma concentration-time curve from time 0 to 72 hours after a single dose of atorvastatin without CagriSema exposure and at CagriSema steady state
result Completed; results not posted
RCTNCT06323161Phase 3 · 2024 · n=274 · Novo Nordisk A/S Type 2 Diabetes
tested Change in Glycated Haemoglobin (HbA1c)
result Completed; results not posted
RCTNCT06323174Phase 3 · 2024 · n=189 · Novo Nordisk A/S Type 2 Diabetes
tested Change in glycated haemoglobin (HbA1c)
result Completed; results not posted
RCTNCT06388187Phase 3 · 2024 · n=300 · Novo Nordisk A/S Obesity
tested Relative change in body weight
result Completed; results not posted
RCTNCT06403761Phase 1 · 2024 · n=158 · Novo Nordisk A/S Diabetes Mellitus, Type 2
tested To compare the effect of CagriSema versus placebo: Change in M-value in hyperinsulinaemic euglycaemic clamp (HEC)
result Completed; results not posted
RCTNCT06409130Phase 2 · 2024 · n=270 · Novo Nordisk A/S Alcohol-related Liver Disease
tested Change in Enhanced Liver Fibrosis (ELF)
result Completed; results not posted
RCTNCT06534411Phase 3 · 2024 · n=1023 · Novo Nordisk A/S Diabetes Mellitus, Type 2
tested Change in Glycated Haemoglobin (HbA1c)
result Completed; results not posted
Obesity
tested AUC0-∞,cagri,0.25 milligram (mg)/0.25mg,SD: Area under the cagrilintide concentration-time curve after a single dose 0.25 mg/0.25 mg CagriSema A in PDS290 pen-injector or CagriSema in DV3384 pen-injector
result Completed; results not posted
Small sample; effect at the edge of clinical significance.
RCTNCT06719011Phase 1 · 2024 · n=177 · Novo Nordisk A/S Obesity
tested Part A: Number of treatment emergent adverse events (TEAE) reported by participants exposed to NNC0174 1213
result In progress (recruiting)
RCTNCT06780449Phase 3 · 2025 · n=400 · Novo Nordisk A/S Obesity
tested Relative change in body weight
result In progress (active-not-recruiting)
RCTNCT06797869Phase 2 · 2025 · n=142 · Novo Nordisk A/S Diabetes Mellitus, Type 2
tested Change in weekly average Pain Intensity-Numerical Rating Scale (PI-NRS)
result In progress (active-not-recruiting)
RCTNCT07010432Phase 1 · 2025 · n=144 · Novo Nordisk A/S Obesity
tested Relative change in volumetric bone mineral density (vBMD) of the total hip assessed by quantitative computed tomography (QCT)
result In progress (recruiting)
RCTNCT07011667Phase 3 · 2025 · n=609 · Novo Nordisk A/S Obesity
tested Relative change in body weight
result In progress (active-not-recruiting)
Obesity
tested Change in sleeping metabolic rate (SMR)
result In progress (recruiting)
RCTNCT07220642Phase 3 · 2025 · n=300 · Novo Nordisk A/S Obesity
tested Relative change in body weight
result In progress (active-not-recruiting)
RCTNCT07220759Phase 3 · 2025 · n=330 · Novo Nordisk A/S Overweight
tested Relative change in body weight
result In progress (active-not-recruiting)
RCTNCT07253285Phase 3 · 2026 · n=460 · Novo Nordisk A/S Overweight
tested Relative change in body mass index (BMI)
result In progress (recruiting)
Diabetes Mellitus, Type 2
tested Change in glycated haemoglobin (HbA1c)
result In progress (recruiting)
RCTNCT07411560Phase 1 · 2026 · n=100 · Novo Nordisk A/S Overweight
tested Number of Treatment Emergent Adverse Events (TEAEs) nausea, vomiting and diarrhoea
result In progress (recruiting)
RCTNCT07527195Phase 1 · 2026 · n=100 · Novo Nordisk A/S Obesity
tested Change in insulin-stimulated fluorodeoxyglucose (FDG) uptake in skeletal muscle
result In progress (recruiting)
RCTNCT07557953Phase 1 · 2026 · n=120 · Novo Nordisk A/S Overweight
tested Relative change in total energy intake across ad libitum breakfast, lunch, evening meal and snack box
result In progress (recruiting)
RCTNCT07597018Phase 1 · 2026 · n=234 · Novo Nordisk A/S Obesity
tested AUC,ss: area under the total cagrilintide concentration-time curve at steady state after 5th dosing of cagrilintide s.c.
result In progress (recruiting)
Overweight
tested AUCss: area under the total cagrilintide concentration-time curve at steady state after 5th dosing of cagrilintide
result In progress (active-not-recruiting)
RCTNCT07607587Phase 1 · 2026 · n=114 · Novo Nordisk A/S Obesity
tested Percentage of participants on standard dose or higher dose (yes/no) of cagrilintide and placebo
result In progress (recruiting)
RCTNCT07745504Phase 3 · 2026 · n=285 · Novo Nordisk A/S Overweight
tested Relative change in body weight
result In progress (recruiting)
Treatment studies
tested Change in HbA1c from baseline at 32 weeks (primary); bodyweight, fasting plasma glucose, CGM parameters, safety
result HbA1c: CagriSema -2.2pp, semaglutide -1.8pp, cagrilintide -0.9pp. ETD CagriSema vs cagrilintide -1.3pp (95%CI -1.7 to -0.8). CagriSema had greater weight loss vs both.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Diagnostic & mechanistic studies
tested time-matched change from baseline in QTcF at 12, 24, 48, 72 h after last dose
result No clinically relevant QTcF prolongation; upper limits of 90% CIs for placebo-adjusted QTcF changes were below 10 ms at all 4 time points (n=53 cagrilintide, n=52 placebo).
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested Percent change in body weight at week 68; proportion achieving ≥5% weight reduction; glycemic measures; safety
result CagriSema: −13.7% body weight vs −3.4% placebo (diff −10.4 pp, P<0.001); HbA1c ≤6.5% in 73.5% vs 15.9%.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested Relative change in body weight and ≥5% body weight reduction at 68 weeks
result CagriSema: -20.4% body weight vs -3.0% placebo (diff -17.3 pp, 95% CI -18.1 to -16.6, P<0.001); ≥30% weight loss achieved by more CagriSema vs placebo participants.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested Change in systolic and diastolic blood pressure from baseline to week 68; proportion reaching BP targets
result CagriSema vs placebo at wk 68: SBP −10.9 vs −2.8 mmHg; DBP −5.4 vs −1.7 mmHg; BP targets reached 63.0% vs 32.0%; resistant-HTN subgroup 42.0% vs 29.3% (OR 1.7).
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested Relative change in bodyweight from baseline to week 68
result Cagrilintide-semaglutide: -18.4% vs semaglutide: -11.9% bodyweight change (ETD -6.5 pp, 95% CI -8.4 to -4.6; p<0.0001) at week 68.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested HbA1c change from baseline to week 40 (primary); bodyweight change; hypoglycaemia
result HbA1c −2.33% (2.4mg) and −2.10% (1.0mg) vs −0.66% placebo at wk 40; ETD −1.68 pp (p<0.0001); robust bodyweight reduction; no added hypoglycaemia risk.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested Change in HbA1c from baseline to week 68 (primary); bodyweight, safety
result CagriSema 2.4mg vs sema 2.4mg: HbA1c −1.91 vs −1.75 pp (ETD −0.16 pp [95% CI −0.27 to −0.05]; p=0.0035)
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested Change in HbA1c from baseline to week 40 (primary); bodyweight change (secondary)
result HbA1c change at 40 wks: −1.8pp (2.4 mg, n=62) and −1.5pp (1.0 mg, n=63) vs −0.1pp placebo; treatment diff −1.7pp (95% CI −2.0 to −1.3).
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Preclinical / mechanistic research
tested rodent · Preclinical Weight Loss Efficacy of AM833 in Combination With Semaglutide in Rodent Models of Obesity
result Preclinical publication captured from PubMed/Europe PMC; effect details require paper-level extraction.
Preclinical / mechanistic research
tested rat · CagriSema drives weight loss in rats by reducing energy intake and preserving energy expenditure.
result Preclinical publication captured from PubMed/Europe PMC; effect details require paper-level extraction.
Preclinical / mechanistic research
tested In vitro and in vivo antibacterial activity of AM-833, a new quinolone derivative.
result In-vitro publication captured from PubMed/Europe PMC; assay details require paper-level extraction.
Preclinical / mechanistic research
tested In vitro activity of Ro 23-6240, a new fluorinated 4-quinolone.
result In-vitro publication captured from PubMed/Europe PMC; assay details require paper-level extraction.
Preclinical / mechanistic research
tested In vitro metabolic profiling of weight-loss-inducing amylin receptor agonists in the context of preventive doping research.
result In-vitro publication captured from PubMed/Europe PMC; assay details require paper-level extraction.
Preclinical / mechanistic research
tested Mitochondrial Adaptations in Skeletal Muscle Following Incretin-Based Therapies: In Vitro.
result In-vitro publication captured from PubMed/Europe PMC; assay details require paper-level extraction.
Preclinical / mechanistic research
tested Cellular loci for cagrilintide action identified.
result In-vitro publication captured from PubMed/Europe PMC; assay details require paper-level extraction.