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RENEW 2

Active not recruitingPhase 3

Weight Loss in People Living With Overweight or Obesity and Type 2 Diabetes Following Treatment With Cagrilintide

Efficacy and Safety of Cagrilintide for Weight Management in Participants With Overweight or Obesity and Type 2 Diabetes

Lead sponsor

Novo Nordisk A/S

Asset

CagriSema / cagrilintide

Subcutaneous · GLP-1 / amylin

Listed sites

Recruiting sites

—

Enrollment

330

estimated

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criterion

•BMI ≥27

Primary endpoints

•Body weight, % change•≥5% weight-loss responders

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07220759

Org study IDNN9833-8243

Secondary ID2024-519531-41European Medical Agency (EMA)

Secondary IDU1111-1314-9328World Health Organization (WHO)

Timeline

Milestones

Study first posted2025-10-24actual

Study start2025-11-05actual

Last update posted2026-04-21actual

Primary completion2027-05-12estimated

Study completion2027-06-30estimated

Assets

Investigational agents

CagriSema / cagrilintide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Eligibility criteria

Key Inclusion Criteria:

•Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.

•Female or male (sex at birth).

•Age 18 years or above at the time of signing the informed consent.

•History of at least one self-reported unsuccessful dietary effort to lose body weight.(a*)

•Body mass index (BMI) >= 27.0 kilogram per square meter (kg/m^2).(a*)

•Diagnosed with type 2 diabetes >= 180 days before screening.

•Treatment with either lifestyle intervention(a*), or:

–Stable treatment (same drug(s), dose and dosing frequency) for at least 90 days before screening with 1-3 marketed oral antidiabetic drugs (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose cotransporter 2 inhibitor (SGLT2i), thiazolidinediones, Dipeptidyl peptidase-4 inhibitor (DPP-4i) or sulphonylureas (SU) as a single agent or in combination according to local practice.(a*)

–For up to 30% of participants the following concomitant medication is allowed:

–Treatment for any indication with a stable dose of glucagon-like peptide-1 (GLP-1) containing medication, stable for at least 1 year before screening (a*) and/or

–Treatment with basal insulin minimum (0.25 units per kilogram per day (U/kg/day) or 20 units per day [U/day]) stable for at least 90 days before screening.(a*)

Key Exclusion Criteria:

•Treatment, or intention to initiate treatment, with any medication prescribed for the indication of weight management within 180 days before screening.(a*)

•Treatment with glucagon-like peptide-1 (GLP-1) receptor agonist (RA) or GLP-1 containing medication within 180 days before screening, apart from those randomized according to inclusion criteria 7bi.(a*)

•Previous dosing of marketed or non-marketed amylin-based compounds.(a*) (a*) - As declared by the participant, reported in the medical records or at the investigator's discretion.

Endpoints (30)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Cardiometabolic biomarkers

Weight & body composition

Glycemic / diabetes

Patient-reported / QoL

Safety / tolerability / PK

Weight & body composition

6 endpoints

Primary/protocol endpoint

Relative change in body weight

Time frame:From baseline (week 0) to end of treatment (week 64)

Body weight, % change

percent change from baseline, improvement

Primary/protocol endpoint

Number of participants with achievement of greater than or equals (>=) 5% body weight reduction

Time frame:From baseline (week 0) to end of treatment (week 64)

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Number of participants with achievement of >= 10% body weight reduction

Time frame:From baseline (week 0) to end of treatment (week 64)

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Number of participants with achievement of >= 15% body weight reduction

Time frame:From baseline (week 0) to end of treatment (week 64)

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change in waist circumference

Time frame:From baseline (week 0) to end of treatment (week 64)

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change in body weight

Time frame:From baseline (week 0) to end of treatment (week 64)

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

5 endpoints

Secondary/protocol endpoint

Change in glycated haemoglobin (HbA1c) in percentage-points (%-points)

Time frame:From baseline (week 0) to end of treatment (week 64)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in HbA1c in millimole per mole (mmol/mol)

Time frame:From baseline (week 0) to end of treatment (week 64)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in fasting plasma glucose (FPG) in millimole per liter (mmol/L)

Time frame:From baseline (week 0) to end of treatment (week 64)

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in FPG in milligram per deciliter (mg/dL)

Time frame:From baseline (week 0) to end of treatment (week 64)

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint/low confidence

Ratio to baseline in fasting serum insulin

Time frame:From baseline (week 0) to end of treatment (week 64)

ratio, improvement

Cardiometabolic biomarkers

10 endpoints

Secondary/protocol endpoint

Ratio to baseline in lipids: triglycerides

Time frame:From baseline (week 0) to end of treatment (week 64)

Triglycerides, change

ratio, improvement

LOINC 2571-8

Secondary/protocol endpoint

Ratio to baseline in high sensitivity C-reactive protein (hsCRP)

Time frame:From baseline (week 0) to end of treatment (week 64)

hs-CRP, change

ratio, improvement

LOINC 30522-7

Secondary/protocol endpoint

Change in systolic blood pressure (SBP)

Time frame:From baseline (week 0) to end of treatment (week 64)

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change in diastolic blood pressure (DBP)

Time frame:From baseline (week 0) to end of treatment (week 64)

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Ratio to baseline in lipids: total cholesterol

Time frame:From baseline (week 0) to end of treatment (week 64)

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Secondary/protocol endpoint

Ratio to baseline in lipids: high-density lipoprotein (HDL) cholesterol

Time frame:From baseline (week 0) to end of treatment (week 64)

HDL-C, change

ratio, improvement

LOINC 2085-9

Secondary/protocol endpoint

Ratio to baseline in lipids: low-density lipoprotein (LDL) cholesterol

Time frame:From baseline (week 0) to end of treatment (week 64)

LDL-C, change

ratio, improvement

LOINC 13457-7

Secondary/protocol endpoint

Ratio to baseline in lipids: very low-density lipoprotein (VLDL) cholesterol

Time frame:From baseline (week 0) to end of treatment (week 64)

VLDL, change

ratio, improvement

Secondary/protocol endpoint

Ratio to baseline in lipids: non-HDL cholesterol

Time frame:From baseline (week 0) to end of treatment (week 64)

Non-HDL cholesterol, change

ratio, improvement

Secondary/protocol endpoint

Ratio to baseline in lipids: free fatty acids

Time frame:From baseline (week 0) to end of treatment (week 64)

Free fatty acids, change

ratio, improvement

Patient-reported / QoL

5 endpoints

Secondary/protocol endpoint

Change in impact of weight on quality of life-lite clinical trials version (IWQOL-Lite-CT) physical function score

Time frame:From baseline (week 0) to end of treatment (week 64)

IWQOL-Lite physical

change from baseline, improvement

Secondary/protocol endpoint

Change in SF-36v2® health survey acute (SF-36v2® acute) physical component summary score

Time frame:From baseline (week 0) to end of treatment (week 64)

SF-36 physical

change from baseline, improvement

Secondary/protocol endpoint

Change in SF-36v2® mental component summary score

Time frame:From baseline (week 0) to end of treatment (week 64)

SF-36 mental

change from baseline, improvement

Secondary/protocol endpoint

Change in IWQOL-Lite-CT total score

Time frame:From baseline (week 0) to end of treatment (week 64)

IWQOL-Lite total

change from baseline, improvement

Secondary/protocol endpoint

Number of participants with achievement of at least 14.6-point increase in IWQOL-Lite-CT physical function score (yes/no)

Time frame:From baseline (week 0) to end of treatment (week 64)

IWQOL-Lite physical

threshold achievement, improvement

Safety / tolerability / PK

4 endpoints

Secondary/protocol endpoint

Number of treatment emergent adverse events

Time frame:From baseline (week 0) to end of study (week 71)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of treatment emergent serious adverse events (TESAEs)

Time frame:From baseline (week 0) to end of study (week 71)

Serious AEs (any)

event count, event

Secondary/protocol endpoint

Number of clinically significant hypoglycaemic episodes (level 2):<3.0 mmol/L [54 mg/dL], confirmed by blood glucose meter

Time frame:From baseline (week 0) to end of study (week 71)

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold

Time frame:From baseline (week 0) to end of study (week 71)

Severe hypoglycemia

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.