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

Short name RENEW 2

NCTNCT07220759Other idNN9833-8243Other idU1111-1314-9328Other id2024-519531-41

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Active, not recruiting
Phase: Phase 3
Enrollment: 330 participants (estimated)
Sponsor: Novo Nordisk A/S · Industry
Design: Randomized · Quadruple masking
Countries: 11 countries
United States, Argentina, Canada, Croatia, Czechia, Hungary, Romania, Slovakia, South Korea, Switzerland, United Kingdom
Start: 5 Nov 2025
Primary completion: 12 May 2027 (estimated)
Completion: 30 Jun 2027 (estimated)
First posted: 24 Oct 2025
Last update posted: 7 Oct 2026
Conditions: Overweight · Obesity · Type 2 Diabetes

Timeline

1 trial · 1 ongoing

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2025202620272028

Ph 3
RENEW 2
NCT07220759
5 Nov 2025 to est. 30 Jun 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This study will look at how much cagrilintide helps people with overweight or obesity and type 2 diabetes lower their body weight. Cagrilintide is a new investigational medicine. Doctors may not yet prescribe cagrilintide. Participant will either get cagrilintide or placebo. Which treatment participant get is decided by chance. Participants are two times more likely to get cagrilintide than placebo. Like all medicines, the study medicine may have side effects. For each participant, the study will last for about 1 year and 6 months.

Interventions

CagrilintideDrug
Placebo (matched to Cagrilintide)Drug

Arms2

Experimental
Cagrilintide
Participants will receive cagrilintide subcutaneously once weekly for 64 weeks.
Placebo comparator
Placebo
Participants will receive placebo matched to cagrilintide subcutaneously once weekly for 64 weeks.

Primary outcomes1

Outcomes the sponsor listed as primary.

Relative change in body weight
Time frame · From baseline (week 0) to end of treatment (week 64)
Registry description
Measured as percentage (%) of body weight.

Secondary outcomes(20)

Number of participants with achievement of >= 10% body weight reduction (yes/no)
Time frame · From baseline (week 0) to end of treatment (week 64)
Registry description
Measured as count of participants.
Number of participants with achievement of >= 15% body weight reduction (yes/no)
Time frame · From baseline (week 0) to end of treatment (week 64)
Registry description
Measured as count of participants.
Change in waist circumference
Time frame · From baseline (week 0) to end of treatment (week 64)
Registry description
Measured as centimeter (cm).
Ratio to baseline in lipids: triglycerides
Time frame · From baseline (week 0) to end of treatment (week 64)
Registry description
Measured as ratio.
Ratio to baseline in high sensitivity C-reactive protein (hsCRP)
Time frame · From baseline (week 0) to end of treatment (week 64)
Registry description
Measured as ratio.
Change in glycated haemoglobin (HbA1c)
Time frame · From baseline (week 0) to end of treatment (week 64)
Registry description
Measured as percentage of HbA1c.
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)
Registry description
Measured as score on a scale. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. The physical function score ranges from 0-100.
Change in systolic blood pressure (SBP)
Time frame · From baseline (week 0) to end of treatment (week 64)
Registry description
Measured as millimeter of mercury (mmHg).
Change in body weight
Time frame · From baseline (week 0) to end of treatment (week 64)
Registry description
Measured as kilogram (kg).
Number of participants with achievement of >= 5% body weight reduction (yes/no)
Time frame · From baseline (week 0) to end of treatment (week 64)
Registry description
Measured as count of participants.
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)
Registry description
Measured as score on a scale. SF-36v2 Acute measures Health-Related Quality of Life (HRQoL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 Acute scores are norm-based scores, that is. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Higher scores indicate better functional health and well-being. The physical component summary score ranges from 6.1 to 79.7.
Change in SF-36v2® mental component summary score
Time frame · From baseline (week 0) to end of treatment (week 64)
Registry description
Measured as score on a scale. SF-36v2 Acute measures Health-Related Quality of Life (HRQoL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 Acute scores are norm-based scores, that is. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Higher scores indicate better functional health and well-being. The mental component summary score ranges from -3.8 to 78.7.
Change in IWQOL-Lite-CT total score
Time frame · From baseline (week 0) to end of treatment (week 64)
Registry description
Measured as score on a scale. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. The total score ranges from 0-100.
Number of participants with achievement of at least 14.6-point increase (yes/no) in IWQOL-Lite-CT physical function score
Time frame · From baseline (week 0) to end of treatment (week 64)
Registry description
Measured as count of participants. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. The physical function score ranges from 0-100.
Change in diastolic blood pressure (DBP)
Time frame · From baseline (week 0) to end of treatment (week 64)
Registry description
Measured as mmHg.
Ratio to baseline in lipids: total cholesterol
Time frame · From baseline (week 0) to end of treatment (week 64)
Registry description
Measured as ratio.
Ratio to baseline in lipids: high-density lipoprotein (HDL) cholesterol
Time frame · From baseline (week 0) to end of treatment (week 64)
Registry description
Measured as ratio.
Ratio to baseline in lipids: low-density lipoprotein (LDL) cholesterol
Time frame · From baseline (week 0) to end of treatment (week 64)
Registry description
Measured as ratio.
Ratio to baseline in lipids: very low-density lipoprotein (VLDL) cholesterol
Time frame · From baseline (week 0) to end of treatment (week 64)
Registry description
Measured as ratio.
Ratio to baseline in lipids: non-HDL cholesterol
Time frame · From baseline (week 0) to end of treatment (week 64)
Registry description
Measured as ratio.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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). * Diagnosed with type 2 diabetes \>= 180 days before screening.(a\*) * 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.

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