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Trial · Interventional

Active, not recruitingPhase 3Registry data

Weight Loss in People Living With Overweight or Obesity Following Treatment With Cagrilintide

Short name RENEW 1

NCTNCT07220642 (opens ClinicalTrials.gov in a new tab)Other idNN9833-8242Other idU1111-1314-8906Other id2024-519530-24
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Active, not recruiting
Phase
Phase 3
Enrollment
300 participants (estimated)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Quadruple masking
Countries
10 countries

United States, Argentina, Australia, Canada, France, Germany, Italy, Norway, Poland, United Kingdom

Start
5 Nov 2025
Primary completion
11 May 2027 (estimated)
Completion
29 Jun 2027 (estimated)
First posted
24 Oct 2025
Last update posted
6 Aug 2026
Conditions
Obesity · Overweight

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2025202620272028
  1. Ph 3

    RENEW 1

    NCT07220642

    5 Nov 2025 to est. 29 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 lower their body weight. Cagrilintide is a new investigational medicine. Doctors may not yet prescribe cagrilintide. Participants will either get cagrilintide or placebo. Which treatment participants 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. Possible side effects will be followed carefully during the study. For each participant, the study will last for about 1 year and 6 months.

Interventions

  • CagrilintideDrug
  • PlaceboDrug

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.

  1. Relative change in body weight

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

    Registry description

    Measured as percentage (%).

Secondary outcomes(20)

  1. Number of participants with achievement of greater than or equal to (>=) 10 percent (%) body weight reduction (yes/no)

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

    Registry description

    Measured as count of participants.

  2. 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.

  3. Change in waist circumference

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

    Registry description

    Measured as centimeters (cm).

  4. Ratio to baseline in triglycerides

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

    Registry description

    Measured as ratio.

  5. 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.

  6. 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.

  7. 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).

  8. Change in body weight

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

    Registry description

    Measured as kilograms (kg).

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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)

    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.

  14. Change in Diastolic Blood Pressure (DBP)

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

    Registry description

    Measured as mmHg.

  15. Ratio to baseline of total cholesterol

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

    Registry description

    Measured as ratio.

  16. Ratio to baseline of High-Density Lipoprotein (HDL) cholesterol

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

    Registry description

    Measured as ratio.

  17. Ratio to baseline of Low-Density Lipoprotein (LDL) cholesterol

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

    Registry description

    Measured as ratio.

  18. Ratio to baseline of Very Low-Density Lipoprotein (VLDL) cholesterol

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

    Registry description

    Measured as ratio.

  19. Ratio to baseline of non-HDL cholesterol

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

    Registry description

    Measured as ratio.

  20. Ratio to baseline of free fatty acids

    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
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) greater than or equal to \>= 30.0 kilogram per square meter (kg/m\^2), or BMI greater than or equal to \>= 27.0 kg/m\^2 with the presence of at least one weight related comorbidity including, but not limited to, hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease (a\*) Exclusion criteria: * History of type 1 or type 2 diabetes (a\*) * Treatment, or intention to initiate treatment, with any medication prescribed for the indication of weight management within 180 days before screening (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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