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Trial · Interventional

Active, not recruitingPhase 3Registry data

A Research Study to Look at How Well CagriSema Helps People Living With Obesity Lose Weight and Maintain Weight Loss in the Long-term

NCTNCT07011667 (opens ClinicalTrials.gov in a new tab)Other idNN9838-8484Other idU1111-1318-6372
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Active, not recruiting
Phase
Phase 3
Enrollment
609 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
3 Jun 2025
Primary completion
1 Mar 2027 (estimated)
Completion
17 Oct 2028 (estimated)
First posted
9 Jun 2025
Last update posted
30 Sept 2026
Conditions
Obesity

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20252026202720282029
  1. Ph 3

    A Research Study to Look at How Well CagriSema Helps People Living With Obesity Lose Weight and Maintain Weight Loss in the Long-term

    NCT07011667

    3 Jun 2025 to est. 17 Oct 2028

Registry summary

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

This study will look at how well CagriSema helps people living with obesity to lose weight and maintain the weight loss long-term. The study has 2 parts: The first part is called 'the main study' and the second part is called 'the extension study'. In the main study participants will either get CagriSema (a study medicine) or placebo (a dummy medicine that looks like CagriSema but has no active ingredient). Which treatment participants get is decided by chance. Participants are two times more likely to get CagriSema than placebo. If participants get CagriSema in the main study, participants will continue on CagriSema in the extension study. Which dose of CagriSema participants will continue on is decided by chance. If participants get placebo in the main study, participants will get CagriSema in the extension study. Participants will take one injection of study medicine once a week. The study will last for about 3 years and 3 months.

Interventions

  • CagriSema (Cagrilintide B and Semaglutide I)Drug
  • Placebo matched to CagriSema (Cagrilintide B and Semaglutide I)Drug

Arms2

  • Experimental

    CagriSema

    Participants will receive CagriSema subcutaneously once weekly in a dose escalation manner (dose increases every 4 weeks) for up to 16 weeks followed by CagriSema maintenance dose subcutaneously once weekly for 64 weeks in the main phase of the study. Participants randomised to this arm will be included in the extension phase to receive 1 of the 3 dose levels of CagriSema for 80 weeks.

  • Placebo comparator

    Placebo

    Participants will receive placebo matched to CagriSema subcutaneously once weekly for 80 weeks in the main phase of the study. Participants randomised to this arm will be included in the extension phase to receive CagriSema with flexible dose escalation for 80 weeks.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Relative change in body weight

    Time frame · From baseline (week 0) to week 80

    Registry description

    Measured as percentage change.

Secondary outcomes(20)

  1. Relative change in body weight in women

    Time frame · From baseline (week 0) to week 80

    Registry description

    Measured as percentage change.

  2. Number of participants who achieve greater than or equals (≥) 20% weight reduction

    Time frame · From baseline (week 0) to week 80

    Registry description

    Measured as count of participants.

  3. Number of participants who achieve ≥ 25% weight reduction

    Time frame · From baseline (week 0) to week 80

    Registry description

    Measured as count of participants.

  4. Number of participants who achieve ≥ 30% weight reduction

    Time frame · From baseline (week 0) to week 80

    Registry description

    Measured as count of participants.

  5. Number of participants who achieve BMI < 30 kg/m^2

    Time frame · From baseline (week 0) to week 80

    Registry description

    Measured as count of participants.

  6. Number of participants who achieve normal body mass index (BMI) (18.5 kilograms per meter square (kg/m^2) less than or equal to (≤ ) BMI < 25 kg/m^2)

    Time frame · From baseline (week 0) to week 80

    Registry description

    Measured as count of participants.

  7. Change in waist circumference

    Time frame · From baseline (week 0) to week 80

    Registry description

    Measured as centimeter (cm).

  8. Change in systolic blood pressure

    Time frame · From baseline (week 0) to week 80

    Registry description

    Measured as millimeters of mercury (mmHg).

  9. Ratio to baseline in C-reactive protein (CRP)

    Time frame · From baseline (week 0) to week 80

    Registry description

    Measured as ratio.

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

    Time frame · From baseline (week 0) to week 80

    Registry description

    Measured as ratio.

  11. Ratio to baseline in lipids: triglycerides

    Time frame · From baseline (week 0) to week 80

    Registry description

    Measured as ratio.

  12. Ratio to baseline in lipids: HDL

    Time frame · From baseline (week 0) to week 80

    Registry description

    Measured as ratio.

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

    Time frame · From baseline (week 0) to week 80

    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. Physical function score ranges from 0 to 100, with higher scores indicating better levels of functioning.

  14. Change in short form (SF)-36v2 physical function

    Time frame · From baseline (week 0) to week 80

    Registry description

    Measured as score on a scale. The 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, i.e. transformed to a scale where the 2009 United States general population has a mean of 50 and a standard deviation of 10. Physical functioning score ranges from 19.0-57.6, with higher scores indicating better functional health and well-being.

  15. Change in IWQOL-Lite-CT physical function for subgroup with poor physical functioning at baseline (according to patient global impression of status [PGI-S])

    Time frame · From baseline (week 0) to week 80

    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. Physical function score ranges from 0 to 100, with higher scores indicating better levels of functioning. PGI-S at baseline is used to define the subgroup with "poor" physical function in IWQOL-Lite-CT.

  16. Change in SF-36v2 physical function for subgroup with poor physical functioning at baseline (according to PGI-S)

    Time frame · From baseline (week 0) to week 80

    Registry description

    Measured as score on a scale. SF-36v2 acute measures 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, i.e. transformed to a scale where the 2009 United States general population has a mean of 50 and a standard deviation of 10. Physical functioning score ranges from 19.0-57.6, with higher scores indicating better functional health and well-being. PGI-S at baseline is used to define the subgroup with "poor" physical function in SF-36V2.

  17. Number of participants who achieve ≥ 5% weight reduction

    Time frame · From baseline (week 0) to week 80

    Registry description

    Measured as count of participants.

  18. Number of participants who achieve ≥ 10% weight reduction

    Time frame · From baseline (week 0) to week 80

    Registry description

    Measured as count of participants.

  19. Number of participants who achieve ≥ 15% weight reduction

    Time frame · From baseline (week 0) to week 80

    Registry description

    Measured as count of participants.

  20. Change in waist to height ratio

    Time frame · From baseline (week 0) to week 80

    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: * Male or female (sex at birth). * Age 18 years or above at the time of signing the informed consent. * BMI ≥ 30.0 kilogram per square meter (kg/m\^2) at screening. * Participant has a wish to lose at least 25% of body weight within 80 weeks from randomisation. key Exclusion Criteria: * Glycated haemoglobin (HbA1c) ≥ 6.5% (48 millimole per mole \[mmol/mol\]) as measured by the central laboratory at screening. * History of type 1 or type 2 diabetes.

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