NCT07607587

Brief Summary

The purpose of this clinical study is to look at the safety of the medicine Cagrilintide when compared to placebo in people who do not tolerate marketed glucagon-like peptide-1 (GLP-1) therapies and who live with overweight or obesity. Participants will get either Cagrilintide (the treatment being tested) or Placebo (a treatment that has no active medicine in it). Which treatment participant will get is decided by chance. The study will last for about 8 months.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P75+ for phase_1 obesity

Timeline
17mo left

Started May 2026

Typical duration for phase_1 obesity

Geographic Reach
1 country

11 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
May 2026Nov 2027

First Submitted

Initial submission to the registry

May 19, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 26, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

May 29, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 19, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 19, 2027

Last Updated

May 26, 2026

Status Verified

May 1, 2026

Enrollment Period

1.5 years

First QC Date

May 19, 2026

Last Update Submit

May 19, 2026

Conditions

ObesityOverweight

Outcome Measures

Primary Outcomes (1)

  • Percentage of participants on standard dose or higher dose (yes/no) of cagrilintide and placebo

    Measured as percentage of participants.

    At week 26

Study Arms (2)

Cagrilintide

EXPERIMENTAL

Participants will receive Cagrilintide for 26 weeks.

Drug: Cagrilintide

Placebo

PLACEBO COMPARATOR

Participants will receive placebo matched to Cagrilintide for 26 weeks.

Drug: Placebo (matched to Cagrilintide)

Interventions

CagrilintideDRUG

Cagrilintide will be administered subcutaneously.

Cagrilintide
Placebo (matched to Cagrilintide)DRUG

Placebo matched to Cagrilintide will be administered subcutaneously.

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female (sex at birth)
  • Age 18 years or above at the time of signing the informed consent
  • History of documented treatment with GLP-1-RA medications with gastrointestinal (GI) adverse effects as the main reason for treatment discontinuation
  • Not suitable for re-initiation of GLP-1-RA treatment based on medical history and investigator judgement
  • Body mass index (BMI) greater than or equal to (≥) 30.0 kilograms per square meter (kg/m\^2)

You may not qualify if:

  • Female who is pregnant, breast-feeding, or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive methods
  • Treatment with GLP-1 receptor agonist or GLP-1-RA medication for any indication within 8 weeks before screening
  • History of type 1 or type 2 diabetes
  • Glycated haemoglobin (HbA1c) ≥ 6.5 percent (%) (48 millimole per mole \[mmol/mol\]) as measured by the central laboratory at screening
  • Treatment with glucose-lowering agent(s) prescribed for the indication of diabetes or pre-diabetes within 90 days before screening
  • Treatment with any medication prescribed for the indication of weight management within 8 weeks before screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Diablo Clinical Research, Inc.

Walnut Creek, California, 94598, United States

Location

Northeast Research Institute

Fleming Island, Florida, 32003, United States

Location

Jacksonville Ctr For Clin Res

Jacksonville, Florida, 32216, United States

Location

Center for Diab,Obes & Metab

Pembroke Pines, Florida, 33024, United States

Location

Encore Medical Research of Weston

Weston, Florida, 33331, United States

Location

Monroe Biomedical Research, LLC

Monroe, North Carolina, 28112, United States

Location

Accellacare

Wilmington, North Carolina, 28401, United States

Location

Coastal Carolina Research Ctr

North Charleston, South Carolina, 29405, United States

Location

Holston Medical Group_Bristol

Bristol, Tennessee, 37620, United States

Location

Amarillo Medical Specialists

Amarillo, Texas, 79124, United States

Location

Elligo Clin Res Centre

Austin, Texas, 78704, United States

Location

MeSH Terms

Conditions

ObesityOverweight

Interventions

cagrilintide

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Clinical Transparency (dept. 2834)

    Novo Nordisk A/S

    STUDY DIRECTOR

Central Study Contacts

Novo Nordisk

CONTACT

(+1) 866-867-7178clinicaltrials@novonordisk.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2026

First Posted

May 26, 2026

Study Start

May 29, 2026

Primary Completion (Estimated)

November 19, 2027

Study Completion (Estimated)

November 19, 2027

Last Updated

May 26, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

More information

Locations

US(11)