Actively Recruiting

Phase 1
Age: 18Years - 64Years
All Genders
ID07557953

A Study Investigating the Effect of Cagrilintide on Energy Intake and Appetite in People With Overweight or Obesity

Led by Novo Nordisk A/S · Updated on 2026-05-15

120

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying how cagrilintide, a medicine given by injection, affects food intake and appetite in adults with overweight or obesity. The goal is to understand changes in energy intake and appetite over a treatment period. This is a phase 1 clinical trial sponsored by Novo Nordisk A/S, designed to gather early information about cagrilintide's effects compared to a placebo. Participants will be randomly assigned to one of two groups: one group will receive cagrilintide injections once a week for up to 17 weeks, and the other group will receive placebo injections that look like the medicine but contain no active drug. The treatment phase lasts about 17 weeks, and participants will be monitored throughout this time to assess the study medicine's impact. During the study, participants will have meals where their energy intake is measured at breakfast, lunch, dinner, and snack times. Appetite will be evaluated using questionnaires and scales that assess hunger, fullness, and cravings. Researchers will track changes from baseline to the end of treatment. The total study duration is about 30 weeks, including screening and follow-up, with safety and health monitoring occurring throughout.

CONDITIONS

Brief Title

A Research Study Looking Into How Cagrilintide Influences Food Intake and Appetite in People With Overweight or Obesity

Who Can Participate

Age: 18Years - 64Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female (sex at birth)
  • Age 18 to 64 years at the time of signing the informed consent
  • Body mass index (BMI) of 27.0 kg/m² or higher at screening
  • Generally healthy except for overweight or obesity as judged by medical history and tests
Not Eligible

You will not qualify if you...

  • Known or suspected allergy to the study medicine or related products
  • Pregnant, breastfeeding, intending to become pregnant, or of childbearing potential not using adequate birth control
  • History or presence of significant respiratory, metabolic, kidney, liver, heart, digestive, or hormone-related conditions
  • Glycated hemoglobin (HbA1c) of 6.5% or higher at screening
  • History of type 1 or type 2 diabetes
  • Significant weight change (5% or more) or dieting attempts within 90 days before screening
  • Use of incretin therapies within 6 months before screening or stopped due to side effects
  • Use of weight-lowering drugs or drugs that may cause weight gain (except short-term corticosteroids) within 6 months before screening
  • Previous use of amylin-based compounds

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 17 weeks

Participants receive weekly subcutaneous injections of either Cagrilintide or placebo for up to 17 weeks to study its effect on energy intake and appetite.

Weekly visits for up to 17 weeks

Trial Site Locations

Total: 1 location

1

Parexel International GmbH

Berlin, Germany, 14050

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Research Team

N

Novo Nordisk

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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