Recruiting PHASE1 Obesity

Compares treatment options for Obesity

Official title A Study to See How Metabolism is Influenced by Weight Loss Due to Intervention With Cagrilintide and Semaglutide Compared to Diet

ClinicalTrials.gov ID: NCT07184086

What this study is testing

What is CagriSema (Cagrilintide B + semaglutide I)?

CagriSema (Cagrilintide B + semaglutide I) is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for obesity.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
In this study we will be looking into how CagriSema influences metabolism (the process by which food is used to supply energy for the body) compared to a diet. CagriSema is a new investigational medicine.
  • Phase 1: an early, usually small safety study

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 65

You may be able to join if

  • Male or female (sex assigned at birth).
  • Age 18-65 years (both inclusive) at the time of signing the informed consent.
  • Body Mass Index (BMI) greater than or equal to (≥) 30.0 kilograms per square meter (kg/m\^2) at screening (Visit 1). Excess body weight should be due...

You likely can't join if

  • Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive...
  • History of diabetes mellitus of any type, other than gestational diabetes mellitus.
  • Claustrophobia or severe discomfort of being confined in small rooms.
  • Contraindication for magnetic resonance imaging (MRI) scanning as per local guidance, including physical limitations that prevent the MRI scan.
  • Unusual meal habits (including, but not limited to, eating disorders) and special diet requirements or unwillingness to eat the food provided in the...
  • Treatment with metformin or other glucose-lowering agent(s) within 90 days before screening (V1), regardless of indication.
See the full eligibility criteria
Who can join
  • Male or female (sex assigned at birth).
  • Age 18-65 years (both inclusive) at the time of signing the informed consent.
  • Body Mass Index (BMI) greater than or equal to (≥) 30.0 kilograms per square meter (kg/m\^2) at screening (Visit 1). Excess body weight should be due to excess adipose tissue, as judged by the investigator.
What rules you out
  • Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method.
  • History of diabetes mellitus of any type, other than gestational diabetes mellitus.
  • Claustrophobia or severe discomfort of being confined in small rooms.
  • Contraindication for magnetic resonance imaging (MRI) scanning as per local guidance, including physical limitations that prevent the MRI scan.
  • Unusual meal habits (including, but not limited to, eating disorders) and special diet requirements or unwillingness to eat the food provided in the study.
  • Treatment with metformin or other glucose-lowering agent(s) within 90 days before screening (V1), regardless of indication.
  • Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening (Visit 1).
  • Presence or history of malignant neoplasms or in situ carcinomas (other than basal or squamous cell skin cancer, low-risk prostate cancer, or in situ carcinomas of the cervix or carcinoma in situ/high grade prostatic...
  • Physical measurement exceeding the dimensions or load capacity of the magnetic resonance imaging (MRI)/dual-energy X-ray absorptiometry (DEXA) scanner.

The study team makes the final eligibility decision.

Where it's taking place

  • Orlando, Florida, United States
  • Baton Rouge, Louisiana, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Orlando, Florida, United States; Baton Rouge, Louisiana, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.