Recruiting NCT07639021
A Research Study Comparing Different Ways of Increasing the Dose of NNC0662-0419 in Participants With Obesity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NNC0662-0419, Semaglutide, NNC0662-0419 Placebo, Semaglutide placebo.
- Who it may be relevant to
- Registry conditions: Obesity. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Puerto Rico
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluation of Different Dose Escalation Regimens for NNC0662-0419 in Participants With Obesity
Overview
The purpose of the study is to find out if NNC0662-0419 is safe and effective for treating participants living with obesity.
Interventions
- Drug NNC0662-0419
NNC0662-0419 will be administered subcutaneously. - Drug Semaglutide
Semaglutide will be administered subcutaneously. - Drug NNC0662-0419 Placebo
Placebo matched to NNC0662-0419 will be administered subcutaneously. - Drug Semaglutide placebo
Placebo matched to semaglutide will be administered subcutaneously.
Primary outcome measures
- Number of gastrointestinal adverse events [Time frame: From week 0 to week 39]
Secondary outcome measures (2)
- Relative change in body weight [Time frame: From week 0 to week 32]
- Change in body mass index (BMI) [Time frame: From week 0 to week 32]
Eligibility criteria
Inclusion criteria
- Male or female (sex assigned at birth, inclusive of all gender identities).
- Age 18 years or above at the time of signing the informed consent.
- Body mass index (BMI) greater than or equal to (≥) 30.0 kilogram per square meter (kg/m\^2) at screening.
- Participant must have a desire and be committed to lose at least 25 percentage (%) of their body weight from randomisation.
Exclusion criteria
- Known or suspected hypersensitivity to study intervention(s) or related products.
- Treatment with any medication prescribed for the indication of obesity or weight management (e.g. glucagon-like-peptide-1 (GLP-1) receptor agonists (RA), dual GLP-1/gastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment) or amylin analogues)) within 90 days before screening.
- Glycated haemoglobin (HbA1c) ≥ 6.5% (48 Millimoles per mole \[mmol/mol\]) as measured by the central laboratory at screening.
- History of type 1 or type 2 diabetes mellitus.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 24 centers
- Chambliss Clinical Trials, LLC — Montgomery
- FDRC — Costa Mesa
- Los Angeles Institute for Metabolic Research — Los Angeles
- Encore Medical Research LLC — Hollywood
- South Broward Research LLC — Miramar
- West Orange Endocrinology — Ocoee
- Cedar-Crosse Research Center — Chicago
- Great Lakes Clinical Trials — Chicago
- … and 16 more centers
Puerto Rico · 1 center
- Isis Clinical Res. Ctr P.S.C. — Guaynabo
Identifiers
NCT: NCT07639021 · NN9662-8649 · U1111-1333-3475