Can a new injection help tackle obesity?
NCT ID NCT06719011
First seen Aug 25, 2026 · Last updated Aug 26, 2026 · Updated 1 time
Summary
This trial is testing an experimental drug called NNC0174-1213, either alone or with another drug called cagrilintide, to see if it is safe and how the body processes it. The study involves men aged 18-55 with overweight or obesity (BMI 27-34.9). Participants will receive the drug or a placebo via under-the-skin injections, and the study will last about a year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- NNC0174-1213, an experimental drug, tested alone or in combination with cagrilintide, both given as under-the-skin injections
- What this could lead to
- If successful, this could lead to a new treatment option for overweight or obesity, potentially offering better weight management.
- What could go wrong
- This is an early-stage trial focused on safety and how the drug works in the body, so it may not lead to an approved treatment. Side effects are possible, and the drug's effectiveness is not yet proven.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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178 people
The number who actually took part.
- Started
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Dec 2024
- Finished
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Jul 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 55 years
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Male. * Age 18-55 years (both inclusive) at the time of signing the informed consent. * Body mass index (BMI) between 27.0 and 34.9 kilogram per meter square (kg/m\^2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator. * Body weight more than or equal to (\>=) 80.0 kilograms (kg) at screening. * Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator. Exclusion Criteria: * Known or suspected hypersensitivity to study intervention(s) or related products. * Exposure to an investigational medicinal product within 2 months or 5 half-lives of the investigational medicinal product (if known), whichever is longer, before screening. * Participants report prior receipt of an amylin and/or calcitonin receptor agonist within the last 6 months. * Impaired liver function defined as any of the below: * Aspartate aminotransferase (AST) more than or equal to (\>=) 2 times upper limit of normal at screening * Alanine aminotransferase (ALT) more than or equal to (\>=) 2 times upper limit of normal at screening * Bilirubin more than (\>) 1.5 times upper limit of normal at screening (except if known or proven Gilbert's syndrome) * Renal impairment with estimated Glomerular Filtration Rate (eGFR) less than (\<) 75 milliliters per minute per 1.73 square meter (mL/min/1.73 m\^2) at screening. * Glycated haemoglobin (HbA1c) more than or equal to (\>=) 6.5 percent (%) (48 millimoles per mole (mmol/mol) at screening. * Any clinically significant body weight change more than or equal to (\>=) 5 percent (%) self-reported change) or dieting attempts (e.g., participation in a weight reduction program) within 90 days before screening . * Any disorder, unwillingness or inability which in the investigator's opinion, might jeopardize the participant's safety or compliance with the protocol. * Any laboratory safety parameters at screening outside the below laboratory ranges, see designated reference range documents for specific values: * Vitamin D (25-hydroxycholecalciferol) less than (\<) 12 nanogram per milliliter (ng/mL) (30 nanometer (nM) at screening * Parathyroid hormone (PTH) outside normal range at screening * Total calcium outside normal range at screening * Calcitonin more than or equal to (\>=) 50 nanogram per liter (ng/L) at screening
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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ICON Early Phase Services, LLC
San Antonio, Texas, 78232, United States
-
ICON Early Phase Services, LLC
Salt Lake City, Utah, 84124, United States
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