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Phase 1

CagrilintideA Study on How NNC0174-1213 Works in People With Overweight or Obesity.

Sponsor:

Novo Nordisk A/S

Code:

NCT06719011

Conditions

Obesity

Overweight

Eligibility Criteria

Sex: Male

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

NNC0174-1213 A

Cagrilintide B

Placebo A (NNC0174 1213 A)

Study Details

Brief summary:

This study is testing a new study medicine to treat people living with overweight or obesity. The aim of this study is to see if the medicine is safe, how it works in human body, and what human body does to the study medicine. Participants will either get the new study medicine NNC0174-1213, a study medicine called "cagrilintide" or a placebo (a "dummy medicine" similar to the new study medicine and study medicine but without active ingredients). Which treatment participants will get is decided by chance. The new study medicine and the study medicine are potential new medicines which cannot be prescribed by doctors. This study will last for about a year in total.

Conditions

Obesity

Overweight

Study ID

NCT06719011

Start date

Dec 3, 2024

Status verified date

Aug, 2026

Completion date

Jul 20, 2026

Primary completion date

Jul 20, 2026

Eligibility Criteria

Sex: Male

Age: 18 - 55

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

178 participants

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part A: NNC0174-1213 (SD1-SD5)

Part A: Single ascending dose (SAD) of NNC0174-1213 will be administered in cohorts 1-5.

experimental: Part A: Cagrilintide (SDA and SDB)

Part A: Single ascending dose (SAD): Cagrilintide SDA will be administered in cohort 1 and 2.

Cagrilintide SDB will be administered in cohort 3 and 4.

experimental: Part A: Placebo

Part A: Single ascending dose (SAD) of placebo will be administered to cohorts 1-5.

experimental: Part B: NNC0174-1213 (MD1-MD5)

Part B: Multiple ascending doses (MAD) of NNC0174-1213 will be administered to cohorts 1-5.

experimental: Part B: Cagrilintide (MDA)

Part B: Multiple ascending doses (MAD) of Cagrilintide MDA will be administered to cohorts 1-5.

experimental: Part B: Placebo

Part B: Multiple ascending doses (MAD) of placebo will be administered to cohorts 1-5.

Interventions

NNC0174-1213 A

Participants will be randomized to receive NNC0174-1213 A administered as subcutaneous (s.c. under the skin) injection.

Single ascending dose (SAD) will be injected for Part A cohorts and multiple ascending doses (MAD) will be injected for Part B cohorts.

Cagrilintide B

Participants will be randomized to receive Cagrilintide B administered as subcutaneous (s.c. under the skin) injection.

Single ascending dose (SAD) will be injected for Part A cohorts and multiple ascending doses (MAD) will be injected for Part B cohorts.

Placebo A (NNC0174 1213 A)

Participants will be randomized to receive Placebo administered as subcutaneous (s.c. under the skin) injection.

Single ascending dose (SAD) will be injected for Part A cohorts and multiple ascending doses (MAD) will be injected for Part B cohorts.

Primary outcome measure

Part A: Number of treatment emergent adverse events (TEAE) reported by participants exposed to NNC0174 1213 [ Time Frame: From NNC0174 1213 administration (Day 1) to completion of the end of study visit (Day 46) ]
Part B: Number of treatment emergent adverse events (TEAE) [ Time Frame: From first administration (Day 1) to completion of the end of study visit (Day 67) ]

Central Contacts and Locations

More Information

Sponsor

Novo Nordisk A/S

Last update posted

Aug 25, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by Novo Nordisk A/S on 2026-08-25. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.