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

A Randomized, Placebo Controlled and Double-blinded Study Assessing the Safety, Tolerability, Pharmacokinetics, and Efficacy of Subcutaneous Administrations of NNC0174 1213 in Male Participants With Overweight or Obesity.

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight
• Intervention / Treatment: Drug: NNC0174-1213 A; Drug: Cagrilintide B; Drug: Placebo A (NNC0174 1213 A)

• Study Type: Interventional
• Enrollment (Actual): 178
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78232
      • ICON Early Phase Services, LLC
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • ICON Early Phase Services, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A: NNC0174-1213 (SD1-SD5); Part A: Single ascending dose (SAD) of NNC0174-1213 will be administered in cohorts 1-5.	Drug: 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.; Drug: 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.; Drug: 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.
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.	Drug: 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.; Drug: 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.; Drug: 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.
Experimental: Part A: Placebo; Part A: Single ascending dose (SAD) of placebo will be administered to cohorts 1-5.	Drug: 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.; Drug: 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.; Drug: 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.
Experimental: Part B: NNC0174-1213 (MD1-MD5); Part B: Multiple ascending doses (MAD) of NNC0174-1213 will be administered to cohorts 1-5.	Drug: 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.; Drug: 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.; Drug: 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.
Experimental: Part B: Placebo; Part B: Multiple ascending doses (MAD) of placebo will be administered to cohorts 1-5.	Drug: 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.; Drug: 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.; Drug: 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.
Experimental: Part B: Cagrilintide (MDA); Part B: Multiple ascending doses (MAD) of Cagrilintide MDA will be administered to cohorts 1-5.	Drug: 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.; Drug: 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.; Drug: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part A: AUC; area under the NNC0174 1213 plasma concentration-time curve	measured in hour*nanomoles per liter (h*nmol/L).	From pre-dose on Day 1 to completion of the end of study visit (Day 46)
Part A: Cmax; maximum observed NNC0174 1213 plasma concentration	measured in nanomoles per liter (nmol/L).	From pre-dose on Day 1 to completion of the end of study visit (Day 46)
Part B: AUC; area under the NNC0174 1213 plasma concentration-time curve	measured in h*nmol/L.	From first administration (Day 1) to completion of the end of study visit (Day 67)
Part B: Cmax; maximum observed NNC0174 1213 plasma concentration	measured in nmol/L.	From first administration (Day 1) to completion of the end of study visit (Day 67)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2024
• Primary Completion (Actual): July 20, 2026
• Study Completion (Actual): July 20, 2026

Study Registration Dates

• First Submitted: December 2, 2024
• First Submitted That Met QC Criteria: December 2, 2024
• First Posted (Actual): December 5, 2024

Study Record Updates

• Last Update Posted (Actual): August 25, 2026
• Last Update Submitted That Met QC Criteria: August 21, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity
• Other Study ID Numbers: NN9839-8082; U1111-1308-5620 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No