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

NCT ID: NCT06719011

Last Updated: 2025-05-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 177 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-03
• Study Completion Date: 2026-05-17

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Part A: NNC0174-1213 (SD1-SD5)

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

Group Type: EXPERIMENTAL

NNC0174-1213 A

Intervention Type: DRUG

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

Intervention Type: DRUG

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)

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

NNC0174-1213 A

Intervention Type: DRUG

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

Intervention Type: DRUG

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)

Intervention Type: DRUG

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.

Part A: Placebo

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

Group Type: EXPERIMENTAL

NNC0174-1213 A

Intervention Type: DRUG

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

Intervention Type: DRUG

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)

Intervention Type: DRUG

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.

Part B: NNC0174-1213 (MD1-MD5)

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

Group Type: EXPERIMENTAL

NNC0174-1213 A

Intervention Type: DRUG

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

Intervention Type: DRUG

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)

Intervention Type: DRUG

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.

Part B: Cagrilintide (MDA)

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

Group Type: EXPERIMENTAL

NNC0174-1213 A

Intervention Type: DRUG

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

Intervention Type: DRUG

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)

Intervention Type: DRUG

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.

Part B: Placebo

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

Group Type: EXPERIMENTAL

NNC0174-1213 A

Intervention Type: DRUG

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

Intervention Type: DRUG

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)

Intervention Type: DRUG

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.

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Transparency (dept. 2834)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

ICON Early Phase Services, LLC

San Antonio, Texas, United States

Site Status: RECRUITING

ICON Early Phase Services, LLC

Salt Lake City, Utah, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Novo Nordisk

Role: CONTACT

clinicaltrials@novonordisk.com

(+1) 866-867-7178

Other Identifiers

U1111-1308-5620

Identifier Type: OTHER

Identifier Source: secondary_id

NN9839-8082

Identifier Type: -

Identifier Source: org_study_id