A Research Study on How Well Different Doses of the Medicine NNC0662-0419 Help People Living With Overweight or Obesity

NCT07184632 | Active Not Recruiting Phase 2 FDA Drug

• 2 other identifiers: NN9662-8110U1111-1317-2736
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 2

Brief Summary

This study tests how well different doses of the medicine NNC0662-0419 help people living with overweight or obesity. The purpose of the study is to find out if NNC0662-0419 is safe and effective for treating people living with overweight or obesity. There are 2 study treatments in this study, participants will get either NNC0662-0419, the treatment being tested or placebo, a treatment that has no active medicine in it. NNC0662-0419 is a new medicine which cannot be pre-scribed by doctors but has previously been tested in humans.

Conditions

Overweight; Obesity

Outcome Measures

Primary Outcomes (3)

• Part A: Number of treatment-emergent adverse events (TEAE)

  Measured as number of events.

  From baseline (week 0) to end of study (up to week 44)

• Part B: Relative change in body weight

  Measured as percentage (%).

  From baseline (week 0) to end of treatment (week 36)

• Part C: Occurrence of premature treatment discontinuation (Yes/No)

  Measured as count of participants.

  At end of treatment (week 24)

Secondary Outcomes (12)

• Part A: Relative change in body weight

  From baseline (week 0) to end of treatment (up to week 40)

• Part A: Change in body weight

  From baseline (week 0) to end of treatment (up to week 40)

• Part A: AUC; the area under the NNC0662-0419 plasma concentration-time curve

  From pre-dose on day 1 to completion of the end of study visit (up to week 44)

• Part A: Cmax; the maximum plasma concentration of NNC0662-0419

  From pre-dose on day 1 to completion of the end of study visit (up to week 44)

• Part B: Change in body weight

  From baseline (week 0) to end of treatment (week 36)

Study Arms (2)

NNC0662-0419

EXPERIMENTAL

Participants will be randomized to receive NNC0662-0419 subcutaneously (s.c.). The study will be conducted in 3 parts. Part A: Multiple ascending dose (MAD), Part B: Dose range finding (DFR) and Part C (2-week escalation).

Drug: NNC0662-0419

Placebo

PLACEBO COMPARATOR

Participant will be randomized to receive placebo in: The study will be conducted in 3 parts. Part A: Multiple ascending dose (MAD), Part B: Dose range finding (DFR) and Part C (2-week escalation).

Drug: Placebo

Interventions

NNC0662-0419 DRUG

NNC0662-0419 will be administered subcutaneously.

NNC0662-0419

Placebo DRUG

Placebo matched to NNC0662-0419 will be administered subcutaneously.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female (sex at birth).
• Age at the time of signing the informed consent:
• For Part A:18-55 years (both inclusive)
• For Part B and Part C: 18-65 years (both inclusive)
• Body Mass Index (BMI) at screening (overweight should be due to excess adipose tissue, as judged by the investigator):
• For Part A: 27.0-39.9 kilogram per square meter(kg/m\^2) (both inclusive)
• For Part B and Part C:
• Greater than or equal to (≥) 27.0 kg/m\^2 with the presence of at least one weight-related comorbidity (e.g. hypertension, dyslipidaemia, obstructive sleep apnoea or CV disease), or
• Greater than or equal to (≥) 30.0 kg/m\^2
• 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.
• Willingness to obtain a high weight loss (greater than \[\>\] 25 percent \[%\]).

You may not qualify if:

• Known or suspected hypersensitivity to study intervention(s) or related products.
• Treatment with any compound containing Glucagon-Like Peptide 1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP) or amylin receptor agonism within 90 days before screening.
• Any condition, unwillingness or inability, which in the investigator's opinion might jeopardise the participant's safety or compliance with the protocol.
• nd or 3rd degree atrioventricular-block, prolongation of the QRS complex over 120 millisecond (ms), or of the corrected QT interval by Fridericia (QTcF) calculation over 450 ms (females) or 430 ms (males), or any other clinically significant abnormal ECG results as judged by the investigator, at screening.
• Glycosylated haemoglobin (HbA1c) greater than or equal to (≥) 6.5% (48 millimoles per mole \[mmol/mol\]) at screening.
• History of type 1 or type 2 diabetes mellitus.
• Calcitonin greater than or equal to (≥) 50 nanogram per litre (ng/L) at screening.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (2)

Celerion, Phoenix

Tempe, Arizona, 85283, United States

Location

Celerion, Lincoln

Lincoln, Nebraska, 68502, United States

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: September 22, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 14, 2026
• Study Completion (Estimated): December 14, 2026
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

US (2)