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Recruiting NCT07437079

A Study to See How Safe a New Medicine (NNC6989-0001) is in Healthy People Living With Overweight or Obesity

Phase I Interventional Overweight Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NNC6989-0001, Placebo (NNC6989-0001).
Who it may be relevant to
Registry conditions: Overweight, Obesity. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A First Human Dose Study Investigating Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of Single and Multiple Ascending Doses of NNC6989-0001 in Healthy Participants With Overweight or Obesity

Overview

This study is testing a new medicine, NNC6989-0001, to test it is safe and tolerable for healthy people living with overweight or obesity. NNC6989-0001 is still being tested in studies and is not yet available for prescription by doctors. In this study, participants will receive either NNC6989-0001 or a placebo; which treatment each participant receives will be decided by chance.

Interventions

  • Drug NNC6989-0001
    Participants assigned to the active intervention receive NNC6989-0001
  • Drug Placebo (NNC6989-0001)
    Participants assigned to the placebo, receive placebo matched in appearance to the active drug.

Primary outcome measures

  • Number of treatment emergent adverse events (TEAE) - Part A [Time frame: From time of dosing on Day1 until completion of the end of study visit (Day 7)]
  • Number of treatment emergent adverse events (TEAE) - Part B [Time frame: From time of dosing on Day 1 until completion of the end of study visit (Day 14)]
  • iAUCTG; The incremental area under the blood triglycerides concentration-time curve following meal test - Part C [Time frame: Following meal test at Day -1, Day 1, Day 7 and Day 13]
Secondary outcome measures (6)
  • AUC; the area under the NNC6989-0001 plasma concentration-time curve - Part A [Time frame: From pre-dose on Day 1 until completion of the end of study visit (Day 7)]
  • Cmax; the maximum plasma concentration of NNC6989-0001 - Part A [Time frame: From pre-dose on Day 1 until completion of the end of study visit (Day 7)]
  • AUC; the area under the NNC6989-0001 plasma concentration-time curve - Part B [Time frame: From pre-dose on Day 1 until completion of the end of study visit (Day 14)]
  • Cmax; the maximum plasma concentration of NNC6989-0001 - Part B [Time frame: From pre-dose on Day 1 until completion of the end of study visit (Day 14)]
  • AUC; the area under the NNC6989-0001 plasma concentration-time curve - Part C [Time frame: From pre-dose on Day 1 until completion of the end of study visit (Day 20)]
  • Cmax; the maximum plasma concentration of NNC6989-0001 - Part C [Time frame: From pre-dose on Day 1 until completion of the end of study visit (Day 20)]

Eligibility criteria

Inclusion criteria

  • Male or female of non-childbearing potential.
  • Age 18-55 years (both inclusive) at the time of signing the informed consent.
  • Body mass index (BMI) (at screening) ≥ 25.0 and ≤ 34.9 kg/m\^2 for Part A (SAD part) and BMI (at screening) ≥ 25.0 and ≤ 39.9 kg/m\^2 for Part B (MAD part) and Part C (meal timing and potentially meal composition).
  • 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

  • Any condition, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
  • Any clinically significant body weight change (≥5 % self-reported change) or dieting attempts (e.g., participation in a weight reduction program) within 90 days before screening.
  • Treatment with any GLP-1 RA or a medication with GLP-1 activity within 90 days before screening
  • Use of prescription or non-prescription medicinal products within 14 days before screening. This includes over the counter medicines such as laxatives, mineral oil, and fat-blocking supplements. Routine multivitamin/mineral supplements at labelled daily doses are permitted; other non-prescription supplements (e.g., high-dose vitamins, weight-loss supplements) are not permitted. Occasional use of over-the-counter acetaminophen or NSAIDs at their labelled doses for mild pain is permitted.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • ICON Early Phase Services, LLC — Lenexa

Identifiers

NCT: NCT07437079 · NN6989-8611 · U1111-1326-7700

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗