A Trial Investigating Safety, Tolerability, PK and PD for Multiple Doses of NNC9204-0530 in Male and Female Subjects Being Overweight or With Obesity

A Double-blinded Placebo-controlled Multiple Dose Trial Investigating Safety, Tolerability, PK and PD for Multiple Doses of NNC9204-0530 in Male and Female Subjects Being Overweight or With Obesity

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02835235

Enrollment

Registered

2016-07-18

Start date

2016-07-26

Completion date

2017-07-07

Last updated

2018-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolism and Nutrition Disorder, Obesity

Brief summary

This trial is conducted in the United States of America. The aim of the trial is to investigate Safety, Tolerability, PK and PD for Multiple Doses of NNC9204-0530 in Male and Female Subjects being overweight or with obesity

Interventions

DRUGNNC9204-0530

Administered daily subcutaneously (s.c., under the skin)

DRUGplacebo

Administered daily subcutaneously (s.c., under the skin)

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Inclusion criteria

* Male or female, age between 18 and 55 years (both inclusive) at the time of signing informed consent * Body mass index between 25.0 and 39.9 kg/m\^2 (both inclusive) at screening.

Exclusion criteria

* Haemoglobin A1c (HbA1c) equal or above 6.5% * Any clinically significant weight change (above or equal to 5% self-reported change) or dieting attempts (e.g. participation in an organized weight reduction program) within the last 90 days prior to screening * Any prior obesity surgery or currently present gastrointestinal implant. * Abnormal ECG (electrocardiogram) results including 2nd or 3rd degree AV-block, prolongation of the QRS complex above 120 ms, or the QTcF interval above 430 ms (males) or above 450 ms (females), or other clinically relevant abnormal results, as judged by the investigator * A history of additional risk factors for Torsades de pointes (e.g., heart failure, hypokalaemia, family history of Long QT Syndrome) * History of pancreatitis (acute or chronic)

Design outcomes

Primary

Measure	Time frame
Number of treatment emergent adverse events	Day 1-112

Secondary

Measure	Time frame
Area under the NNC9204-0530 serum concentration-time curve	Day 84-112
Time to maximum serum concentration of NNC9204-0530	Day 84-112
Change in HbA1c	Day -1, Day 85

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026