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

Phase 1

Completed

• Conditions: Metabolism and Nutrition Disorder; Obesity
• Interventions: Drug: NNC9204-0530; Drug: liraglutide; Drug: placebo

• Registration Number: NCT02870231
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in the United States of America. The aim of this trial is to investigate Safety, Tolerability, PK (the exposure of the trial drug in the body) and PD (the effect of the investigated drug on the body) for Multiple Doses of NNC9204-0530 in Combination with Liraglutide in Male and Female Subjects being Overweight or with Obesity

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-12
• Study First Submitted QC: 2016-08-12
• Study First Posted: 2016-08-17
• Study Start: 2016-08-18
• Primary Completion: 2017-09-03
• Study Completion: 2017-09-03
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-03
• Last Update Posted: 2018-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 187

Inclusion Criteria

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

Exclusion Criteria

• Any clinically significant weight change (equal or above 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.
• Thyroid-stimulating hormone (TSH) values outside 0.4-6.0 mIU/L
• Glycosylated haemoglobin (HbA1c)above or equal to 6.5% or in Système International (SI) units 48 mmol/mol
• 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)
• Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2)
• Calcitonin above or equal to 50 ng/L
• History of pancreatitis (acute or chronic)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NNC9204-0530 / Placebo and Liraglutide 1.8	NNC9204-0530	-
NNC9204-0530 / Placebo and Liraglutide 1.8	placebo	-
NNC9204-0530 /Placebo and Liraglutide 3.0	NNC9204-0530	-
NNC9204-0530 /Placebo and Liraglutide 3.0	liraglutide	-
NNC9204-0530 /Placebo and Liraglutide 3.0	placebo	-
NNC9204-0530 / Placebo and Liraglutide 1.8	liraglutide	-

Primary Outcome Measures

Name	Time	Method
Number of treatment emergent adverse events	Day 1-112

Secondary Outcome Measures

Name	Time	Method
Change in HbA1C	Day -1, Day 85
Time to maximum serum concentration of NNC9204-0530	Day 84-112
Area under the NNC9204-0530 serum concentration-time curve	Day 84-112

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇺🇸 Lincoln, Nebraska, United States