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

NCT02870231 | Completed Phase 1 FDA Drug

• 2 other identifiers: NN9030-4130U1111-1175-7040
• Study Type: interventional
• Target: 187
• Locations: 1 country
• Sites: 2

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

Conditions

Metabolism and Nutrition Disorder; Obesity

Outcome Measures

Primary Outcomes (1)

• Number of treatment emergent adverse events

  Day 1-112

Secondary Outcomes (3)

• 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

Study Arms (2)

NNC9204-0530 / Placebo and Liraglutide 1.8

EXPERIMENTAL

Drug: NNC9204-0530; Drug: liraglutide; Drug: placebo

NNC9204-0530 /Placebo and Liraglutide 3.0

ACTIVE COMPARATOR

Drug: NNC9204-0530; Drug: liraglutide; Drug: placebo

Interventions

NNC9204-0530 DRUG

Once-daily subcutaneous (s.c., under the skin) administration.

NNC9204-0530 / Placebo and Liraglutide 1.8; NNC9204-0530 /Placebo and Liraglutide 3.0

liraglutide DRUG

Once-daily subcutaneous (s.c., under the skin) administration.

NNC9204-0530 / Placebo and Liraglutide 1.8; NNC9204-0530 /Placebo and Liraglutide 3.0

placebo DRUG

Once-daily subcutaneous (s.c., under the skin) administration

NNC9204-0530 / Placebo and Liraglutide 1.8; NNC9204-0530 /Placebo and Liraglutide 3.0

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (2)

Novo Nordisk Investigational Site

Tempe, Arizona, 85283, United States

Location

Novo Nordisk Investigational Site

Lincoln, Nebraska, 68502, United States

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Nutrition Disorders; Obesity

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2016
• First Posted: August 17, 2016
• Study Start: August 18, 2016
• Primary Completion: September 3, 2017
• Study Completion: September 3, 2017
• Last Updated: September 5, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share

Locations

US (2)