A First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics for Single Doses and Multiple Doses of NNC0165-1562 in Overweight to Obese But Otherwise Healthy Subjects

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02568306
• Collaborator: (none)
• Enrollment: 93
• Location: 1
• Arms: 2
• Actual Duration (Months): 16.1
• Patients Per Site Per Month: 5.8

Study Details

Study Description

Brief Summary

This trial is conducted in the United States of America. The aim of the trial is to investigate safety, tolerability and pharmacokinetics (the exposure of the trial drug in the body) for single doses and multiple doses of NNC0165-1562 in overweight to obese but otherwise healthy subjects.

Condition or Disease	Intervention/Treatment	Phase
Metabolism and Nutrition Disorder; Obesity	Drug: NNC0165-1562; Drug: placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 93 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics for Single Doses and Multiple Doses of NNC0165-1562 in Overweight to Obese But Otherwise Healthy Subjects.
• Actual Study Start Date: Oct 5, 2015
• Actual Primary Completion Date: Feb 7, 2017
• Actual Study Completion Date: Feb 7, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NNC0165-1562	Drug: NNC0165-1562; Administered subcutaneously (s.c., under the skin) single dose [SD] or multiple dose [MD] with daily dosing.
Placebo Comparator: Placebo	Drug: placebo; Administered subcutaneously (s.c., under the skin) single dose [SD]) or multiple dose [MD] with daily dosing.

Outcome Measures

Primary Outcome Measures

1. Number of treatment emergent adverse events (TEAEs), Part I (SD) [From time of dosing (Day1) until completion of the follow-up visit (Day 29)]

2. Number of TEAEs, Part II (MD) [From time of dosing (Day 1) until completion of the follow-up visit (Day 85)]

Secondary Outcome Measures

1. The area under the NNC0165-1562 plasma concentration-time curve, Part I (SD) [From time 0 to 24 hours after a single s.c. dose. From baseline (Day 1) until the follow-up visit (Day 29)]

2. The maximum plasma concentration of NNC0165-1562 after a single s.c. dose, Part I (SD) [From baseline (Day 1) until the follow-up visit (Day 29)]

3. The time to maximum plasma concentration of NNC0165-1562 after a single s.c.dose, Part I (SD) [From baseline (Day 1) until the follow-up visit (Day 29)]

4. The area under the NNC0165-1562 plasma concentration-time curve, Part II (MD) [From time 0 to 24 hours at steady state. From baseline (Day 1) until the follow-up visit (Day 85)]

5. The maximum plasma concentration of NNC0165-1562 at steady state, Part II (MD) [From baseline (Day 1) until the follow-up visit (Day 85)]

6. The time to maximum plasma concentration of NNC0165-1562 at steady state, Part II (MD) [From baseline (Day 1) until the follow-up visit (Day 85)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Part I (SD):

• Male, aged 18-55 years (both inclusive) at the time of signing informed consent

• Body mass index (BMI) between 25.0 and 34.9 kg/m^2 (both inclusive). Overweight should be due to excess of adipose tissue, as judged by the investigator

• Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator

• Part II (MD):

• Male or female, aged 18-55 years (both inclusive) at the time of signing informed consent

• Body mass index (BMI) between 27.0 and 39.9 kg/m^2 (both inclusive). Overweight should be due to excess of adipose tissue, as judged by the investigator

• Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator

Exclusion Criteria:

• Any clinically significant weight change (at least 5% self-reported change during the previous 3 months), dieting attempts (e.g. participation in an organised weight reduction programme within the last 3 months), prior obesity surgery, or medications affecting body weight within 3 months prior to screening

• Male subjects who are not surgically sterilised (vasectomy) and are sexually active with female partner(s) who are not using a highly effective method of contraception (such as condom with spermicide) combined with a highly effective method of contraception for their non-pregnant female partner(s) (Pearl Index 1%, such as implants, injectables, oral contraceptives, intrauterine devices, diaphragm or cervical cap+spermicide), and/or intend to donate sperm in the period from screening until 3 months following administration of the investigational medical product

• Female subjects who are of child bearing potential (pre-menopausal and not surgically sterilised) and are sexually active with male partner(s) who are not surgically sterilised (vasectomy) and are not using highly effective contraceptive methods (Pearl Index 1%,such as implants, injectables, oral contraceptives, intrauterine devices, diaphragm or cervical cap+spermicide) combined with a highly effective method of contraception for their male partner(s) (e.g. condom with spermicide), and/or are pregnant, breast-feeding or intend to become pregnant) (applicable to Part II (MD) only)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Tempe	Arizona	United States	85283

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

• Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Clinical Trials at Novo Nordisk

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT02568306
• Other Study ID Numbers: NN9747-4194; U1111-1164-6546
• First Posted: Oct 5, 2015
• Last Update Posted: Jul 13, 2018
• Last Verified: Jul 1, 2018

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Nutrition Disorders; Overweight

Study Results

No Results Posted as of Jul 13, 2018