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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

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ClinicalTrials.gov Identifier: NCT02568306
Recruitment Status : Completed
First Posted : October 5, 2015
Last Update Posted : July 13, 2018
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

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

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Study Type : Interventional  (Clinical Trial)
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 : October 5, 2015
Actual Primary Completion Date : February 7, 2017
Actual Study Completion Date : February 7, 2017

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.




Primary Outcome Measures :
  1. Number of treatment emergent adverse events (TEAEs), Part I (SD) [ Time Frame: From time of dosing (Day1) until completion of the follow-up visit (Day 29) ]
  2. Number of TEAEs, Part II (MD) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: From baseline (Day 1) until the follow-up visit (Day 85) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02568306


Locations
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United States, Arizona
Novo Nordisk Investigational Site
Tempe, Arizona, United States, 85283
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02568306    
Other Study ID Numbers: NN9747-4194
U1111-1164-6546 ( Other Identifier: WHO )
First Posted: October 5, 2015    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: July 2018

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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:
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Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms