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CompletedNCT02568306Updated Jul 13, 2018

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

A Phase 1 interventional study of NNC0165-1562 and placebo in Metabolism and Nutrition Disorder and Obesity, sponsored by Novo Nordisk A/S. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-13.

Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Feb 2017, 9 years 8 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
93
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
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Study 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.

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Conditions studied

  • Metabolism and Nutrition Disorder
  • Obesity
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In context

Nutrition Disorders

279 studies on the registry are indexed under Nutrition Disorders; 31 are open to participants now.

This study's enrollment of 93 is below the median of 115 across 198 interventional studies indexed under Nutrition Disorders.

Browse Nutrition Disorders studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,401 studies on the registry; 102 are open to participants now.

Of its 204 completed or terminated interventional studies of FDA-regulated products, 98 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Investigator)
Enrollment
93 participants (actual)

Study arms

  • Experimental
    NNC0165-1562

    Drug: NNC0165-1562

  • Placebo comparator
    Placebo

    Drug: placebo

Interventions

  • DrugNNC0165-1562

    Administered subcutaneously (s.c., under the skin) single dose \[SD\] or multiple dose \[MD\] with daily dosing.

  • Drugplacebo

    Administered subcutaneously (s.c., under the skin) single dose \[SD\]) or multiple dose \[MD\] with daily dosing.

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What researchers measure

Primary outcomes

  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 outcomes

  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)

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Study locations

1 site
  • Novo Nordisk Investigational Site
    Tempe, Arizona 85283, United States
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References and documents

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2015 to primary completion in Feb 2017, 16 months.

Of 21 phase 1 interventional studies under Nutrition Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 16. This study's 16 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 2, 2015
First posted
Oct 5, 2015
StartActual
Oct 5, 2015
Primary completionActual
Feb 7, 2017
CompletionActual
Feb 7, 2017
Last update
Jul 13, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 13, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02568306
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Oct 5, 2015
Start date
Oct 5, 2015
Primary completion
Feb 7, 2017
Completion
Feb 7, 2017
Last update
Jul 13, 2018

Study contacts

Global Clinical Registry (GCR, 1452)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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