NCT03015207

Brief Summary

This trial is conducted in The United States of America. The aim of this trial is to investigate Safety, Tolerability and Pharmacokinetics (the exposure of the trial drug in the body) of NNC0194-0499 in Male Subjects with Overweight or Obesity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

January 6, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 9, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 26, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2017

Completed
Last Updated

September 5, 2018

Status Verified

September 1, 2018

Enrollment Period

10 months

First QC Date

January 6, 2017

Last Update Submit

September 3, 2018

Conditions

Metabolism and Nutrition DisorderObesity

Outcome Measures

Primary Outcomes (1)

  • Number of treatment-emergent adverse events (TEAEs)

    From time of administration of NNC0194-0499 (day 1) to completion of the post-treatment period at follow-up (day 36)

Secondary Outcomes (3)

  • The area under the NNC0194-0499 serum concentration-time curve after a single subcutaneous administration

    From pre-dose (day 1) until the followup (day 36)

  • The maximum concentration of NNC0194-0499 in serum after a single subcutaneous administration

    From pre-dose (day 1) until the followup (day 36)

  • The time to maximum concentration of NNC0194-0499 in serum after a single subcutaneous administration

    From pre-dose (day 1) until the followup (day 36)

Study Arms (2)

NNC0194-0499

EXPERIMENTAL

Injected s.c. /subcutaneously (under the skin)

Drug: NNC0194-0499

Placebo

PLACEBO COMPARATOR

Injected s.c. /subcutaneously (under the skin)

Drug: Placebo

Interventions

NNC0194-0499DRUG
NNC0194-0499
PlaceboDRUG
Placebo

Eligibility Criteria

Age22 Years - 55 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male, aged 22-55 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 adipose tissue, as judged by the investigator

You may not qualify if:

  • Any concomitant illness or disorder, which in the investigator's opinion might jeopardise the subject's safety or compliance with the protocol
  • Subjects aged above or equal to 40 years with an estimated 10-year atherosclerotic cardiovascular disease (ASCVD according to ACC/AHA (American College of Cardiology /American Heart Association) guideline) risk above or equal to 5%
  • Male subjects who are not sexually abstinent or surgically sterilised (vasectomy) and are sexually active with female partner(s) and 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 below 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 (visit 1) until 3 months following administration of the investigational medical product
  • Use of prescription or non-prescription medicinal products including herbal products and non-routine vitamins, within 2 weeks prior to screening, with the exception of occasional use of acetaminophen, ibuprofen or acetylsalicylic acid

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

San Antonio, Texas, 78209, United States

Location

Related Publications (1)

  • Dahl K, Friedrichsen MH, Ribel-Madsen R, Hansen JS, Clausen JO, Axelsen M, Palle MS, Lippert SL, Bjorkdahl O, Toubro S, Key C, Andersen B. Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Novel Long-Acting FGF21 Analog Zalfermin. Clin Transl Sci. 2025 Dec;18(12):e70435. doi: 10.1111/cts.70435.

    PMID: 41351276DERIVED

MeSH Terms

Conditions

Nutrition DisordersObesity

Condition Hierarchy (Ancestors)

Nutritional and Metabolic DiseasesOverweightOvernutritionBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Global Clinical Registry (GCR,1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

January 6, 2017

First Posted

January 9, 2017

Study Start

January 6, 2017

Primary Completion

October 26, 2017

Study Completion

October 26, 2017

Last Updated

September 5, 2018

Record last verified: 2018-09

Locations

US(1)