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Dosing scheme b: NNC0519-0130 for Obesity
Phase 2
Recruiting
Research Sponsored by Novo Nordisk A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline (week 0) to end of treatment (week 40)
Awards & highlights
Study Summary
This trial will investigate the effectiveness of a new medication, NNC0519-0130, in helping people with excess body weight to lose weight. Participants will receive 1-2 injections of the
Who is the study for?
This trial is for individuals with obesity looking to lose weight. Participants will be given up to 6 different doses of a new medicine, NNC0519-0130, or a placebo. The medication is administered via weekly injections under the skin.Check my eligibility
What is being tested?
The study tests the effectiveness of various doses of NNC0519-0130 in helping people lose excess body weight compared to a placebo. It involves weekly subcutaneous injections over approximately 42 weeks.See study design
What are the potential side effects?
Potential side effects are not specified here but may include reactions at the injection site, gastrointestinal issues, and other common drug-related adverse events.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline (week 0) to end of treatment (week 40)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (week 0) to end of treatment (week 40)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Relative change in body weight
Secondary outcome measures
Achievement of greater than equal to (≥) 5% weight reduction
Achievement of ≥ 10% weight reduction
Achievement of ≥ 15% weight reduction
+17 moreSide effects data
From 2022 Phase 3 trial • 210 Patients • NCT0502403240%
Diarrhoea
30%
Nausea
27%
Decreased appetite
23%
Upper respiratory tract infection
19%
Abdominal distension
11%
Gastroenteritis
11%
Vomiting
9%
Abortion induced
9%
Flatulence
7%
Abdominal pain upper
7%
Gingivitis
7%
Amylase increased
7%
Lipase increased
6%
Injection site reaction
6%
Menstruation irregular
6%
Abdominal pain
4%
Hepatic function abnormal
4%
Hyperuricaemia
3%
Uterine polyp
3%
Dizziness
3%
Vaginal infection
1%
Supraventricular tachycardia
1%
Hand fracture
1%
Hiccups
100%
80%
60%
40%
20%
0%
Study treatment Arm
10 mg Tirzepatide
15 mg Tirzepatide
Placebo
Trial Design
13Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Dosing scheme f: NNC0519-0130Experimental Treatment1 Intervention
Participants will receive NNC0519-0130 at 6 dose levels s.c. once-weekly up to 36 weeks.
Group II: Dosing scheme e: NNC0519-0130Experimental Treatment1 Intervention
Participants will receive NNC0519-0130 at 5 dose levels s.c. once-weekly up to 36 weeks.
Group III: Dosing scheme d: NNC0519-0130Experimental Treatment1 Intervention
Participants will receive NNC0519-0130 at 4 dose levels s.c. once-weekly up to 36 weeks.
Group IV: Dosing scheme c: NNC0519-0130Experimental Treatment1 Intervention
Participants will receive NNC0519-0130 at 3 dose levels s.c. once-weekly up to 36 weeks.
Group V: Dosing scheme b: NNC0519-0130Experimental Treatment1 Intervention
Participants will receive NNC0519-0130 at 2 dose levels s.c. once-weekly up to 36 weeks.
Group VI: Dosing scheme a: NNC0519-0130Experimental Treatment1 Intervention
Participants will receive NNC0519-0130 at 1 dose level subcutaneously (s.c.) once-weekly up to 36 weeks.
Group VII: Dosing scheme g: TirzepatideActive Control1 Intervention
Participants will receive tirzepatide at 6 dose levels s.c. once weekly up to 36 weeks.
Group VIII: Dosing scheme d: PlaceboPlacebo Group1 Intervention
Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.
Group IX: Dosing scheme a: PlaceboPlacebo Group1 Intervention
Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.
Group X: Dosing scheme e: PlaceboPlacebo Group1 Intervention
Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.
Group XI: Dosing scheme b: PlaceboPlacebo Group1 Intervention
Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.
Group XII: Dosing scheme f: PlaceboPlacebo Group1 Intervention
Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.
Group XIII: Dosing scheme c: PlaceboPlacebo Group1 Intervention
Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NNC0519-0130
2023
Completed Phase 1
~30
Find a Location
Who is running the clinical trial?
Novo Nordisk A/SLead Sponsor
1,515 Previous Clinical Trials
2,415,016 Total Patients Enrolled
142 Trials studying Obesity
131,986 Patients Enrolled for Obesity
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
107 Previous Clinical Trials
139,774 Total Patients Enrolled
29 Trials studying Obesity
49,473 Patients Enrolled for Obesity
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it possible for me to be enrolled as a participant in this medical study?
"To be eligible for participation, individuals must have a diagnosis of obesity and fall between 18 to 75 years old. The study aims to enroll approximately 343 participants."
Answered by AI
Are prospective patients still eligible to participate in this ongoing medical study?
"As per clinicaltrials.gov, this study is currently not in the recruitment phase. Its initial posting date was 3/18/2024 and its most recent update occurred on 3/16/2024. Despite this trial being inactive for now, there are over a thousand other trials welcoming participants at present."
Answered by AI
Has the dosing plan for NNC0519-0130 been officially authorized by the FDA?
"As we are conducting a Phase 2 trial with Dosing scheme a: NNC0519-0130, our team at Power rates its safety as a 2 on the scale of 1 to 3. This indicates that while there is some existing safety data, efficacy has not yet been established."
Answered by AI
Is the research trial open to individuals who have reached their third decade of life?
"Individuals aged 18 years and above but under 75 are eligible for enrollment in this clinical trial."
Answered by AI
At how many different venues is this experimental investigation currently being supervised?
"Holdsworth House Clinical Research in Darlinghurst, New South Wales, Family Practice Center of Wadsworth Inc. in Wadsworth, Ohio, and Lynn Institute of Norman in Norman, Oklahoma are among the 51 sites where patients can enroll for this trial."
Answered by AI
Who else is applying?
What site did they apply to?
FDRC
Lynn Institute of Norman
Centricity Research-Arizona
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Why did patients apply to this trial?
Improving my health. I ve tried every diet under the sun. I want to lose weight to improve my health.
PatientReceived no prior treatments
I am interested in losing weight and getting healthier. I have tried a few other methods of weight loss and can't seem to lose weight.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
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