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NNC0487-0111 for Obesity

Phase 1
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
Aged 18-55 years (both inclusive) at the time of signing informed consent
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from pre-dose on v33 day1 until v34, up to 9 days
Awards & highlights

Study Summary

This trial tests a new drug to see if it's safe & how it works in the body when given as injections.

Who is the study for?
This trial is for men and women aged 18-55 with a BMI between 27.0 and 39.9, indicating overweight due to excess fat as assessed by the study's doctor. Participants must pass health checks including vital signs, heart tests, and lab tests. Those with conditions affecting safety or protocol adherence, high blood sugar levels (HbA1c ≥6.5%), very low vitamin D, abnormal parathyroid hormone or calcium levels, or significantly elevated amylase/lipase/calcitonin are excluded.Check my eligibility
What is being tested?
The trial is testing NNC0487-0111, a new drug given as an under-the-skin injection to see if it's safe and how it works in people with obesity compared to a placebo (a substance with no active drug).See study design
What are the potential side effects?
While specific side effects of NNC0487-0111 aren't listed here, common ones for new obesity treatments can include nausea, headaches, digestive issues like diarrhea or constipation; reactions at the injection site; fatigue; and dizziness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 55 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from pre-dose on v33 day1 until v34, up to 9 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and from pre-dose on v33 day1 until v34, up to 9 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
PART A: Number of treatment emergent adverse events (TEAE)
Parts B and C: Number of treatment emergent adverse events (TEAE)
Secondary outcome measures
PART A: AUC0-∞,SD; the area under the NNC0487-0111 plasma concentration-time curve from time 0 to infinity after a single dose
PART A: Cmax,SD; the maximum plasma concentration of NNC0487-0111 after a single dose and the corresponding time tmax
Parts B and C: Cmax,SS; the maximum plasma concentration of NNC0487 0111 after last multiple dose and the corresponding time tmax
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: NNC0487-0111Experimental Treatment2 Interventions
Participants will be randomized to receive NNC0487-0111. The study will be conducted in 3 parts. Part A: Single ascending dose (SAD) Part B and C: Multiple ascending dose (MAD)
Group II: PlaceboPlacebo Group2 Interventions
Participants will be randomized to receive Placebo. The study will be conducted in 3 parts. Part A: Single ascending dose (SAD). Part B and C: Multiple ascending dose (MAD).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NNC0487-0111
2023
Completed Phase 1
~40
Placebo (NNC0487-0111)
2023
Completed Phase 1
~40

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,514 Previous Clinical Trials
2,414,984 Total Patients Enrolled
141 Trials studying Obesity
131,954 Patients Enrolled for Obesity
Clinical Transparency dept. 2834Study DirectorNovo Nordisk A/S
36 Previous Clinical Trials
522,922 Total Patients Enrolled
3 Trials studying Obesity
551 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 enrollment still available for the clinical trial?

"Affirmative. Clinicaltrials.gov displays that enrollment for this trial is open, which was first advertised on September 15th 2023 and recently updated the 28th of September 2023. This research necessitates 84 participants across a single site."

Answered by AI

Does this research encompass participants aged 65 and over?

"This medical experiment only permits individuals aged 18 to 55. However, there are 197 trials meant for minors and 748 studies intended for the elderly population."

Answered by AI

Could you elaborate on the security concerns associated with NNC0487-0111 usage?

"A Phase 1 trial suggests that there is limited data available for both safety and efficacy, which earned NNC0487-0111 a score of 1."

Answered by AI

What is the cap on participation for this therapeutic trial?

"Verified. The clinicaltrials.gov portal demonstrates that this medical trial, first shared on September 15th 2023 is actively recruiting participants. They are looking for 84 patients from one location to join the study."

Answered by AI

Do I meet the qualifications to participate in this research project?

"To qualify, potential participants must possess obesity and be within the 18-55 year old age range. 84 subjects are needed for this trial to reach its full capacity."

Answered by AI

What objectives is this trial hoping to accomplish?

"As per the clinical trial sponsor, Novo Nordisk A/S, the main assessment to be conducted over a 24-day period will track any treatment-emergent adverse events. Secondary measurements recorded include CmaxSD (maximum plasma concentration of NNC0487-0111 after single dose), AUC (area under the NNC0487-0111 plasma concentration time curve) and CmaxSS (maximum plasma concentration of NNC0487 0111 after last multiple dose)."

Answered by AI

Who else is applying?

What site did they apply to?
Novo Nordisk Investigational Site
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I was on Wegovy for a 8 months and stopped as I lost 11 lbs. I need help and have tried multiple diets, prescription and over the counter meds.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A Research Study to See How a New Medicine (NNC0487-0111) Works in People With Overweight or Obesity When Injected Under the Skin
2023. "A Research Study to See How a New Medicine (NNC0487-0111) Works in People With Overweight or Obesity When Injected Under the Skin". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06064006.
All > Overweight
~39 spots leftby Oct 2024
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