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GLP-1 and Amylin Analog

NNC0487-0111 for Obesity

Phase 1
Waitlist Available
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 between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up part a: from pre-dose on day 1 to 22 days; part b: from pre-dose on day 1 to 31 days; part c and d: from pre-dose on day 1 to 105 days
Awards & highlights

Study Summary

This trial tests a new medicine, NNC0487-0111, which is similar to 2 hormones produced in the human body. The purpose of the trial is to determine if the medicine is safe and how it affects body weight. The trial will have 4 parts, each testing a different aspect of the medicine.

Who is the study for?
This trial is for adults aged 18-55 with a BMI of 25.0 to 39.9 kg/m^2, who are in good health based on medical history, physical exams, and lab tests. It's not for those with certain blood or enzyme abnormalities or other conditions that could risk safety or protocol adherence.Check my eligibility
What is being tested?
The study is testing NNC0487-0111, a new medication mimicking hormones amylin and GLP-1 to help reduce body weight by making people feel full. Participants will receive either the drug or placebo in various dosages over single doses up to a daily dose for 12 weeks.See study design
What are the potential side effects?
While specific side effects aren't listed here, participants will be closely monitored for any adverse reactions due to the medicine's similarity to natural hormones which can affect digestion, blood sugar levels, and appetite.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~part a: from pre-dose on day 1 to 22 days; part b: from pre-dose on day 1 to 31 days; part c and d: from pre-dose on day 1 to 105 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and part a: from pre-dose on day 1 to 22 days; part b: from pre-dose on day 1 to 31 days; part c and d: from pre-dose on day 1 to 105 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
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
Part B: AUC0-24h,MD; the area under the NNC0487-011 plasma concentration-time curve from time 0 to 24 hours after last multiple dose
+3 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Part DExperimental Treatment2 Interventions
Participants will receive NNC0487-0111 B or matching placebo once-daily for 12 weeks: 3 or 6 mg for weeks 1-2, 6 or 12 mg for weeks 3-4, 12 or 25 mg for weeks 5-6, 25 or 50 mg for weeks 7-8, 25 or 50 mg for weeks 9-10 and 50 or 2*50 mg for weeks 11-12.
Group II: Part CExperimental Treatment2 Interventions
Participants will receive NNC0487-0111 A or matching placebo once-daily for 12 weeks: 3 or 6 mg for weeks 1-2, 6 or 12 mg for weeks 3-4, 12 or 25 mg for weeks 5-6, 25 or 50 mg for weeks 7-8, 25 or 50 mg for weeks 9-10 and 50 or 2*50 mg for weeks 11-12.
Group III: Part B: Multiple ascending dose (MAD)Experimental Treatment2 Interventions
Participants will receive NNC0487-0111 once daily for 10 days at any of the five different dose levels (3, 6, 12, 25 and 50 milligrams (mg)) of NNC0487-0111 A or matching placebo in a sequential manner with the dose increasing between cohorts.
Group IV: Part A: Single ascending dose (SAD)Experimental Treatment2 Interventions
Participants will receive a single dose of any of the six different dose levels (1, 3, 6, 12, 25 and 50 milligrams (mg)) of NNC0487-0111 A or matching placebo in a sequential manner with the dose increasing between cohorts.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NNC0487-0111 A
2022
Completed Phase 1
~150
NNC0487-0111 B
2022
Completed Phase 1
~150

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,513 Previous Clinical Trials
2,414,885 Total Patients Enrolled
141 Trials studying Obesity
131,894 Patients Enrolled for Obesity

Media Library

NNC0487-0111 A (GLP-1 and Amylin Analog) Clinical Trial Eligibility Overview. Trial Name: NCT05369390 — Phase 1
Obesity Research Study Groups: Part C, Part B: Multiple ascending dose (MAD), Part A: Single ascending dose (SAD), Part D
Obesity Clinical Trial 2023: NNC0487-0111 A Highlights & Side Effects. Trial Name: NCT05369390 — Phase 1
NNC0487-0111 A (GLP-1 and Amylin Analog) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05369390 — Phase 1
Obesity Patient Testimony for trial: Trial Name: NCT05369390 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research study accommodating participants who are of advanced age?

"Interested participants must be aged 18 or older, and no more than 55 years old."

Answered by AI

Has NNC0487-0111 undergone the necessary regulatory approval to be marketed in the U.S.?

"The safety of NNC0487-0111 A has been assessed as a score of 1, due to the preliminary nature of this Phase 1 trial which provides limited evidence in support of its efficacy and security."

Answered by AI

Is it possible to participate in this investigation?

"For this research, the target population is individuals with obesity aged 18 to 55. To meet the eligibility requirements for participating in this trial, applicants must have a BMI of 27-39.9 kg/m^2 at screening and 25-34.9kg/m^2 upon enrollment; additionally they should be considered fit based on their medical history as well as physical exams, vital signs readings, electrocardiograms and laboratory tests results conducted during screening visit by investigators."

Answered by AI

What is the current enrollment for this research trial?

"Affirmative. According to clinicaltrials.gov, this research study is actively enrolling participants; the initial posting was made on May 11th 2022 and updated a couple of weeks later on the 24th. The medical trial requires 116 patients from one centre alone."

Answered by AI

Are there still opportunities to join this clinical experiment?

"Yes, according to clinicaltrials.gov the trial is currently open for enrollment. This study was first published on May 11th 2022 and recently updated on May 24th 2022. The research aims to recruit 116 patients at a single site."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
Virginia
Texas
How old are they?
18 - 65
What site did they apply to?
Novo Nordisk Investigational Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
0

What questions have other patients asked about this trial?

How long is the trial? when does it start? Is this a pill or a shot?
PatientReceived 1 prior treatment

Why did patients apply to this trial?

How muchvdoes it pay. Weight lose, helped needed. I have been reading positive outcomes from novo nordisk trials on oral semiglutide and can not wait to start.
PatientReceived 1 prior treatment
Looking for a clinical trial for a GLP-1 type drug. Had initial success on Saxenda. Medicare won't cover. Slowly gaining back.
PatientReceived 2+ prior treatments
I've been trying to lose weight for years. Ive stopped putting in time and effort. I saw a lady on a talk show got accepted into a trial for another drug and lost 200 lbs. Im tired of being FAT.
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Novo Nordisk Investigational Site: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
A Research Study on How NNC0487-0111 Works in People With Overweight or Obesity
2022. "A Research Study on How NNC0487-0111 Works in People With Overweight or Obesity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05369390.
~49 spots leftby Apr 2025
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