Part C for Obesity

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Novo Nordisk Investigational Site, San Antonio, TX
Obesity+1 More
NNC0487-0111 A - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

NNC0487-0111 is a new medicine similar to 2 hormones that are produced in human body: amylin and glucagon-like peptide-1 (GLP-1). Both hormones work like body's own hormones and help the body to feel full. This study tests if the study medicine is safe and to find out how the medicine works in humans. This study also look at how the study medicine affects body weight and how to improve the treatment of people with overweight, obesity or related diseases. This study will have 4 parts: Part A, B, C and D. Part A: This is planned to consist of five groups, one additional group may be added. Each group will include 8 participants, with 6 participants being randomised to receive a single dose of NNC0487-0111 A and 2 participants randomised to receive placebo. The dosing within each group will be sequential, i.e., 2 sentinel participants (1 on active and 1 on placebo). Part B: This is planned to consist of three groups, one additional group may be added. Each group will include 12 participants, with 9 participants being randomised to receive NNC0487-0111 A and 3 participants randomised to receive placebo once daily for 10 days. The dosing within each group will be sequential. For the first group, 4 sentinel participants (3 on active and 1 on placebo) will be dosed followed by a safety observation period of 7 days (168 hours), before dosing of the remaining participants in the group will be initiated. For the remaining groups, 4 sentinel participants (3 on active and 1 on placebo) will be dosed followed by a safety observation period of at least 36 hours before dosing of the remaining participants in the group will be initiated. Part C and D are matching regarding planned visits and procedures, but the study interventions in Part D (NNC0487-0111 B) differ from Part A, B and C (NNC0487-0111 A). Each part is planned to consist of one group, although one additional group may be added. Each group will include 20 participants, with 16 participants being randomised to receive active treatment and 4 participants randomised to receive placebo once-daily for 12 weeks. The dosing will be sequential, i.e., 4 sentinel participants (3 on active and 1 on placebo) will be dosed followed by a safety observation period of at least 36 hours before dosing of the remaining participants in the cohort will be initiated. The remaining participants will be dosed in smaller groups of 8 participants separated by a safety observation period of at least 36 hours. A safety evaluation will be made between dosing of participants within a group and before moving on to a higher dose.

Eligible Conditions

  • Obesity

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: 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

Day 22
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
Day 11
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
Day 22
Part B: Cmax,MD; the maximum plasma concentration of NNC0487- 0111 after last multiple dose
Day 85
Part C and D: AUC0-24h,MD; the area under the NNC0487-011 plasma concentration-time curve from time 0 to 24 hours after last multiple dose
Day 105
Part C and D: Cmax,MD; the maximum plasma concentration of NNC0487- 0111 after last multiple dose
Day 105
Number of treatment emergent adverse events (TEAE)

Trial Safety

Safety Progress

1 of 3

Trial Design

4 Treatment Groups

Part C
1 of 4
Part B: Multiple ascending dose (MAD)
1 of 4
Part A: Single ascending dose (SAD)
1 of 4
Part D
1 of 4
Experimental Treatment

116 Total Participants · 4 Treatment Groups

Primary Treatment: Part C · Has Placebo Group · Phase 1

Part CExperimental Group · 2 Interventions: NNC0487-0111 A, Placebo A (NNC0487-0111 A) · Intervention Types: Drug, Other
Part B: Multiple ascending dose (MAD)Experimental Group · 2 Interventions: NNC0487-0111 A, Placebo A (NNC0487-0111 A) · Intervention Types: Drug, Other
Part A: Single ascending dose (SAD)Experimental Group · 2 Interventions: NNC0487-0111 A, Placebo A (NNC0487-0111 A) · Intervention Types: Drug, Other
Part DExperimental Group · 2 Interventions: NNC0487-0111 B, Placebo B (NNC0487-0111 B) · Intervention Types: Drug, Other

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 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
Closest Location: Novo Nordisk Investigational Site · San Antonio, TX
Photo of San Antonio  1Photo of San Antonio  2Photo of San Antonio  3
2004First Recorded Clinical Trial
87 TrialsResearching Obesity
850 CompletedClinical Trials

Eligibility Criteria

Age 18 - 65 · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are 25.0 to 34.9 kg/m^2 (BMI 25.0 to 34.
You are considered eligible for the study if you are considered to be in good health and if you are aged 18 years or older.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.