NNC0487-0111 History and Updates

64 events · 2022 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: .

0
FDA Approvals
0
Label Revisions
64
Trial Milestones
0
Pivotal Publications
NNC0487-0111 — history and updatesFDA approvals, label revisions, recalls, trials, and pivotal publicationsFDA approvalsLabel revisionsRecalls + safetyTrialsPublications202220232024202520262027202820292030Trial: NCT07400107 2026-05-20 → 2028-12-12 (primary completion)Trial: NCT07567001 2026-05-11 → 2029-07-23 (primary completion)Trial: NCT07571109 2026-05-05 → 2028-06-26 (primary completion)Trial: NCT07571005 2026-05-05 → 2028-07-12 (primary completion)Trial: NCT07503210 2026-04-21 → 2028-06-06 (primary completion)Trial: NCT07533175 2026-04-13 → 2028-08-07 (primary completion)Trial: NCT07481630 2026-04-13 → 2028-08-14 (primary completion)Trial: NCT07509307 2026-04-13 → 2028-08-14 (primary completion)Trial: NCT07535307 2026-04-10 → 2027-11-11 (primary completion)Trial: NCT07508020 2026-03-30 → 2028-01-19 (primary completion)Trial: NCT07339423 2026-02-24 → 2029-06-26 (primary completion)Trial: NCT07121153 2025-08-11 → 2025-12-20 (primary completion)Trial: NCT06820476 2025-02-09 → 2025-05-14 (primary completion)Trial: NCT06559527 2024-08-20 → 2025-02-24 (primary completion)Trial: NCT06542874 2024-08-07 → 2025-10-01 (primary completion)Trial: NCT06478563 2024-06-27 → 2025-06-05 (primary completion)Trial: NCT06461039 2024-06-14 → 2025-03-16 (primary completion)Trial: NCT06064006 2023-09-15 → 2024-11-27 (primary completion)Trial: NCT06049329 2023-09-14 → 2023-12-15 (primary completion)Trial: NCT05369390 2022-05-11 → 2024-01-09 (primary completion)today (2026-06-10)FDA approvalLabel revisionRecall or safetyTrial activityPivotal publication

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-10Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for NNC0487-0111 since 2022, drawn from openFDA, ClinicalTrials.gov, and PubMed.

Upcoming & expected milestones

Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT07587710
A Research Study Looking Into Blood Levels of the Medicine NNC0487-0111 in the Body and How Well it is Tolerated in People With Reduced Live
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT07508020
A Research Study Looking at How NNC0487-0111 Affects Food Intake, Appetite and Metabolism After Meals in People With Obesity
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT07533175
AMAZE 2: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Type 2 Diabetes Lose Wei
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT07503210
AMAZE 12: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight Maintain Their Weight Loss
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT07509307
AMAZE 6: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee Osteoarthritis Lose
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT07571109
AMAZE 4: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Obstructive Sleep Apnoea
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT07571005
AMAZE 3: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Obstructive Sleep Apnoea
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT07533175
AMAZE 2: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Type 2 Diabetes Lose Wei
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT07509307
AMAZE 6: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee Osteoarthritis Lose
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT07481630
A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee Osteoarthritis Lose Weight a
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT07400107
AMAZE 8: A Research Study Investigating How Well the Medicine NNC0487-0111 Compared to Semaglutide Helps People With Excess Body Weight and
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT07339423
AMAZE 1: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight Lose Weight
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT07567001
A Research Study to Look at How Well NNC0487-0111 Works Compared to Placebo in People With Heart Failure and Obesity

Past events

2026
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT07400107
AMAZE 8: A Research Study Investigating How Well the Medicine NNC0487-0111 Compared to Semaglutide Helps People With Excess Body Weight and
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT07567001
A Research Study to Look at How Well NNC0487-0111 Works Compared to Placebo in People With Heart Failure and Obesity
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT07571109
AMAZE 4: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Obstructive Sleep Apnoea
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT07571005
AMAZE 3: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Obstructive Sleep Apnoea
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT07503210
AMAZE 12: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight Maintain Their Weight Loss
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT07533175
AMAZE 2: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Type 2 Diabetes Lose Wei
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT07481630
A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee Osteoarthritis Lose Weight a
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT07509307
AMAZE 6: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee Osteoarthritis Lose
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT07508020
A Research Study Looking at How NNC0487-0111 Affects Food Intake, Appetite and Metabolism After Meals in People With Obesity
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT07339423
AMAZE 1: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight Lose Weight
2025
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT07121153
A Research Study on How NNC0487-0111, a New Medicine, Works in Chinese Participants When Injected Under the Skin.
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT06542874
A Research Study Comparing How Well Different Doses of the Medicine NNC0487-0111 Lower Blood Sugar in People With Type 2 Diabetes
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT07121153
A Research Study on How NNC0487-0111, a New Medicine, Works in Chinese Participants When Injected Under the Skin.
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT06478563
A Research Study Looking at Different Oral Formulations and the Effect of Food Intake on How the Medicine NNC0487-0111 Behaves in the Body o
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT06820476
A Research Study on How NNC0487-0111, a New Medicine, Works in Chinese Participants After 10 Days of Oral Dosing
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT06461039
A Research Study Looking at How the Compound NNC0487-0111 Works With Birth Control Pills and Affects Emptying of the Stomach in Women Not Ab
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT06559527
A Research Study Looking Into Blood Levels of the Medicine NNC0487-0111 in the Body and How Well it is Tolerated in Participants With Reduce
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT06820476
A Research Study on How NNC0487-0111, a New Medicine, Works in Chinese Participants After 10 Days of Oral Dosing
2024
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT06064006
A Research Study to See How a New Medicine (NNC0487-0111) Works in People With Overweight or Obesity When Injected Under the Skin
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT06559527
A Research Study Looking Into Blood Levels of the Medicine NNC0487-0111 in the Body and How Well it is Tolerated in Participants With Reduce
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT06542874
A Research Study Comparing How Well Different Doses of the Medicine NNC0487-0111 Lower Blood Sugar in People With Type 2 Diabetes
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT06478563
A Research Study Looking at Different Oral Formulations and the Effect of Food Intake on How the Medicine NNC0487-0111 Behaves in the Body o
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT06461039
A Research Study Looking at How the Compound NNC0487-0111 Works With Birth Control Pills and Affects Emptying of the Stomach in Women Not Ab
2023
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT06049329
A Research Study of How a New Medicine Called Amycretin, Given as Tablets, Works in Japanese Men With Obesity
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT06064006
A Research Study to See How a New Medicine (NNC0487-0111) Works in People With Overweight or Obesity When Injected Under the Skin
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT06049329
A Research Study of How a New Medicine Called Amycretin, Given as Tablets, Works in Japanese Men With Obesity
2022

Sources

FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.