Trial Outcomes & Findings for A Study to Evaluate Efficacy and Safety of AMZ001 for the Treatment of Knee Osteoarthritis Symptoms (NCT NCT06693648)

Last Updated: 2026-07-15

Results Overview

Change from baseline in the WOMAC pain sub-score in the target knee at week 2. WOMAC: Western Ontario and McMasters University Osteoarthritis Index Participants will answer all of the 5 questions of WOMAC pain sub-score for themselves, using an 11-box numerical rating scale (with categories of 0 to 10), with reference to the past 24 hours. For convenience and ease of interpretation, total WOMAC pain sub-score will be normalized on scales of 0 to 100 points. Scale: 0-100, 100 being the worse

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

549 participants

Primary outcome timeframe

Baseline and Week 2

Results posted on

2026-07-15

Participant Flow

Participant milestones

Participant milestones
Measure	AMZ001 Diclofenac Gel AMZ001 diclofenac gel once daily	Placebo Gel Placebo gel once daily
Overall Study STARTED	272	277
Overall Study COMPLETED	256	253
Overall Study NOT COMPLETED	16	24

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Evaluate Efficacy and Safety of AMZ001 for the Treatment of Knee Osteoarthritis Symptoms

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AMZ001 Diclofenac Gel n=272 Participants AMZ001 diclofenac gel once daily	Placebo Gel n=276 Participants Placebo gel once daily	Total n=548 Participants Total of all reporting groups
Age, Continuous	63.4 years STANDARD_DEVIATION 9.3 • n=20 Participants	64.0 years STANDARD_DEVIATION 8.5 • n=20 Participants	63.7 years STANDARD_DEVIATION 8.9 • n=40 Participants
Sex: Female, Male Female	192 Participants n=20 Participants	185 Participants n=20 Participants	377 Participants n=40 Participants
Sex: Female, Male Male	80 Participants n=20 Participants	91 Participants n=20 Participants	171 Participants n=40 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	33 Participants n=20 Participants	33 Participants n=20 Participants	66 Participants n=40 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	236 Participants n=20 Participants	242 Participants n=20 Participants	478 Participants n=40 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=20 Participants	1 Participants n=20 Participants	4 Participants n=40 Participants
Race/Ethnicity, Customized Asian	50 Participants n=20 Participants	47 Participants n=20 Participants	97 Participants n=40 Participants
Race/Ethnicity, Customized Black or African American	38 Participants n=20 Participants	35 Participants n=20 Participants	73 Participants n=40 Participants
Race/Ethnicity, Customized White	183 Participants n=20 Participants	192 Participants n=20 Participants	375 Participants n=40 Participants
Race/Ethnicity, Customized Other	0 Participants n=20 Participants	2 Participants n=20 Participants	2 Participants n=40 Participants
Race/Ethnicity, Customized Not reported	1 Participants n=20 Participants	0 Participants n=20 Participants	1 Participants n=40 Participants

PRIMARY outcome

Timeframe: Baseline and Week 2

Outcome measures

Outcome measures
Measure	AMZ001 Diclofenac Gel n=272 Participants AMZ001 diclofenac gel once daily	Placebo Gel n=276 Participants Placebo gel once daily
Change From Baseline in the WOMAC Pain Sub-score in the Target Knee at Week 2.	-21.17 Scores on a scale Interval -23.22 to -19.12	-19.64 Scores on a scale Interval -21.66 to -17.61

SECONDARY outcome

Timeframe: Baseline and Week 1

Change from baseline in the WOMAC pain sub-score in the target knee at week 1. WOMAC: Western Ontario and McMasters University Osteoarthritis Index Participants will answer all of the 5 questions of WOMAC pain sub-score for themselves, using an 11-box numerical rating scale (with categories of 0 to 10), with reference to the past 24 hours. For convenience and ease of interpretation, total WOMAC pain sub-score will be normalized on scales of 0 to 100 points. Scale: 0-100, 100 being the worse

Outcome measures

Outcome measures
Measure	AMZ001 Diclofenac Gel n=272 Participants AMZ001 diclofenac gel once daily	Placebo Gel n=276 Participants Placebo gel once daily
Change From Baseline in the WOMAC Pain Sub-score at Week 1, in the Target Knee	-17.25 Scores on a scale Interval -19.07 to -15.42	-15.55 Scores on a scale Interval -17.35 to -13.75

SECONDARY outcome

Timeframe: Baseline and Day 8

Change from baseline in daily pain at Day 8 using an 11-point Numeric Rating Scale (NRS) NRS: Numeric Rating Scale Scale: 0 -10, 10 being the worse

Outcome measures

Outcome measures
Measure	AMZ001 Diclofenac Gel n=272 Participants AMZ001 diclofenac gel once daily	Placebo Gel n=276 Participants Placebo gel once daily
Change From Baseline in Daily Pain at Day 8 Using an 11-point Numeric Rating Scale (NRS)	-1.66 Scores on a scale Interval -1.86 to -1.46	-1.42 Scores on a scale Interval -1.62 to -1.22

SECONDARY outcome

Timeframe: Baseline and Day 7

Change from baseline in daily pain at Day 7 using an 11-point Numeric Rating Scale (NRS) NRS scale: 0-10, 10 being worse

Outcome measures

Outcome measures
Measure	AMZ001 Diclofenac Gel n=272 Participants AMZ001 diclofenac gel once daily	Placebo Gel n=276 Participants Placebo gel once daily
Change From Baseline in Daily Pain at Day 7 Using an 11-point Numeric Rating Scale (NRS)	-1.58 Scores on a scale Interval -1.78 to -1.38	-1.40 Scores on a scale Interval -1.6 to -1.2

SECONDARY outcome

Timeframe: Baseline and Day 6

Change from baseline in daily pain at Day 6 using an 11-point Numeric Rating Scale (NRS) NRS: Numeric Rating Scale Scale: 0 -10, 10 being the worse

Outcome measures

Outcome measures
Measure	AMZ001 Diclofenac Gel n=272 Participants AMZ001 diclofenac gel once daily	Placebo Gel n=276 Participants Placebo gel once daily
Change From Baseline in Daily Pain at Day 6 Using an 11-point Numeric Rating Scale (NRS)	-1.58 Scores on a scale Interval -1.78 to -1.38	-1.41 Scores on a scale Interval -1.61 to -1.21

SECONDARY outcome

Timeframe: Baseline and Day 5

Change from baseline in daily pain at Day 5 using an 11-point Numeric Rating Scale (NRS) NRS: Numeric Rating Scale Scale: 0 -10, 10 being the worse

Outcome measures

Outcome measures
Measure	AMZ001 Diclofenac Gel n=272 Participants AMZ001 diclofenac gel once daily	Placebo Gel n=276 Participants Placebo gel once daily
Change From Baseline in Daily Pain at Day 5 Using an 11-point Numeric Rating Scale (NRS)	-1.51 Scores on a scale Interval -1.7 to -1.32	-1.33 Scores on a scale Interval -1.52 to -1.14

SECONDARY outcome

Timeframe: Baseline and Day 4

Change from baseline in daily pain at Day 4 using an 11-point Numeric Rating Scale (NRS) NRS: Numeric Rating Scale Scale: 0 -10, 10 being the worse

Outcome measures

Outcome measures
Measure	AMZ001 Diclofenac Gel n=272 Participants AMZ001 diclofenac gel once daily	Placebo Gel n=276 Participants Placebo gel once daily
Change From Baseline in Daily Pain at Day 4 Using an 11-point Numeric Rating Scale (NRS)	-1.41 Scores on a scale Interval -1.6 to -1.22	-1.17 Scores on a scale Interval -1.36 to -0.98

SECONDARY outcome

Timeframe: Baseline and Day 3

Change from baseline in daily pain at Day 3 using an 11-point Numeric Rating Scale (NRS) NRS: Numeric Rating Scale Scale: 0 -10, 10 being the worse

Outcome measures

Outcome measures
Measure	AMZ001 Diclofenac Gel n=272 Participants AMZ001 diclofenac gel once daily	Placebo Gel n=276 Participants Placebo gel once daily
Change From Baseline in Daily Pain at Day 3 Using an 11-point Numeric Rating Scale (NRS)	-1.19 Scores on a scale Interval -1.37 to -1.01	-1.18 Scores on a scale Interval -1.36 to -1.0

SECONDARY outcome

Timeframe: Baseline and Day 2

Change from baseline in daily pain at Day 2 using an 11-point Numeric Rating Scale (NRS) NRS: Numeric Rating Scale Scale: 0 -10, 10 being the worse

Outcome measures

Outcome measures
Measure	AMZ001 Diclofenac Gel n=272 Participants AMZ001 diclofenac gel once daily	Placebo Gel n=276 Participants Placebo gel once daily
Change From Baseline in Daily Pain at Day 2 Using an 11-point Numeric Rating Scale (NRS)	-1.07 Scores on a scale Interval -1.24 to -0.9	-1.01 Scores on a scale Interval -1.18 to -0.84

SECONDARY outcome

Timeframe: Baseline and Day 1

Change from baseline in daily pain at Day 1 using an 11-point Numeric Rating Scale (NRS) NRS: Numeric Rating Scale Scale: 0 -10, 10 being the worse

Outcome measures

Outcome measures
Measure	AMZ001 Diclofenac Gel n=272 Participants AMZ001 diclofenac gel once daily	Placebo Gel n=276 Participants Placebo gel once daily
Change From Baseline in Daily Pain at Day 1 Using an 11-point Numeric Rating Scale (NRS)	-0.86 Scores on a scale Interval -1.03 to -0.69	-0.80 Scores on a scale Interval -0.97 to -0.63

Adverse Events

AMZ001 Diclofenac Gel

Serious events: 4 serious events

Other events: 86 other events

Deaths: 0 deaths

Placebo Gel

Serious events: 1 serious events

Other events: 81 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	AMZ001 Diclofenac Gel n=272 participants at risk AMZ001 diclofenac gel once daily	Placebo Gel n=276 participants at risk Placebo gel once daily
Cardiac disorders Atrial fibrillation	0.37% 1/272 • from screening until end of follow-up, up to 84 days Treatment-Emergent Adverse Events (TEAEs) with Preferred Terms (PTs) are reported	0.00% 0/276 • from screening until end of follow-up, up to 84 days Treatment-Emergent Adverse Events (TEAEs) with Preferred Terms (PTs) are reported
Infections and infestations Bacterial abdominal infection	0.00% 0/272 • from screening until end of follow-up, up to 84 days Treatment-Emergent Adverse Events (TEAEs) with Preferred Terms (PTs) are reported	0.36% 1/276 • from screening until end of follow-up, up to 84 days Treatment-Emergent Adverse Events (TEAEs) with Preferred Terms (PTs) are reported
Injury, poisoning and procedural complications Chest injury	0.37% 1/272 • from screening until end of follow-up, up to 84 days Treatment-Emergent Adverse Events (TEAEs) with Preferred Terms (PTs) are reported	0.00% 0/276 • from screening until end of follow-up, up to 84 days Treatment-Emergent Adverse Events (TEAEs) with Preferred Terms (PTs) are reported
Investigations Ejection fraction decreased	0.37% 1/272 • from screening until end of follow-up, up to 84 days Treatment-Emergent Adverse Events (TEAEs) with Preferred Terms (PTs) are reported	0.00% 0/276 • from screening until end of follow-up, up to 84 days Treatment-Emergent Adverse Events (TEAEs) with Preferred Terms (PTs) are reported
Musculoskeletal and connective tissue disorders Back pain	0.37% 1/272 • from screening until end of follow-up, up to 84 days Treatment-Emergent Adverse Events (TEAEs) with Preferred Terms (PTs) are reported	0.00% 0/276 • from screening until end of follow-up, up to 84 days Treatment-Emergent Adverse Events (TEAEs) with Preferred Terms (PTs) are reported
Cardiac disorders Angina unstable	0.37% 1/272 • from screening until end of follow-up, up to 84 days Treatment-Emergent Adverse Events (TEAEs) with Preferred Terms (PTs) are reported	0.00% 0/276 • from screening until end of follow-up, up to 84 days Treatment-Emergent Adverse Events (TEAEs) with Preferred Terms (PTs) are reported

Other adverse events

Additional Information

Amzell disclosure

AMZELL BV

Phone: 0235560460

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Disclosure restriction: 7 years after completion of the Clinical Trial
Publication restrictions are in place

Restriction type: OTHER