Trial Outcomes & Findings for A Study of LY3972406 in Adult Participants With Moderate-to-Severe Plaque Psoriasis (NCT NCT06176768)

Last Updated: 2025-10-15

Results Overview

* The PASI is an investigator-administered, multi-item scale used to measure the severity of psoriasis based on lesion severity and the percent of body surface area (BSA) affected. * Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomical regions: head, trunk, upper limbs, lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). * The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region, and then multiplied by a constant corresponding to the region's percent BSA (0.1, 0.3, 0.2, and 0.4 for the above 4 regions, respectively). The resultant score for each anatomic region is then summed to yield the final PASI score. It ranges from 0 to 72, with higher scores reflecting greater disease severity. * The nonresponder imputation (NRI) method was used to handle missing data.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

33 participants

Primary outcome timeframe

Week 12

Results posted on

2025-10-15

Participant Flow

Participant milestones

Participant milestones
Measure	LY3972406 Participants received an oral dose of LY3972406 for 12 weeks.	Placebo Participants received an oral dose of placebo for 12 weeks.
Overall Study STARTED	16	17
Overall Study Received at Least 1 Dose of the Study Drug	16	17
Overall Study COMPLETED	3	4
Overall Study NOT COMPLETED	13	13

Reasons for withdrawal

Reasons for withdrawal
Measure	LY3972406 Participants received an oral dose of LY3972406 for 12 weeks.	Placebo Participants received an oral dose of placebo for 12 weeks.
Overall Study Adverse Event	1	0
Overall Study Assigned treatment by mistake	1	0
Overall Study Lost to Follow-up	0	3
Overall Study Physician Decision	1	0
Overall Study Protocol deviation	3	1
Overall Study Other	1	0
Overall Study Withdrawal by Subject	6	9

Baseline Characteristics

A Study of LY3972406 in Adult Participants With Moderate-to-Severe Plaque Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LY3972406 n=16 Participants Participants received an oral dose of LY3972406 for 12 weeks.	Placebo n=17 Participants Participants received an oral dose of placebo for 12 weeks.	Total n=33 Participants Total of all reporting groups
Age, Continuous	50.4 years STANDARD_DEVIATION 13.3 • n=5 Participants	50.2 years STANDARD_DEVIATION 13.5 • n=7 Participants	50.3 years STANDARD_DEVIATION 13.2 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	14 Participants n=7 Participants	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=5 Participants	10 Participants n=7 Participants	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	16 Participants n=5 Participants	17 Participants n=7 Participants	33 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 12

Population: All randomized participants who received at least one dose of the study drug.

Outcome measures

Outcome measures
Measure	LY3972406 n=16 Participants Participants received an oral dose of LY3972406 for 12 weeks.	Placebo n=17 Participants Participants received an oral dose of placebo for 12 weeks.
Percentage of Participants Achieving ≥75% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-75)	18.8 percentage of participants Interval 0.0 to 37.9	5.9 percentage of participants Interval 0.0 to 17.1

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: All randomized participants who received at least one dose of the study drug and had non-missing values for this outcome at week 12.

The percent BSA is the total percentage of psoriasis involvement on the participant's body surface, ranging from 0% (no involvement) to 100% (full involvement). It is measured using the handprint method, where 1% corresponds to the size of the participant's hand (including the palm, fingers, and thumb). The number of handprints fitting into the affected areas across the body is summed to estimate the total percentage of involvement.

Outcome measures

Outcome measures
Measure	LY3972406 n=11 Participants Participants received an oral dose of LY3972406 for 12 weeks.	Placebo n=10 Participants Participants received an oral dose of placebo for 12 weeks.
Change From Baseline in Percent Body Surface Area (BSA)	-7.26 percent BSA Standard Error 3.35	-0.48 percent BSA Standard Error 3.19

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: All randomized participants who received at least one dose of the study drug and had non-missing values for this outcome at week 12.

The DLQI is a validated, dermatology-specific, patient-reported outcomes 10-item questionnaire that evaluates participants health-related quality of life over the past week. The 10 questions are grouped into 6 domains, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories and corresponding scores are: * Very much = 3 * A lot = 2 * A little = 1 * Not at all = 0 * Not relevant = 0. The total score is calculated by summing all 10 question responses and has a range of 0 (no impact of skin disease on quality of life) to 30 (maximum impact on quality of life).

Outcome measures

Outcome measures
Measure	LY3972406 n=11 Participants Participants received an oral dose of LY3972406 for 12 weeks.	Placebo n=11 Participants Participants received an oral dose of placebo for 12 weeks.
Change From Baseline in Dermatology Life Quality Index (DLQI)	-6.71 score on a scale Standard Error 1.64	-4.35 score on a scale Standard Error 1.54

SECONDARY outcome

Timeframe: Predose at Week 12

Population: All randomized participants who received at least one dose of the study drug and had evaluable PK data.

Observed trough plasma concentration (Ctrough) of LY3972406.

Outcome measures

Outcome measures
Measure	LY3972406 n=8 Participants Participants received an oral dose of LY3972406 for 12 weeks.	Placebo Participants received an oral dose of placebo for 12 weeks.
Pharmacokinetics (PK): Observed Trough Plasma Concentration of LY3972406	158 Nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 155	—

Adverse Events

LY3972406

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	LY3972406 n=16 participants at risk Participants received an oral dose of LY3972406 for 12 weeks.	Placebo n=17 participants at risk Participants received an oral dose of placebo for 12 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.00% 0/16 • From baseline to the end of follow-up (up to Week 24) All randomized participants who received at least 1 dose of the study drug.	5.9% 1/17 • Number of events 1 • From baseline to the end of follow-up (up to Week 24) All randomized participants who received at least 1 dose of the study drug.

Other adverse events

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Measure	LY3972406 n=16 participants at risk Participants received an oral dose of LY3972406 for 12 weeks.	Placebo n=17 participants at risk Participants received an oral dose of placebo for 12 weeks.
Eye disorders Conjunctival haemorrhage	6.2% 1/16 • Number of events 1 • From baseline to the end of follow-up (up to Week 24) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/17 • From baseline to the end of follow-up (up to Week 24) All randomized participants who received at least 1 dose of the study drug.
Eye disorders Eczema eyelids	0.00% 0/16 • From baseline to the end of follow-up (up to Week 24) All randomized participants who received at least 1 dose of the study drug.	5.9% 1/17 • Number of events 1 • From baseline to the end of follow-up (up to Week 24) All randomized participants who received at least 1 dose of the study drug.
Gastrointestinal disorders Gastrooesophageal reflux disease	6.2% 1/16 • Number of events 1 • From baseline to the end of follow-up (up to Week 24) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/17 • From baseline to the end of follow-up (up to Week 24) All randomized participants who received at least 1 dose of the study drug.
General disorders Fatigue	6.2% 1/16 • Number of events 1 • From baseline to the end of follow-up (up to Week 24) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/17 • From baseline to the end of follow-up (up to Week 24) All randomized participants who received at least 1 dose of the study drug.
Infections and infestations Gastroenteritis	6.2% 1/16 • Number of events 1 • From baseline to the end of follow-up (up to Week 24) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/17 • From baseline to the end of follow-up (up to Week 24) All randomized participants who received at least 1 dose of the study drug.
Infections and infestations Nasopharyngitis	0.00% 0/16 • From baseline to the end of follow-up (up to Week 24) All randomized participants who received at least 1 dose of the study drug.	5.9% 1/17 • Number of events 1 • From baseline to the end of follow-up (up to Week 24) All randomized participants who received at least 1 dose of the study drug.
Infections and infestations Urinary tract infection	0.00% 0/16 • From baseline to the end of follow-up (up to Week 24) All randomized participants who received at least 1 dose of the study drug.	5.9% 1/17 • Number of events 1 • From baseline to the end of follow-up (up to Week 24) All randomized participants who received at least 1 dose of the study drug.
Injury, poisoning and procedural complications Contusion	6.2% 1/16 • Number of events 1 • From baseline to the end of follow-up (up to Week 24) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/17 • From baseline to the end of follow-up (up to Week 24) All randomized participants who received at least 1 dose of the study drug.
Injury, poisoning and procedural complications Fall	12.5% 2/16 • Number of events 2 • From baseline to the end of follow-up (up to Week 24) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/17 • From baseline to the end of follow-up (up to Week 24) All randomized participants who received at least 1 dose of the study drug.
Investigations Blood creatine phosphokinase increased	0.00% 0/16 • From baseline to the end of follow-up (up to Week 24) All randomized participants who received at least 1 dose of the study drug.	5.9% 1/17 • Number of events 1 • From baseline to the end of follow-up (up to Week 24) All randomized participants who received at least 1 dose of the study drug.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/16 • From baseline to the end of follow-up (up to Week 24) All randomized participants who received at least 1 dose of the study drug.	5.9% 1/17 • Number of events 1 • From baseline to the end of follow-up (up to Week 24) All randomized participants who received at least 1 dose of the study drug.
Metabolism and nutrition disorders Hypoglycaemia	6.2% 1/16 • Number of events 1 • From baseline to the end of follow-up (up to Week 24) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/17 • From baseline to the end of follow-up (up to Week 24) All randomized participants who received at least 1 dose of the study drug.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/16 • From baseline to the end of follow-up (up to Week 24) All randomized participants who received at least 1 dose of the study drug.	5.9% 1/17 • Number of events 1 • From baseline to the end of follow-up (up to Week 24) All randomized participants who received at least 1 dose of the study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/16 • From baseline to the end of follow-up (up to Week 24) All randomized participants who received at least 1 dose of the study drug.	5.9% 1/17 • Number of events 1 • From baseline to the end of follow-up (up to Week 24) All randomized participants who received at least 1 dose of the study drug.
Musculoskeletal and connective tissue disorders Psoriatic arthropathy	6.2% 1/16 • Number of events 1 • From baseline to the end of follow-up (up to Week 24) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/17 • From baseline to the end of follow-up (up to Week 24) All randomized participants who received at least 1 dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic renal cell carcinoma	0.00% 0/16 • From baseline to the end of follow-up (up to Week 24) All randomized participants who received at least 1 dose of the study drug.	5.9% 1/17 • Number of events 1 • From baseline to the end of follow-up (up to Week 24) All randomized participants who received at least 1 dose of the study drug.
Nervous system disorders Headache	12.5% 2/16 • Number of events 2 • From baseline to the end of follow-up (up to Week 24) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/17 • From baseline to the end of follow-up (up to Week 24) All randomized participants who received at least 1 dose of the study drug.
Psychiatric disorders Anxiety	6.2% 1/16 • Number of events 1 • From baseline to the end of follow-up (up to Week 24) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/17 • From baseline to the end of follow-up (up to Week 24) All randomized participants who received at least 1 dose of the study drug.
Psychiatric disorders Insomnia	6.2% 1/16 • Number of events 1 • From baseline to the end of follow-up (up to Week 24) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/17 • From baseline to the end of follow-up (up to Week 24) All randomized participants who received at least 1 dose of the study drug.
Renal and urinary disorders Haematuria	0.00% 0/16 • From baseline to the end of follow-up (up to Week 24) All randomized participants who received at least 1 dose of the study drug.	5.9% 1/17 • Number of events 1 • From baseline to the end of follow-up (up to Week 24) All randomized participants who received at least 1 dose of the study drug.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/16 • From baseline to the end of follow-up (up to Week 24) All randomized participants who received at least 1 dose of the study drug.	5.9% 1/17 • Number of events 1 • From baseline to the end of follow-up (up to Week 24) All randomized participants who received at least 1 dose of the study drug.
Skin and subcutaneous tissue disorders Erythema	6.2% 1/16 • Number of events 1 • From baseline to the end of follow-up (up to Week 24) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/17 • From baseline to the end of follow-up (up to Week 24) All randomized participants who received at least 1 dose of the study drug.
Skin and subcutaneous tissue disorders Nail ridging	6.2% 1/16 • Number of events 1 • From baseline to the end of follow-up (up to Week 24) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/17 • From baseline to the end of follow-up (up to Week 24) All randomized participants who received at least 1 dose of the study drug.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/16 • From baseline to the end of follow-up (up to Week 24) All randomized participants who received at least 1 dose of the study drug.	5.9% 1/17 • Number of events 1 • From baseline to the end of follow-up (up to Week 24) All randomized participants who received at least 1 dose of the study drug.
Skin and subcutaneous tissue disorders Psoriasis	6.2% 1/16 • Number of events 1 • From baseline to the end of follow-up (up to Week 24) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/17 • From baseline to the end of follow-up (up to Week 24) All randomized participants who received at least 1 dose of the study drug.
Skin and subcutaneous tissue disorders Urticaria	12.5% 2/16 • Number of events 2 • From baseline to the end of follow-up (up to Week 24) All randomized participants who received at least 1 dose of the study drug.	0.00% 0/17 • From baseline to the end of follow-up (up to Week 24) All randomized participants who received at least 1 dose of the study drug.
Vascular disorders Hypertension	0.00% 0/16 • From baseline to the end of follow-up (up to Week 24) All randomized participants who received at least 1 dose of the study drug.	5.9% 1/17 • Number of events 1 • From baseline to the end of follow-up (up to Week 24) All randomized participants who received at least 1 dose of the study drug.