Trial Outcomes & Findings for A Study of LY3434172, a PD-1 and PD-L1 Bispecific Antibody, in Advanced Cancer (NCT NCT03936959)

NCT ID: NCT03936959

Last Updated: 2025-01-15

Results Overview

A DLT is defined as adverse event/s of grade 3 or higher that occurs during the DLT observation period, which is Cycle 1 of each dose escalation cohort, and is clinically significant and definitely, probably, or possibly related to LY3434172, in the opinion of the investigator.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

10 participants

Primary outcome timeframe

Baseline through Cycle 1 (Up to 42 Day Cycle)

Results posted on

2025-01-15

Participant Flow

Completers are defined as participants who were observed for both primary and secondary outcomes.

Participant milestones

Participant milestones
Measure
3 Milligram (mg) - 10 mg LY3434172
3 mg LY3434172 administered intravenously (IV) on Day 1 Cycle 1 of 28-day cycle. 10 mg LY3434172 administered IV on Day 15 Cycle 1 of 28-day cycle. Participants continued to receive study treatment until they met a criterion for discontinuation.
30 mg LY3434172
30 mg LY3434172 administered IV on Day 1 and Day 15 of 28-day cycle. Participants continued to receive study treatment until they met a criterion for discontinuation.
100 mg LY3434172
100 mg LY3434172 administered IV on Day 1 and Day 15 of 28-day cycle. Participants continued to receive study treatment until they met a criterion for discontinuation.
Overall Study
STARTED
3
4
3
Overall Study
Received at Least One Dose of Study Drug
3
4
3
Overall Study
COMPLETED
3
4
3
Overall Study
NOT COMPLETED
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of LY3434172, a PD-1 and PD-L1 Bispecific Antibody, in Advanced Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
3 mg - 10 mg LY3434172
n=3 Participants
3 mg LY3434172 administered IV on Day 1 Cycle 1 of 28-day cycle. 10 mg LY3434172 administered IV on Day 15 Cycle 1 of 28-day cycle. Participants continued to receive study treatment until they met a criterion for discontinuation.
30 mg LY3434172
n=4 Participants
30 mg LY3434172 administered IV on Day 1 and Day 15 of 28-day cycle. Participants continued to receive study treatment until they met a criterion for discontinuation.
100 mg LY3434172
n=3 Participants
100 mg LY3434172 administered IV on Day 1 and Day 15 of 28-day cycle. Participants continued to receive study treatment until they met a criterion for discontinuation.
Total
n=10 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Age, Categorical
Between 18 and 65 years
1 Participants
n=5 Participants
3 Participants
n=7 Participants
1 Participants
n=5 Participants
5 Participants
n=4 Participants
Age, Categorical
>=65 years
2 Participants
n=5 Participants
1 Participants
n=7 Participants
2 Participants
n=5 Participants
5 Participants
n=4 Participants
Sex: Female, Male
Female
2 Participants
n=5 Participants
3 Participants
n=7 Participants
1 Participants
n=5 Participants
6 Participants
n=4 Participants
Sex: Female, Male
Male
1 Participants
n=5 Participants
1 Participants
n=7 Participants
2 Participants
n=5 Participants
4 Participants
n=4 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
2 Participants
n=5 Participants
2 Participants
n=4 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
0 Participants
n=4 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
1 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants
Race (NIH/OMB)
White
2 Participants
n=5 Participants
3 Participants
n=7 Participants
1 Participants
n=5 Participants
6 Participants
n=4 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants
Region of Enrollment
South Korea
0 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
1 Participants
n=4 Participants
Region of Enrollment
Belgium
1 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
3 Participants
n=4 Participants
Region of Enrollment
United States
2 Participants
n=5 Participants
3 Participants
n=7 Participants
0 Participants
n=5 Participants
5 Participants
n=4 Participants
Region of Enrollment
Australia
0 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
1 Participants
n=4 Participants

PRIMARY outcome

Timeframe: Baseline through Cycle 1 (Up to 42 Day Cycle)

Population: All participants who received any quantity of LY3434172, regardless of their eligibility for the study.

A DLT is defined as adverse event/s of grade 3 or higher that occurs during the DLT observation period, which is Cycle 1 of each dose escalation cohort, and is clinically significant and definitely, probably, or possibly related to LY3434172, in the opinion of the investigator.

Outcome measures

Outcome measures
Measure
3 mg - 10 mg LY3434172
n=3 Participants
3 mg LY3434172 administered IV on Day 1 Cycle 1 of 28-day cycle. 10 mg LY3434172 administered IV on Day 15 Cycle 1 of 28-day cycle. Participants continued to receive study treatment until they met a criterion for discontinuation.
30 mg LY3434172
n=4 Participants
30 mg LY3434172 administered IV on Day 1 and Day 15 of 28-day cycle. Participants continued to receive study treatment until they met a criterion for discontinuation.
100 mg LY3434172
n=3 Participants
100 mg LY3434172 administered IV on Day 1 and Day 15 of 28-day cycle. Participants continued to receive study treatment until they met a criterion for discontinuation.
Number of Participants With Dose Limiting Toxicities (DLTs)
0 Participants
0 Participants
0 Participants

SECONDARY outcome

Timeframe: PK: Cycle 1 Day 1 (C1D1): Predose; 1 hour(h); 3 h; 24 h; 72 h; 168 h post-infusion; Cycle 1 Day 15 (C1D15): Predose; 1 h; 3 h; 24 h; 72 h; 168 h post-infusion

Population: All participants who received at least one dose of LY3434172 and had evaluable PK data.

PK: Cmin of LY3434172

Outcome measures

Outcome measures
Measure
3 mg - 10 mg LY3434172
n=3 Participants
3 mg LY3434172 administered IV on Day 1 Cycle 1 of 28-day cycle. 10 mg LY3434172 administered IV on Day 15 Cycle 1 of 28-day cycle. Participants continued to receive study treatment until they met a criterion for discontinuation.
30 mg LY3434172
n=4 Participants
30 mg LY3434172 administered IV on Day 1 and Day 15 of 28-day cycle. Participants continued to receive study treatment until they met a criterion for discontinuation.
100 mg LY3434172
n=3 Participants
100 mg LY3434172 administered IV on Day 1 and Day 15 of 28-day cycle. Participants continued to receive study treatment until they met a criterion for discontinuation.
Pharmacokinetics (PK): Minimum Concentration (Cmin) of LY3434172
Cycle 1 Day 1
NA nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Cmin non calculable, value is less than lower limit of quantification (\<LLOQ).
775 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 107
4150 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 254
Pharmacokinetics (PK): Minimum Concentration (Cmin) of LY3434172
Cycle 1 Day 15
NA nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Cmin non calculable, value is \<LLOQ.
1017 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 63
5600 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 85

SECONDARY outcome

Timeframe: PK: Cycle 1 Day 1 (C1D1): Predose; 1 hour(h); 3 h; 24 h; 72 h; 168 h post-infusion; C1D15: Predose; 1 h; 3 h; 24 h; 72 h; 168 h post-infusion

Population: All participants who received at least one dose of LY3434172 and had evaluable PK data.

PK: Cmax of LY3434172

Outcome measures

Outcome measures
Measure
3 mg - 10 mg LY3434172
n=3 Participants
3 mg LY3434172 administered IV on Day 1 Cycle 1 of 28-day cycle. 10 mg LY3434172 administered IV on Day 15 Cycle 1 of 28-day cycle. Participants continued to receive study treatment until they met a criterion for discontinuation.
30 mg LY3434172
n=4 Participants
30 mg LY3434172 administered IV on Day 1 and Day 15 of 28-day cycle. Participants continued to receive study treatment until they met a criterion for discontinuation.
100 mg LY3434172
n=3 Participants
100 mg LY3434172 administered IV on Day 1 and Day 15 of 28-day cycle. Participants continued to receive study treatment until they met a criterion for discontinuation.
PK: Maximum Concentration (Cmax) of LY3434172
Cycle 1 Day 1
734 ng/mL
Geometric Coefficient of Variation 19.1
8250 ng/mL
Geometric Coefficient of Variation 17.7
22700 ng/mL
Geometric Coefficient of Variation 60.8
PK: Maximum Concentration (Cmax) of LY3434172
Cycle 1 Day 15
NA ng/mL
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation (CV) non calculable, individual PK parameters reported: 834 ng/mL; 2280 ng/mL
18600 ng/mL
Geometric Coefficient of Variation 52.9
43000 ng/mL
Geometric Coefficient of Variation 58.5

SECONDARY outcome

Timeframe: PK: Cycle 1 Day 1 (C1D1): Predose; 1 hour(h); 3 h; 24 h; 72 h; 168 h post-infusion; C1D15: Predose; 1 h; 3 h; 24 h; 72 h; 168 h post-infusion

Population: All participants who received at least one dose of LY3434172 and had evaluable PK data.

PK: AUC 0-tlast of LY3434172

Outcome measures

Outcome measures
Measure
3 mg - 10 mg LY3434172
n=3 Participants
3 mg LY3434172 administered IV on Day 1 Cycle 1 of 28-day cycle. 10 mg LY3434172 administered IV on Day 15 Cycle 1 of 28-day cycle. Participants continued to receive study treatment until they met a criterion for discontinuation.
30 mg LY3434172
n=4 Participants
30 mg LY3434172 administered IV on Day 1 and Day 15 of 28-day cycle. Participants continued to receive study treatment until they met a criterion for discontinuation.
100 mg LY3434172
n=3 Participants
100 mg LY3434172 administered IV on Day 1 and Day 15 of 28-day cycle. Participants continued to receive study treatment until they met a criterion for discontinuation.
PK: Area Under the Curve From Zero to Time to Last Measurable Concentration (AUC0-tlast) of LY3434172
C1D15
NA hour*nanogram per milliliter (hr*ng/mL)
Geometric Coefficient of Variation NA
Geometric Mean and CV non calculable, individual PK parameters reported: 9770 hr\*ng/mL; 29600 hr\*ng/mL.
559000 hour*nanogram per milliliter (hr*ng/mL)
Geometric Coefficient of Variation 239
3010000 hour*nanogram per milliliter (hr*ng/mL)
Geometric Coefficient of Variation 19.9
PK: Area Under the Curve From Zero to Time to Last Measurable Concentration (AUC0-tlast) of LY3434172
C1D1
7280 hour*nanogram per milliliter (hr*ng/mL)
Geometric Coefficient of Variation 51.0
584000 hour*nanogram per milliliter (hr*ng/mL)
Geometric Coefficient of Variation 31.5
1900000 hour*nanogram per milliliter (hr*ng/mL)
Geometric Coefficient of Variation 121

SECONDARY outcome

Timeframe: Baseline through Measured Progressive Disease (Up to 8.4 Months)

Population: All participants who received any quantity of LY3434172, regardless of their eligibility for the study.

ORR: Percentage of participants who have received any amount of study drug, have at least one postbaseline tumor image, and achieved a best overall response (BOR) of confirmed Complete Response (CR) is defined a disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis). Partial Response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Outcome measures
Measure
3 mg - 10 mg LY3434172
n=3 Participants
3 mg LY3434172 administered IV on Day 1 Cycle 1 of 28-day cycle. 10 mg LY3434172 administered IV on Day 15 Cycle 1 of 28-day cycle. Participants continued to receive study treatment until they met a criterion for discontinuation.
30 mg LY3434172
n=4 Participants
30 mg LY3434172 administered IV on Day 1 and Day 15 of 28-day cycle. Participants continued to receive study treatment until they met a criterion for discontinuation.
100 mg LY3434172
n=3 Participants
100 mg LY3434172 administered IV on Day 1 and Day 15 of 28-day cycle. Participants continued to receive study treatment until they met a criterion for discontinuation.
Objective Response Rate (ORR): Percentage of Participants With a Complete Response (CR) or Partial Response (PR)
Complete Response
0 Percentage of participants
0 Percentage of participants
0 Percentage of participants
Objective Response Rate (ORR): Percentage of Participants With a Complete Response (CR) or Partial Response (PR)
Partial Response
0 Percentage of participants
0 Percentage of participants
33.3 Percentage of participants

SECONDARY outcome

Timeframe: Date of CR or PR to Date of Objective Progression or Death Due to Any Cause (Up to 8.4 Months)

Population: All participants who received any quantity of LY3434172, regardless of their eligibility for the study.

DOR is defined only for responders (participants with a confirmed CR or PR). It is measured from the date of first evidence of a confirmed CR or PR to the date of the first observed radiographically documented progressive disease (PD), or the date of death due to any cause, whichever is earlier. If a responder is not known to have died or have objective progression as of the data inclusion cutoff date, DoR will be censored at the date of the last complete objective progression-free disease assessment.

Outcome measures

Outcome measures
Measure
3 mg - 10 mg LY3434172
3 mg LY3434172 administered IV on Day 1 Cycle 1 of 28-day cycle. 10 mg LY3434172 administered IV on Day 15 Cycle 1 of 28-day cycle. Participants continued to receive study treatment until they met a criterion for discontinuation.
30 mg LY3434172
30 mg LY3434172 administered IV on Day 1 and Day 15 of 28-day cycle. Participants continued to receive study treatment until they met a criterion for discontinuation.
100 mg LY3434172
n=1 Participants
100 mg LY3434172 administered IV on Day 1 and Day 15 of 28-day cycle. Participants continued to receive study treatment until they met a criterion for discontinuation.
Duration of Response (DOR)
NA Months
Median and 95% Confidence interval could not be calculated as there was only one participant. Individual value reported: 1.9 months, (57 days). DoR censored at the last available scan prior to data cut-off.

SECONDARY outcome

Timeframe: Baseline to Date of CR or PR (Up to 8.4 Months)

Population: All participants who received any quantity of LY3434172, regardless of their eligibility for the study.

TTR is defined as the time from the date of first study treatment until the first evidence of confirmed CR or PR.

Outcome measures

Outcome measures
Measure
3 mg - 10 mg LY3434172
3 mg LY3434172 administered IV on Day 1 Cycle 1 of 28-day cycle. 10 mg LY3434172 administered IV on Day 15 Cycle 1 of 28-day cycle. Participants continued to receive study treatment until they met a criterion for discontinuation.
30 mg LY3434172
30 mg LY3434172 administered IV on Day 1 and Day 15 of 28-day cycle. Participants continued to receive study treatment until they met a criterion for discontinuation.
100 mg LY3434172
n=1 Participants
100 mg LY3434172 administered IV on Day 1 and Day 15 of 28-day cycle. Participants continued to receive study treatment until they met a criterion for discontinuation.
Time to Response (TTR)
NA Months
Median and 95% Confidence interval could not be calculated as there was only one participant. Individual value reported: 1.7 months (52 days).

SECONDARY outcome

Timeframe: Baseline through Measured Progressive Disease (Up to 8.4 Months)

Population: All participants who received any quantity of LY3434172, regardless of their eligibility for the study.

Disease control rate is defined as the number of participants with SD, confirmed PR, or confirmed CR (CR+PR+SD) divided by the number of enrolled participants who have received any quantity of study treatment.

Outcome measures

Outcome measures
Measure
3 mg - 10 mg LY3434172
n=3 Participants
3 mg LY3434172 administered IV on Day 1 Cycle 1 of 28-day cycle. 10 mg LY3434172 administered IV on Day 15 Cycle 1 of 28-day cycle. Participants continued to receive study treatment until they met a criterion for discontinuation.
30 mg LY3434172
n=4 Participants
30 mg LY3434172 administered IV on Day 1 and Day 15 of 28-day cycle. Participants continued to receive study treatment until they met a criterion for discontinuation.
100 mg LY3434172
n=3 Participants
100 mg LY3434172 administered IV on Day 1 and Day 15 of 28-day cycle. Participants continued to receive study treatment until they met a criterion for discontinuation.
Disease Control Rate (DCR): Percentage of Participants Who Exhibit Stable Disease (SD), CR or PR
66.7 percentage of participants
25.0 percentage of participants
66.7 percentage of participants

Adverse Events

3 mg -10 mg LY3434172

Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths

30 mg LY3434172

Serious events: 1 serious events
Other events: 4 other events
Deaths: 1 deaths

100 mg LY3434172

Serious events: 1 serious events
Other events: 3 other events
Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure
3 mg -10 mg LY3434172
n=3 participants at risk
3 mg LY3434172 administered IV on Day 1 Cycle 1 of 28-day cycle. 10 mg LY3434172 administered IV on Day 15 Cycle 1 of 28-day cycle. Participants continued to receive study treatment until they met a criterion for discontinuation.
30 mg LY3434172
n=4 participants at risk
30 mg LY3434172 administered IV on Day 1 and Day 15 of 28-day cycle. Participants continued to receive study treatment until they met a criterion for discontinuation
100 mg LY3434172
n=3 participants at risk
100 mg LY3434172 administered IV on Day 1 and Day 15 of 28-day cycle. Participants continued to receive study treatment until they met a criterion for discontinuation.
Gastrointestinal disorders
Small intestinal obstruction
0.00%
0/3 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
25.0%
1/4 • Number of events 1 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
0.00%
0/3 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
33.3%
1/3 • Number of events 1 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
0.00%
0/4 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
0.00%
0/3 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
33.3%
1/3 • Number of events 1 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
0.00%
0/4 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
0.00%
0/3 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
Respiratory, thoracic and mediastinal disorders
Pneumothorax
0.00%
0/3 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
0.00%
0/4 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
33.3%
1/3 • Number of events 1 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.

Other adverse events

Other adverse events
Measure
3 mg -10 mg LY3434172
n=3 participants at risk
3 mg LY3434172 administered IV on Day 1 Cycle 1 of 28-day cycle. 10 mg LY3434172 administered IV on Day 15 Cycle 1 of 28-day cycle. Participants continued to receive study treatment until they met a criterion for discontinuation.
30 mg LY3434172
n=4 participants at risk
30 mg LY3434172 administered IV on Day 1 and Day 15 of 28-day cycle. Participants continued to receive study treatment until they met a criterion for discontinuation
100 mg LY3434172
n=3 participants at risk
100 mg LY3434172 administered IV on Day 1 and Day 15 of 28-day cycle. Participants continued to receive study treatment until they met a criterion for discontinuation.
Cardiac disorders
Palpitations
0.00%
0/3 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
0.00%
0/4 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
33.3%
1/3 • Number of events 1 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
Gastrointestinal disorders
Abdominal pain
33.3%
1/3 • Number of events 1 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
25.0%
1/4 • Number of events 1 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
0.00%
0/3 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
Gastrointestinal disorders
Constipation
0.00%
0/3 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
50.0%
2/4 • Number of events 2 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
0.00%
0/3 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
Gastrointestinal disorders
Diarrhoea
0.00%
0/3 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
0.00%
0/4 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
33.3%
1/3 • Number of events 1 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
Gastrointestinal disorders
Flatulence
0.00%
0/3 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
25.0%
1/4 • Number of events 1 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
0.00%
0/3 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
Gastrointestinal disorders
Nausea
0.00%
0/3 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
75.0%
3/4 • Number of events 7 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
33.3%
1/3 • Number of events 1 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
Gastrointestinal disorders
Small intestinal obstruction
0.00%
0/3 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
25.0%
1/4 • Number of events 1 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
0.00%
0/3 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
Gastrointestinal disorders
Vomiting
0.00%
0/3 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
50.0%
2/4 • Number of events 5 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
0.00%
0/3 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
General disorders
Fatigue
0.00%
0/3 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
50.0%
2/4 • Number of events 2 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
66.7%
2/3 • Number of events 2 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
General disorders
Gait disturbance
0.00%
0/3 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
25.0%
1/4 • Number of events 1 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
0.00%
0/3 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
General disorders
Oedema peripheral
66.7%
2/3 • Number of events 2 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
50.0%
2/4 • Number of events 3 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
0.00%
0/3 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
General disorders
Pyrexia
0.00%
0/3 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
25.0%
1/4 • Number of events 1 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
33.3%
1/3 • Number of events 1 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
Infections and infestations
Cellulitis
33.3%
1/3 • Number of events 1 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
0.00%
0/4 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
0.00%
0/3 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
Infections and infestations
Gastrointestinal infection
0.00%
0/3 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
0.00%
0/4 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
33.3%
1/3 • Number of events 1 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
Infections and infestations
Upper respiratory tract infection
33.3%
1/3 • Number of events 1 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
0.00%
0/4 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
0.00%
0/3 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
Investigations
Lymphocyte count decreased
33.3%
1/3 • Number of events 2 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
0.00%
0/4 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
0.00%
0/3 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
Investigations
Weight decreased
0.00%
0/3 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
25.0%
1/4 • Number of events 2 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
0.00%
0/3 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
Metabolism and nutrition disorders
Decreased appetite
33.3%
1/3 • Number of events 1 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
25.0%
1/4 • Number of events 1 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
33.3%
1/3 • Number of events 1 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
Metabolism and nutrition disorders
Dehydration
0.00%
0/3 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
25.0%
1/4 • Number of events 1 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
0.00%
0/3 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
Metabolism and nutrition disorders
Hypercalcaemia
33.3%
1/3 • Number of events 3 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
0.00%
0/4 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
0.00%
0/3 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
Metabolism and nutrition disorders
Hyperglycaemia
0.00%
0/3 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
25.0%
1/4 • Number of events 1 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
33.3%
1/3 • Number of events 1 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
Metabolism and nutrition disorders
Hypokalaemia
0.00%
0/3 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
25.0%
1/4 • Number of events 1 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
0.00%
0/3 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
Metabolism and nutrition disorders
Hyponatraemia
33.3%
1/3 • Number of events 1 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
0.00%
0/4 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
0.00%
0/3 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
0.00%
0/3 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
0.00%
0/4 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
33.3%
1/3 • Number of events 1 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
Musculoskeletal and connective tissue disorders
Myalgia
0.00%
0/3 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
25.0%
1/4 • Number of events 2 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
0.00%
0/3 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
0.00%
0/3 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
0.00%
0/4 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
33.3%
1/3 • Number of events 1 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
Nervous system disorders
Dysgeusia
33.3%
1/3 • Number of events 1 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
0.00%
0/4 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
0.00%
0/3 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
Nervous system disorders
Dyskinesia
0.00%
0/3 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
0.00%
0/4 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
33.3%
1/3 • Number of events 1 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
Nervous system disorders
Headache
0.00%
0/3 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
25.0%
1/4 • Number of events 1 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
0.00%
0/3 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
Nervous system disorders
Neuropathy peripheral
33.3%
1/3 • Number of events 1 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
0.00%
0/4 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
0.00%
0/3 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
Respiratory, thoracic and mediastinal disorders
Cough
33.3%
1/3 • Number of events 1 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
0.00%
0/4 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
33.3%
1/3 • Number of events 1 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
0.00%
0/3 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
25.0%
1/4 • Number of events 1 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
0.00%
0/3 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
Vascular disorders
Deep vein thrombosis
0.00%
0/3 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
25.0%
1/4 • Number of events 1 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.
0.00%
0/3 • Baseline Up to 16.7 Months
All participants who received any quantity of LY3434172, regardless of their eligibility for the study.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: GT60