This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Chronic Pain Master Protocol (CPMP): A Study of LY3526318 in Participants With Chronic Low Back Pain (NCT05086289), a randomized phase 2 study. The primary outcome is Change From Baseline for Average Pain Intensity as Measured by the Numeric Rating Scale (NRS) at Week 4.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05086289 |
| Phase | Phase 2 |
| Condition | Chronic Low-back Pain |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 159 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Eli Lilly and Company |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned participants with chronic low-back pain. The primary analysis population was participants who received at least one dose of study drug and had a non-missing Week 4 value. The registry record describes the analyzed group counts for the primary endpoint as 92 for LY3526318 and 50 for placebo.
Intervention
Participants assigned to LY3526318 received 250 mg orally once daily during the first 4 weeks. For the next 4 weeks, they switched to placebo once daily. Thus, the assigned treatment was not continued throughout the full treatment period.
Comparator
The comparator group received placebo orally once daily for the 8-week treatment period. The study was randomized, double-masked, and used a parallel-group design.
Primary question
The primary question was whether the groups differed in change from baseline in average pain intensity at Week 4, measured using the Numeric Rating Scale. The reported group contrast is a posterior mean difference of -0.38, with a 95% credible interval from -0.89 to 0.13. The estimate is more negative for the LY3526318 group, but the interval includes zero, so the reported result does not precisely distinguish a difference from no difference.
The registry record describes the study as a phase 2 trial within a chronic pain master protocol. The study’s stated purpose was to test LY3526318 for efficacy and safety in chronic low back pain. The primary endpoint addresses average pain over the past 24 hours at Week 4; it is not a summary of every pain or function measure collected in the trial. Other listed outcomes include disability, overall improvement, worst pain intensity, and pain measured with a Visual Analog Scale. The registry record does not report a separate primary question about those measures.
3. Trial Design
This was a randomized, double-masked, parallel-group phase 2 clinical trial of LY3526318 and placebo in participants with chronic low-back pain. The registry record reports enrollment of 159. The study is marked completed, with a start date of 2021-10-25 and a primary completion date of 2022-06-17. Those dates describe the registry record; they do not establish when every participant began or finished treatment.
The treatment schedules are important for understanding the contrast. Participants assigned to LY3526318 received 250 mg orally once daily for the first 4 weeks, then switched to placebo once daily for the next 4 weeks. Participants assigned to placebo received placebo once daily for the 8-week treatment period. The primary endpoint was measured at Week 4, while participants assigned to LY3526318 were still receiving LY3526318 according to the recorded schedule. The later treatment-period safety groups therefore describe a different exposure period from the first period.
Randomization is intended, in general, to create groups that are comparable on average at assignment; masking is intended to limit the influence of treatment knowledge on trial conduct or assessment. Those design features do not remove uncertainty from the outcome estimate or establish that all other aspects of conduct were free of bias. The registry record does not report the allocation ratio, the randomization procedure, the details of masking, or the method used to preserve masking after the switch.
The registry record identifies Eli Lilly and Company as sponsor and describes this trial as part of a chronic pain master protocol. Specific information about the relationship between this trial and other studies under that protocol, beyond the statement of membership, is not reported in the registry record. A sample-size justification and the trial’s original design assumptions are also not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | 250 Milligram (mg) LY3526318 | Placebo |
|---|---|---|
| STARTED | 105 | 54 |
| Received at Least One Dose of Study Drug (Safety Population Week 1-4) | 105 | 54 |
| Safety Population Week 5-8 | 92 | 50 |
| COMPLETED | 90 | 49 |
| NOT COMPLETED | 15 | 5 |
Reasons for not completing this period:
| Reason | 250 Milligram (mg) LY3526318 | Placebo |
|---|---|---|
| Adverse Event | 4 | 2 |
| Lost to Follow-up | 2 | 0 |
| Non-compliance with study drug | 2 | 1 |
| Physician Decision | 2 | 0 |
| Withdrawal by Subject | 5 | 2 |
Analysis population for the primary outcome, as defined in the registry: All enrolled participants who received at least one dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 4.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: All enrolled or randomized participants who received at least one dose of study drug.
| Characteristic | Unit | 250 mg LY3526318 | Placebo | Total |
|---|---|---|---|---|
| Participants analysed | 105 | 54 | 159 | |
| Age, Continuous | years | 54.00 (SD 13.20) | 54.30 (SD 13.74) | 54.10 (SD 13.34) |
| Sex: Female, Male: Female | Participants | 66 | 35 | 101 |
| Sex: Female, Male: Male | Participants | 39 | 19 | 58 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 25 | 15 | 40 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 80 | 39 | 119 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): Asian | Participants | 3 | 6 | 9 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 14 | 6 | 20 |
| Race (NIH/OMB): White | Participants | 84 | 42 | 126 |
| Race (NIH/OMB): More than one race | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 2 | 0 | 2 |
| Region of Enrollment: Puerto Rico | Participants | 2 | 2 | 4 |
| Region of Enrollment: United States | Participants | 103 | 52 | 155 |
| Average Pain Intensity as Measured by the Numeric Rating Scale (NRS) | score on a scale | 5.56 (SD 1.57) | 5.79 (SD 1.54) | 5.64 (SD 1.56) |
6. Primary Endpoint
The registry lists the primary outcome as Change From Baseline for Average Pain Intensity as Measured by the Numeric Rating Scale (NRS) at Week 4, measured over Baseline, Week 4.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | score on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint was change from baseline in average pain intensity at Week 4, measured with the Numeric Rating Scale. Participants rated their average pain over the past 24 hours on a scale from 0 to 10, where 0 means no pain and 10 means pain as bad as you can imagine. The endpoint is a continuous measure, and the registry record reports group means and a posterior mean difference.
Change from baseline focuses on how a participant’s score at follow-up differs from their own starting score, rather than relying only on the Week 4 score. In general, using a change measure can help describe improvement or worsening relative to baseline. For this scale, a more negative change represents a greater decrease in the reported score. This explains the direction of the reported estimates, but it does not by itself establish the clinical importance of a particular change.
Average pain intensity is one way to summarize a participant’s pain experience over a defined recall period. It is not interchangeable with worst pain, disability, or a global assessment of improvement. The registry lists those as other outcomes. Whether the NRS change corresponds to a meaningful improvement for participants, and what threshold would define such an improvement, is not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
For the primary endpoint, the reported posterior mean change from baseline was -1.28 in the LY3526318 group, with a 95% credible interval from -1.59 to -0.97. In the placebo group, the reported posterior mean change was -0.9, with a 95% credible interval from -1.32 to -0.48. Both group estimates are negative, indicating decreases in average pain scores relative to baseline. These within-group estimates are not, on their own, the randomized comparison.
The direct comparison is the posterior mean difference of -0.38 for LY3526318 relative to placebo, with a 95% credible interval from -0.89 to 0.13. The negative point estimate indicates that the estimated change was more negative in the LY3526318 group. However, the interval spans zero. The posted result therefore leaves uncertainty about whether the underlying difference is in that direction, near zero, or in the opposite direction. The interval also indicates uncertainty about the magnitude of any difference. A point estimate should not be read as a precise or definitive effect.
A credible interval is an interval produced from the Bayesian model and its assumptions. In general, it describes posterior uncertainty about the parameter conditional on the model and prior distribution. The registry record does not report the prior specification, so the interval’s dependence on prior choices cannot be assessed from the registry record. It also does not report a p-value for this primary comparison. The result should therefore be interpreted using the reported posterior estimate and interval, not by assigning a significance label based on an unreported test.
The primary endpoint was measured at Week 4, when the LY3526318 group’s recorded schedule still involved active study drug. The estimate does not directly answer whether any difference persisted after the switch to placebo. It also does not summarize the full treatment period, later outcomes, or the other listed measures. The outcome values describe group-level model estimates; they do not show how much participants varied individually or how many experienced a particular degree of change.
Although the record reports 159 enrolled, the primary population definition requires receipt of at least one dose and a non-missing Week 4 value. The analyzed group counts reported for the primary endpoint are 92 and 50. The record does not explain the difference between enrollment and the endpoint analysis counts. It is therefore not possible to determine from the registry record why some enrolled participants are not represented in those endpoint counts, or how their absence may affect interpretation.
Overall, the posted result is an uncertain estimate of the Week 4 contrast, not a conclusive statement about the treatment’s effect. The reported interval includes both a difference favoring the more negative estimate and values consistent with little or no difference. No threshold for clinical importance is reported, so statistical uncertainty and clinical meaning cannot be collapsed into a single judgment.
9. Statistical Methods Explained
What is a posterior mean?
The reported group estimates and contrast are posterior means from a Bayesian analysis. In general, a posterior distribution combines the information in the observed data with a prior distribution under a statistical model. A posterior mean is the mean of that resulting distribution for the quantity being estimated. It is a model-based summary, not simply the arithmetic average of the observed scores unless the analysis happens to make those quantities coincide. The registry record does not report the prior distribution or enough model detail to reconstruct the estimates.
What does the credible interval express?
The registry reports 95% credible intervals for the group changes and the between-group difference. In general, a credible interval is an interval of values that contains a stated share of the posterior probability for a parameter, conditional on the model and prior. It represents uncertainty in the estimated quantity; it is not a range of individual participant outcomes. The interval around the difference, -0.89 to 0.13, includes zero. That makes the direction and size of the contrast uncertain in the posted analysis. The interval alone does not establish a clinical threshold or identify which values would matter to participants.
Why use a repeated-measures model?
The primary description says that the estimates were derived using a Bayesian mixed model repeated measures analysis. In general, a repeated-measures model analyzes measurements collected over time while accounting for the fact that measurements from the same participant are related. A mixed model can represent patterns of change across time and can use observations at more than one visit in estimating the modeled outcome. This can be useful when trial measurements are collected repeatedly, rather than treating every observation as unrelated.
The registry record does not report the full model equation, covariance structure, covariates, prior choices, or detailed handling of missing observations. It is therefore not possible to assess those specific choices or reproduce the analysis from the registry description alone. The name of a model does not establish that every missing value was recovered or that missingness could not bias the result.
Why compare groups rather than only their changes?
In a randomized trial, the between-group contrast is the central estimate for comparing assigned groups. A decrease from baseline within one group does not establish that the group changed more than it would have under the comparator. Both reported group means are negative, but the comparison of interest is the posterior mean difference of -0.38, with its 95% credible interval. Keeping the contrast and its uncertainty in view avoids treating a within-group change as evidence of a treatment-specific effect.
The group-level changes and the between-group estimate are model-based summaries. Their intervals overlap, but visual overlap between separate group intervals is not a substitute for examining the interval for the direct contrast. The registry reports that direct contrast, so it is the most relevant summary for the primary randomized comparison.
How should the planning illustrations be read?
Planning illustrations based on an observed effect are not the trial’s own sample-size justification and are not observed power. The stated illustration assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The effect to detect is defined as a fraction of the observed effect. In general, such calculations show how sample-size requirements depend on an assumed effect and statistical design; they do not demonstrate that the completed trial had a particular probability of detecting a true effect. The registry record does not report the trial’s original sample-size justification, so the illustrations should not be mistaken for evidence about the design process.
The assumptions are also simplified representations of an analysis. A Bayesian repeated-measures model may use information differently from a normal-approximation planning calculation. The planning illustrations do not reproduce the sponsor’s model and do not resolve the uncertainty in the reported posterior estimate. They are useful only as conditional planning exercises under their stated assumptions.
10. Analyses Reported by the Sponsor
| Method | Estimate | 95% CI | P-value |
|---|---|---|---|
| not stated | Posterior Mean Difference -0.38 | -0.89 to 0.13 | not reported |
The registry record reports the primary result as a posterior mean difference of -0.38, with a 95% credible interval from -0.89 to 0.13, derived using a Bayesian mixed model repeated measures analysis. This is the sponsor’s posted model-based comparison and is the primary result to use when describing the registry analysis.
A separate unadjusted recalculation from summary statistics is not reported in the registry record. The posted group estimates and intervals do not by themselves supply all the information needed to reproduce a Bayesian repeated-measures analysis, including the model and prior details. A simple recalculation, if available, would answer a different and more limited question than the sponsor’s model-based analysis.
The registry record does not identify a discrepancy between the sponsor’s analysis and a recalculated result. The sponsor’s estimate should not be replaced by an invented or inferred contrast. Its interval includes zero, and its interpretation remains conditional on the analysis model and assumptions described in the record. Further details of the sponsor’s statistical specification are not reported in the registry record.
11. Multiplicity, Missing Data and Analysis Populations
The registry record lists 16 outcome measures and 16 analyses, and it identifies 15 secondary outcomes as posted. The secondary outcome list includes repeated descriptions of some measures, including the Roland Morris Disability Questionnaire, the Patient’s Global Impression of Change, and worst pain intensity. The record does not explain the relationship between the listed outcome measures, analyses, and repeated outcome descriptions.
When a trial examines multiple outcomes, time points, or analyses, the chance of observing an apparently notable result somewhere among them can increase. In general, multiplicity procedures are used to control or describe that issue, depending on the analysis goals. Whether an adjustment or a hierarchy of tests was used for the primary and secondary outcomes is not reported in the registry record. The primary endpoint can be described as the designated primary outcome, but the record does not support conclusions about how the broader set of analyses was handled statistically.
The primary analysis population is described as all enrolled participants who received at least one dose of study drug, with the overall number analyzed including participants with a non-missing Week 4 value. The primary endpoint counts are reported as 92 for LY3526318 and 50 for placebo. The registry record does not explain why these counts differ from the enrollment figure of 159, provide participant-level missingness by reason, or state how missing Week 4 values were handled in detail.
Repeated-measures modeling can use available measurements under its specified assumptions, in general, but that fact alone does not show how missing data were treated in this trial or whether assumptions about missingness were appropriate. The missing-data assumptions, any sensitivity analyses, and any imputation details are not reported in the registry record. The record also does not state whether the primary analysis followed an intention-to-treat principle or describe exclusions beyond the stated population definition.
These omissions matter because the estimated contrast applies to the analyzed data under the fitted model. Without further information, readers cannot assess how robust the primary result is to alternative missing-data assumptions or how the secondary analyses were protected against multiplicity.
12. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| 250 mg LY3526318 Week 1 to 4 | 2 | 105 | 1.9% |
| 250 mg LY3526318/Placebo Week 5 to 8 | 0 | 92 | 0.0% |
| Placebo Week 1 to 4 | 0 | 54 | 0.0% |
| Placebo Week 5 to 8 | 0 | 50 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| 250 mg LY3526318 Week 1 to 4 | 0 of 105 |
| 250 mg LY3526318/Placebo Week 5 to 8 | 0 of 92 |
| Placebo Week 1 to 4 | 0 of 54 |
| Placebo Week 5 to 8 | 0 of 50 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| 250 mg LY3526318 Week 1 to 4 | 36 of 105 |
| 250 mg LY3526318/Placebo Week 5 to 8 | 14 of 92 |
| Placebo Week 1 to 4 | 19 of 54 |
| Placebo Week 5 to 8 | 5 of 50 |
Most frequent serious adverse event terms
| Event term | Organ system | 250 mg LY3526318 Week 1 to 4 | 250 mg LY3526318/Placebo Week 5 to 8 | Placebo Week 1 to 4 | Placebo Week 5 to 8 |
|---|---|---|---|---|---|
| Hip fracture | Injury, poisoning and procedural complications | 1 of 105 | 0 of 92 | 0 of 54 | 0 of 50 |
| Suicidal ideation | Psychiatric disorders | 1 of 105 | 0 of 92 | 0 of 54 | 0 of 50 |
Most frequent non-serious adverse event terms
| Event term | Organ system | 250 mg LY3526318 Week 1 to 4 | 250 mg LY3526318/Placebo Week 5 to 8 | Placebo Week 1 to 4 | Placebo Week 5 to 8 |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | 3 of 105 | 1 of 92 | 2 of 54 | 1 of 50 |
| Nausea | Gastrointestinal disorders | 3 of 105 | 1 of 92 | 0 of 54 | 0 of 50 |
| COVID-19 | Infections and infestations | 2 of 105 | 1 of 92 | 1 of 54 | 0 of 50 |
| Anaemia | Blood and lymphatic system disorders | 1 of 105 | 0 of 92 | 1 of 54 | 1 of 50 |
| Constipation | Gastrointestinal disorders | 1 of 105 | 0 of 92 | 2 of 54 | 0 of 50 |
| Diarrhoea | Gastrointestinal disorders | 3 of 105 | 0 of 92 | 0 of 54 | 0 of 50 |
| Vomiting | Gastrointestinal disorders | 2 of 105 | 1 of 92 | 0 of 54 | 0 of 50 |
| Dizziness | Nervous system disorders | 3 of 105 | 0 of 92 | 0 of 54 | 0 of 50 |
| Upper respiratory tract infection | Infections and infestations | 1 of 105 | 1 of 92 | 1 of 54 | 0 of 50 |
| SARS-CoV-2 test positive | Investigations | 2 of 105 | 1 of 92 | 0 of 54 | 0 of 50 |
Serious events with the highest arm-level rate: hip fracture (1.0%), suicidal ideation (1.0%).
The safety record reports serious adverse events and other adverse events separately across treatment-period groups. For the first 4 weeks, the LY3526318 group lists 2 serious adverse events among 105 at risk and 36 other adverse events among 105 at risk. For the later period, the LY3526318/placebo group lists 0 serious adverse events among 92 at risk and 14 other adverse events among 92 at risk. The placebo group lists 0 serious adverse events among 54 at risk and 19 other adverse events among 54 at risk during the first 4 weeks, and 0 serious adverse events among 50 at risk and 5 other adverse events among 50 at risk during the next 4 weeks.
These are period-specific groups, not four independent randomized groups. The LY3526318 schedule switched to placebo after the first 4 weeks, and the later-period group label reflects that switch. The at-risk counts differ across periods; the registry record does not explain the reasons for those differences. The listed serious adverse event terms include hip fracture and suicidal ideation, each reported as 1.0%.
No deaths are reported in these safety groups. Event counts and terms describe what was recorded; they do not establish that a study drug caused an event or that an event was unrelated to treatment. The registry record does not provide enough detail to assess event timing, participant-level overlap, or comparative safety with precision.
13. What the Result Does, and Does Not, Mean
The primary result is an estimate of the difference between randomized groups in change from baseline in average pain intensity at Week 4. The posterior mean difference is -0.38, and its 95% credible interval ranges from -0.89 to 0.13. The estimate points toward a more negative change in the LY3526318 group, while the interval includes zero and leaves substantial uncertainty about the direction and magnitude of the contrast.
This result does not establish that the treatment produces a clinically meaningful improvement. The registry record does not state a threshold for a meaningful change, and the group-level estimate does not tell how individual participants experienced their pain. Nor does the result establish that there is no difference: an interval that includes zero is compatible with a range of possible contrasts under the reported model.
The endpoint is specific to average pain over the past 24 hours at Week 4. It does not answer whether any contrast continued during the later period, when the LY3526318 group switched to placebo. It also does not settle the results for disability, global improvement, worst pain, or the Visual Analog Scale measure. Those outcomes require their own estimates and uncertainty summaries.
The posted result depends on the Bayesian mixed model repeated measures analysis. The prior distribution, detailed model specification, and missing-data assumptions are not reported in the registry record. These details are relevant to understanding how the estimate was produced and how sensitive it might be to analysis choices.
The safety listings report adverse events by treatment period, but those counts alone do not establish causality or quantify comparative risk. Overall, the trial record documents a randomized comparison and an uncertain primary estimate; it does not support a definitive claim about benefit, lack of benefit, or the full safety profile.
14. Why This Trial Matters Statistically
This trial is statistically informative because it reports a direct randomized comparison rather than only describing change within each group. Its primary endpoint is a continuous measure, and the registry gives both group estimates and a model-based difference with an uncertainty interval. That combination helps distinguish the direction of the point estimate from the precision with which the comparison is known.
The result also illustrates why the contrast matters. Both groups had negative estimated changes from baseline, but within-group reductions do not isolate a treatment-specific difference. The posterior mean difference and its interval address the randomized comparison more directly. In this case, the interval includes zero, so the estimate remains uncertain despite a directional point estimate.
The treatment schedule makes timing central to interpretation. LY3526318 was given for the first 4 weeks and then replaced with placebo for the next 4 weeks, while the primary outcome was assessed at Week 4. The primary result therefore addresses the point specified in the schedule, not persistence of a difference during the later period. The safety listings likewise distinguish the first and later periods.
The record also gives an opportunity to distinguish trial results from planning illustrations. Calculations based on a fraction of the observed effect can illustrate planning assumptions, but they do not represent observed power or the original design justification. The registry record does not report that justification.
Finally, the record makes clear why reporting details matter. The analysis population is described, but reasons for the analyzed counts, missing-data handling, multiplicity procedures, and important model specifications are not reported. Those gaps limit independent assessment of robustness, even when the central estimate and interval are available.
15. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The primary result is reported for participants who received at least one dose and had a non-missing Week 4 value. Although the record reports enrollment of 159, it does not explain the difference between enrollment and the primary endpoint analysis counts of 92 and 50. Reasons for missing Week 4 data, exclusions, and any sensitivity analyses are not reported in the registry record. This prevents a fuller assessment of how missing outcomes may affect the estimate.
The registry describes a Bayesian mixed model repeated measures analysis but does not report the prior specification, detailed model structure, covariates, or covariance assumptions. These details could affect the estimated posterior distribution and are needed for an independent reproduction. The record also does not describe whether the primary analysis followed an intention-to-treat approach.
The treatment schedule changes after Week 4: participants initially assigned to LY3526318 switch to placebo for the next 4 weeks. The primary comparison is therefore tied to Week 4 and cannot by itself establish the pattern of outcomes under continued LY3526318 exposure or the persistence of any difference after the switch.
The interval around the primary contrast includes zero, and no threshold for clinical importance is reported. The registry record does not provide a basis for deciding whether the estimated magnitude is meaningful to participants. The secondary outcomes and other analyses add context, but the record does not report a multiplicity strategy. Their results should not be treated as though a prespecified adjustment or hierarchy were known.
Safety events are listed by treatment period, with changing at-risk counts. The record does not explain those count differences or provide enough information to infer causation from event counts. These limitations do not invalidate the posted estimates, but they constrain how much can be concluded from them.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Chronic Pain Master Protocol (CPMP): A Study of LY3526318 in Participants With Chronic Low Back Pain — NCT05086289.
- Registry record last updated 2023-10-05; status last verified 2023-10.
- Results first posted 2023-10-05.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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19. Record Summary
NCT05086289 is a completed randomized, double-masked, parallel-group phase 2 study of LY3526318 and placebo in participants with chronic low-back pain. The record reports enrollment of 159 and identifies Eli Lilly and Company as sponsor. LY3526318 was given at 250 mg once daily for the first 4 weeks, followed by placebo for the next 4 weeks; the comparator group received placebo for the 8-week treatment period.
The primary endpoint was change from baseline in average pain intensity on the Numeric Rating Scale at Week 4. The reported posterior mean difference was -0.38, with a 95% credible interval from -0.89 to 0.13. The interval includes zero, so the primary comparison is uncertain in direction and magnitude. The registry record also lists secondary outcomes and period-specific adverse-event counts. Detailed model and missing-data specifications, multiplicity procedures, and the original sample-size justification are not reported in the registry record.