A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities (NCT05869903), a randomized phase 3 study. The primary outcome is Percent Change From Baseline in Body Weight (Primary Treatment Period).

2. Clinical Question

3. Trial Design

This is a Phase 3, randomized, double-blind, parallel-group study comparing three orforglipron doses with placebo. The registry identifies the sponsor as Eli Lilly and Company. The study began on 2023-06-05, has a primary completion date of 2025-07-25, and is listed as active, not recruiting. These record details describe the study’s registration status and dates, not necessarily the timing of every analysis.

During the primary treatment period, participants received daily oral study treatment from Week 0 through Week 72. The 6 mg group started at 1 mg and escalated every 4 weeks to 6 mg at week 8; the 12 mg group started at 1 mg and escalated to 12 mg at week 12; and the 36 mg group started at 1 mg and escalated to 36 mg at week 20. The stated maintenance period followed the relevant target dose. The placebo group received matching placebo over the same primary treatment period.

The registry describes a main phase and an extension phase. Participants with prediabetes were to continue in the extension for another 2 years. The primary endpoint and the listed secondary outcomes use baseline and Week 72 assessments. The registry record does not report a separate extension result in the posted outcomes. The original allocation ratio, details of stratified randomization, and the trial’s sample-size justification are 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.

Before assignment: This study was designed with two treatment periods. The Primary Treatment Period (Week 0 to Week 72) enrolled participants with normoglycemia or prediabetes at randomization. The Additional Treatment Period (Week 72 to Week 176) is limited to the subset of participants who had prediabetes at randomization and completed the Primary Treatment Period.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: All randomized participants who had evaluable data for this specific outcome were included. Data points obtained during the treatment period, defined as at or after baseline up to the earliest date of discontinuation of study drug or initiation of prohibited weight management treatments, were included in the analysis.

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 randomized participants.

6. Primary Endpoint

The registry lists the primary outcome as Percent Change From Baseline in Body Weight (Primary Treatment Period), measured over Baseline, Week 72.

The primary endpoint is percent change from baseline in body weight, assessed at Week 72. A percent-change measure expresses the change relative to a participant’s baseline weight rather than as an absolute weight-unit change. The posted group results are least-squares means, which are model-based estimates, with standard errors. The comparisons report the estimated difference between each dose group and placebo.

General statistical context: Body weight is a continuous measure, so the endpoint retains information about the size of individual measurements rather than reducing the outcome to a category such as reaching or not reaching a threshold. A relative-change scale can make changes easier to compare across participants whose starting weights differ. That is a general reason such endpoints may be used; the registry record does not state the sponsor’s specific rationale for selecting this endpoint.

The endpoint is limited to the primary treatment period. It does not, by itself, describe weight change after treatment ends, long-term maintenance, or results in the extension phase. The registry’s outcome description says the analysis included randomized participants with evaluable data for this specific outcome and used data obtained during treatment up to the earliest of study-drug discontinuation or initiation of prohibited weight-management treatments. Further details about missing measurements are not reported in the registry record.

7. Results Posted in the Registry

• 6 mg Orforglipron: mean -7.82 versus -0.87 on control; difference -6.95 (95% CI -7.71 to -6.19), standardized effect d = -0.89; z-test p = <0.001.
• 12 mg Orforglipron: mean -9.27 versus -0.87 on control; difference -8.40 (95% CI -9.22 to -7.58), standardized effect d = -1.02; z-test p = <0.001.
• 36 mg Orforglipron: mean -12.35 versus -0.87 on control; difference -11.48 (95% CI -12.34 to -10.62), standardized effect d = -1.33; z-test p = <0.001.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Change From Baseline in Waist Circumference (Primary Treatment Period)

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard errors.
• Result:
  • 6 mg Orforglipron: mean -7.54 versus -2.09 on control; difference -5.45 (95% CI -6.24 to -4.66), standardized effect d = -0.67; z-test p = <0.001.
  • 12 mg Orforglipron: mean -9.00 versus -2.09 on control; difference -6.91 (95% CI -7.72 to -6.10), standardized effect d = -0.84; z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for 6 mg Orforglipron than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for 12 mg Orforglipron than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Change From Baseline in Systolic Blood Pressure (SBP) (Pooled Doses of Orforglipron 6 mg, 12 mg and 36 mg) - Primary Treatment Period

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard errors.
• Result:
  • Pooled 6 mg/12 mg/36 mg Orforglipron: mean -6.14 versus -0.78 on control; difference -5.36 (95% CI -6.33 to -4.39), standardized effect d = -0.41; z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for Pooled 6 mg/12 mg/36 mg Orforglipron than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Change From Baseline in HbA1c (Primary Treatment Period)

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard errors.
• Result:
  • 6 mg Orforglipron: mean -0.31 versus -0.03 on control; difference -0.28 (95% CI -0.31 to -0.25), standardized effect d = -0.96; z-test p = <0.001.
  • 12 mg Orforglipron: mean -0.31 versus -0.03 on control; difference -0.28 (95% CI -0.31 to -0.25), standardized effect d = -0.96; z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for 6 mg Orforglipron than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for 12 mg Orforglipron than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

The registry lists secondary outcomes spanning body measurements, blood pressure, lipids, glucose regulation, and insulin. Numerical results are posted for waist circumference, pooled-dose systolic blood pressure, and HbA1c. Across these posted outcomes, the estimated changes are generally more negative in the active-treatment results than in placebo. This broad pattern is directionally consistent with the primary body-weight result, but the measures describe different aspects of health and should not be conflated.

For waist circumference, results are posted for 6 mg and 12 mg; the registry record does not report a posted 36 mg result for this endpoint. The systolic blood pressure result is reported for pooled orforglipron doses rather than separately by dose. HbA1c results are posted for 6 mg and 12 mg, while a 36 mg comparison is not reported in the registry record. Numerical results for the other listed secondary outcomes are not reported in the registry record.

The secondary results carry less inferential weight than the primary endpoint because they are additional outcomes and the record does not state whether a multiplicity adjustment or formal testing hierarchy was used. Without such information, nominal p-values across multiple outcomes can overstate the strength of evidence if interpreted as a collection of confirmatory tests. The secondary outcomes can add context to the primary result, but they should be interpreted as supportive or exploratory unless the protocol’s prespecified inferential framework is known.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Change From Baseline in Waist Circumference (Primary Treatment Period)
• Change From Baseline in Systolic Blood Pressure (SBP) (Pooled Doses of Orforglipron 6 mg, 12 mg and 36 mg) - Primary Treatment Period
• Percent Change From Baseline in Non-High Density Lipoprotein (Non-HDL) Cholesterol (Pooled Doses of Orforglipron 6 mg, 12 mg and 36 mg) - Primary Treatment Period
• Percent Change From Baseline in Triglycerides (Pooled Doses of Orforglipron 6 mg, 12 mg and 36 mg) - Primary Treatment Period
• Change From Baseline in HbA1c (Primary Treatment Period)
• Change From Baseline in Fasting Serum Glucose (FSG) (Primary Treatment Period)
• Percent Change From Baseline in Fasting Insulin (Primary Treatment Period)
• Change From Baseline in Diastolic Blood Pressure (DBP) (Pooled Doses of Orforglipron 6 mg, 12 mg and 36 mg) - Primary Treatment Period

9. Statistical Interpretation

10. Statistical Methods Explained

The primary analysis is described as a mixed-model repeated-measures analysis, or MMRM, of post-baseline measurements. It reports least-squares means and net least-squares mean differences. The registry calls these least-squares means model-based estimates of the unconditional average treatment effect. They are adjusted estimates from the specified model, rather than simple arithmetic averages of the posted group measurements.

What does the model account for?

The model description includes geographic region, baseline by time by treatment, and strata by time by treatment. Strata were defined by the joint levels of sex and prediabetes status. The registry also states that the variance-covariance structure for change from baseline was unstructured. That structure allows the model to estimate relationships among repeated measurements without imposing a simpler fixed pattern of correlations.

General statistical context: Repeated measurements from the same participant are usually correlated. An MMRM models that within-participant relationship while estimating changes over time and contrasts between treatment groups. This can use measurements at multiple post-baseline times rather than reducing every participant’s record to a single change score. Model-based estimates depend on the model specification and on assumptions about the observed data; the registry description does not provide every implementation detail needed to evaluate those assumptions.

What does a least-squares mean difference represent?

The difference is the model’s estimated contrast between a dose group and placebo on the endpoint scale. For body weight, the scale is percent change from baseline. A negative contrast means the estimated change is more negative in the dose group than in placebo. Its confidence interval gives a measure of statistical precision around the estimate, while the p-value summarizes evidence against the null hypothesis used for that comparison. A p-value does not indicate the probability that the null hypothesis is true, nor does it measure the clinical importance of the estimate.

How should the recalculations be distinguished?

The additional unadjusted calculations use the posted group estimates and standard errors to approximate mean differences, confidence intervals, and planning illustrations. They are not a replacement for the sponsor’s MMRM analysis. The pooled standard deviations are approximate because they are derived from standard errors and group sizes, rather than from participant-level variability. The recalculated comparisons are unadjusted and should not be interpreted as the trial’s prespecified inferential analysis.

For the primary endpoint, the recalculated contrasts are -6.95, -8.4, and -11.48 for 6 mg, 12 mg, and 36 mg, respectively. Their intervals are close to the registry’s reported intervals, with slight differences in rounding. The discrepancy indicator is false. The sponsor’s reported mixed-model estimates remain the appropriate reference for the trial’s own analysis, particularly because they come from the stated model and include the registry’s analysis framework.

What is not specified?

The registry record does not report the original sample-size assumptions, a detailed missing-data strategy, the exact hypothesis-testing hierarchy, or whether and how multiplicity was controlled. It also does not report all model diagnostics or sensitivity analyses. Those absences limit assessment of the full analysis plan. General statistical interpretation should therefore distinguish the reported model results from any unadjusted recalculation or planning illustration.

11. Confidence Intervals and Precision

The sponsor’s primary comparisons have 95% confidence intervals. For 6 mg, the estimated net difference is -6.95, with an interval from -7.71 to -6.18. For 12 mg, it is -8.40, with an interval from -9.22 to -7.58. For 36 mg, it is -11.48, with an interval from -12.35 to -10.61. Each interval is on the percent-change scale and compares the dose group with placebo.

General statistical context: A confidence interval expresses the precision of an estimate under the analysis model and its assumptions. A narrower interval indicates greater precision than a wider interval on the same scale; it does not guarantee that an estimate is free of bias or that the model assumptions are correct. The intervals exclude zero, consistent with the reported p-values of <.001 for the respective comparisons, but that fact does not answer questions about clinical importance or long-term outcomes.

The recalculated intervals are approximate and unadjusted, whereas the registry’s intervals come from the mixed-model analysis. Small differences between their endpoints reflect the different calculation basis and rounding. For interpretation of the trial result, the sponsor’s reported model-based estimates and intervals are the primary values. No confidence intervals for the separate dose-versus-dose contrasts are reported in the registry record.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning illustrations give the number of participants per arm for the stated power levels; they do not give total trial enrollment. The listed assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is set as a stated fraction of the observed effect. The original trial’s own design assumptions and sample-size justification are not reported in the registry record.

The 80% power column means the illustrative number of participants per arm under which the calculation would have an 80% chance of detecting the chosen effect at the stated significance level, if the assumptions hold. The 90% power column describes the corresponding target for a 90% chance. These are planning concepts, not guarantees for a future study. The table’s rows distinguish planning for 100%, 75%, or 50% of the observed effect. Smaller effects need more participants to detect than larger effects, all else equal.

These numbers are based on the observed results and are not observed power. They are not the number enrolled in this trial, and they should not be read as evidence that the trial was adequately or inadequately sized under its original protocol. The illustration also simplifies the analysis by using equal allocation and a normal approximation rather than reproducing the registry’s MMRM analysis and its design decisions.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = -6.950; pooled standard deviation σ = 7.834.
2. n = 2 × (1.96 + 0.842)² × 7.834² / -6.950² = 19.9, rounded up to 20 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- -6.95                      # observed difference in means
sigma <- 7.83420658838284                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(5869903)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 20 (80% power), 27 (90% power)
 75% of observed effect: n per arm = 36 (80% power), 48 (90% power)
 50% of observed effect: n per arm = 80 (80% power), 107 (90% power)
power.t.test: 21 
Simulated power at n = 20 per arm: 0.780 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Analyses Reported by the Sponsor

The registry’s own primary analyses use mixed models and report net least-squares mean differences with 95% confidence intervals and p-values. The unadjusted recalculations are a separate statistical check based on posted group estimates and standard errors. For the primary endpoint, the recalculated estimates are close to the sponsor’s reported values, with modest differences in some interval endpoints attributable to the calculation basis and rounding.

The recalculated values are not adjusted for the model terms described in the registry and should not replace the reported analysis. The registry’s discrepancy indicator is false, so there is no flagged mismatch between the posted results and the recalculation. The sponsor’s mixed-model results provide the main basis for describing the trial’s primary comparisons. The recalculated figures are useful as a rough cross-check and as inputs to planning illustrations, not as a second independent trial analysis.

15. Multiplicity, Missing Data and Analysis Populations

The registry lists 12 outcome measures and 21 analyses, including multiple treatment comparisons and several secondary outcomes. Testing multiple hypotheses increases the chance that at least one result will appear statistically notable by chance if each test is considered separately. General statistical context: Multiplicity procedures can control that risk by adjusting significance thresholds or by defining an ordered testing strategy. The registry record does not report whether a multiplicity adjustment was used, how the primary and secondary hypotheses were ordered, or which comparisons were designated confirmatory beyond the analyses shown.

The primary endpoint population is described as randomized participants with evaluable data for the specific outcome. The outcome description also says that data obtained during the treatment period were included, with the period ending at the earliest date of study-drug discontinuation or initiation of prohibited weight-management treatments. This indicates that the stated primary analysis uses a defined on-treatment data window. The record does not give enough detail to determine how measurements after discontinuation, prohibited treatment, or other missing observations were handled statistically.

The registry’s MMRM model description identifies model terms and an unstructured variance-covariance structure, but the missing-data assumptions and sensitivity analyses are not reported in the registry record. Those details matter because missing outcomes can affect the estimate if the people with observed measurements differ systematically from those without them. The record also does not report the original sample-size rationale or whether interim analyses were planned or conducted. These omissions do not change the posted estimates, but they limit independent assessment of the full prespecified statistical plan.

16. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: ureterolithiasis (0.4%), cholecystitis acute (0.4%), testicular germ cell tumour mixed (0.4%), acute myocardial infarction (0.3%), nephrolithiasis (0.3%).

The posted safety figures count participants with serious adverse events among those at risk in each group. The registry reports 46 serious adverse events among 948 at risk in placebo, 40 among 723 at risk with 6 mg, 39 among 724 at risk with 12 mg, and 28 among 728 at risk with 36 mg. These are group counts, not rates recalculated for time at risk. The registry record does not provide a definition of serious adverse events in the data.

Deaths are listed as 1 in placebo, 1 in the 6 mg group, 1 in the 12 mg group, and 0 in the 36 mg group. The listed serious-event terms and percentages include ureterolithiasis, acute cholecystitis, mixed testicular germ cell tumour, acute myocardial infarction, nephrolithiasis, and obstructive pancreatitis. These selected terms do not constitute a complete safety profile. Counts alone do not establish whether an event was caused by study treatment, and the registry record does not report a causal assessment in these figures. Safety interpretation also requires attention to event definitions, follow-up, exposure, and context, some of which are not reported in the registry record.

17. What the Result Does, and Does Not, Mean

The posted primary results indicate that, at Week 72, the model-based mean percent change in body weight was more negative in each orforglipron dose group than in the placebo group. The registry’s mixed-model contrasts are negative, their reported 95% confidence intervals exclude zero, and the corresponding p-values are <.001. These findings describe the registered primary comparison in the participants and time window defined for that analysis.

They do not establish the size or persistence of any effect after Week 72, in the extension, or in groups not represented by the trial population. They do not determine how an individual participant will respond. The posted outcomes also do not establish comparative differences among the three doses, because direct dose-to-dose testing is not reported. The general pattern of secondary results provides additional context but does not replace the primary endpoint or resolve questions about multiplicity.

Statistical evidence against a null difference is not the same as evidence that a difference is clinically important. The registry record does not provide a threshold for clinical importance in the outcome description. Nor should these results be treated as a complete account of benefits and harms: safety figures shown are selected counts, and several secondary outcomes have no numerical results reported in the registry record. Overall interpretation depends on the trial’s population, follow-up, analysis assumptions, missing-data handling, and the completeness of outcome reporting.

18. Why This Trial Matters Statistically

Statistically, this record illustrates the distinction between a raw group summary and a model-based treatment contrast. The primary endpoint is evaluated with repeated-measures modeling, adjustments for specified factors, and an estimated covariance structure. That makes the reported least-squares mean differences the central quantities for interpreting the primary comparison, rather than an informal subtraction of displayed group values.

The record also makes clear why precision and multiplicity need separate consideration. The primary contrasts have confidence intervals that quantify uncertainty under the stated model, while the study includes several outcomes and analyses. The number of outcomes and analyses makes it important to know whether confirmatory claims were protected by an adjustment or testing hierarchy; that information is not reported in the registry record.

Finally, the gap between an outcome being listed and its numerical results being posted matters for evidence synthesis. The available results allow a focused reading of body weight and selected secondary outcomes, but do not provide a complete picture across all registered measures. Distinguishing reported model results, approximate unadjusted checks, planning illustrations, and missing registry entries helps prevent those different forms of evidence from being treated as interchangeable.

19. 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.

Interpretation is limited by details that are not reported in the registry record. The original sample-size justification, allocation ratio, full eligibility criteria, detailed missing-data methods, multiplicity strategy, and interim-analysis plans are not reported. The registry’s description identifies model terms and a variance-covariance structure, but does not provide model diagnostics or all sensitivity analyses.

Numerical results are unavailable for several registered secondary outcomes, and the posted secondary comparisons do not cover every dose for every endpoint. The waist circumference and HbA1c results shown omit a posted 36 mg comparison, while systolic blood pressure is presented for pooled doses. The registry record also does not provide the outcome results for the extension phase. As a result, the posted outcomes do not represent every registered measurement or the longer follow-up described for participants with prediabetes.

The safety information consists of selected serious adverse event counts, selected event terms, and deaths. It does not by itself provide exposure-adjusted event rates, a full adverse-event profile, or causal attribution. The statistical recalculations are approximate and unadjusted, and the planning figures are illustrations based on observed effects rather than the trial’s original design. These limitations should be kept distinct from the reported primary estimates, which are model-based results for the specified analysis population and time period.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities — NCT05869903.
• Registry record last updated 2026-08-14; status last verified 2026-07.
• Results first posted 2026-08-14.
• 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.

23. Record Summary

NCT05869903 is a Phase 3 randomized, double-blind, parallel-group study of once-daily oral orforglipron compared with placebo in adults with obesity or overweight and weight-related comorbidities. The primary treatment period lasted 72 weeks, with an extension described for participants with prediabetes. The primary endpoint is percent change in body weight from baseline to Week 72.

The registry reports mixed-model comparisons versus placebo for the 6 mg, 12 mg, and 36 mg groups. Posted secondary outcomes include waist circumference, pooled-dose systolic blood pressure, and HbA1c; numerical results for other listed outcomes are not reported in the registry record. The record is active, not recruiting, and lists a primary completion date of 2025-07-25.