Phase 1 · Orforglipron

NCT05936138 trial results

A Phase 1, Parallel, Single-Dose, Open-Label, Single-Period Study of LY3502970 in Participants With Normal Renal Function and Participants With Renal Impairment

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-∞) of LY3502970 (nanogram*hour per milliliter (ng*hr/mL)), Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdose. LY3502970 (Normal Renal Function): 113; LY3502970 (Severe Renal Impairment): 167; LY3502970 (End-Stage Renal Disease): 108.

Participants
24
Status
completed
Completed
2024-04-11
Sponsor
Eli Lilly and Company

As posted on ClinicalTrials.gov (NCT05936138), updated at source Jun 9, 2026. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NCT05936138 measured first

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-∞) of LY3502970nanogram*hour per milliliter (ng*hr/mL) · Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdose · geometric mean
LY3502970 (Normal Renal Function)n=9LY3502970 (Severe Renal Impairment)n=5LY3502970 (End-Stage Renal Disease)n=7
113(32.1)167(48.6)108(87.8)
PK: Area Under the Concentration Versus Time Curve From Time Zero to Last Time Point (AUC0-tlast) of LY3502970ng*hr/mL · Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdose · geometric mean
LY3502970 (Normal Renal Function)n=9LY3502970 (Severe Renal Impairment)n=5LY3502970 (End-Stage Renal Disease)n=7
98.9(32.9)120(48.9)90.2(79.7)
PK: Maximum Observed Concentration (Cmax) of LY3502970nanogram per millilitre (ng/mL) · Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdose · geometric mean
LY3502970 (Normal Renal Function)n=9LY3502970 (Severe Renal Impairment)n=5LY3502970 (End-Stage Renal Disease)n=7
5.01(20.7)6.01(54.9)4.29(67.3)
Side effects by arm

Side effects in NCT05936138

Percent of participants affected, Baseline through follow-up (Up to 12 Days). The most common events the registry lists.

EventLY3502970 (Normal Renal Function)LY3502970 (Severe Renal Impairment)LY3502970 (End-Stage Renal Disease)
Any serious event0%0%0%
Haemodialysis0%0%62.5%
Nausea0%16.7%12.5%
Vomiting0%16.7%12.5%
Amylase increased0%16.7%0%
Lipase increased0%16.7%0%
Hypoglycaemia0%16.7%0%
Diarrhoea0%0%12.5%
The trial

How NCT05936138 was run

The main purpose of this study is to assess the amount of study drug (LY3502970) that reaches the bloodstream and the time it takes for the body to get rid of it when given to participants with renal (kidney) impairment compared to participants with normal renal function. The safety and tolerability of LY3502970 will also be evaluated in these participants. The study will last up to 6 weeks including screening period.

  • LY3502970 (Normal Renal Function): A single oral dose of 1 milligram (mg) LY3502970 was administered to participants with normal renal function \[defined as an estimated glomerular filtration rate (eGFR: ≥ 90 milliliters per minute (mL/min), and without a diagnosis of type 2 diabetes mellitus (T2D)\] on day 1.
  • LY3502970 (Severe Renal Impairment): A single oral dose of 1 mg LY3502970 was administered to participants with severe renal function \[defined as an eGFR: 15-29 mL/min and not requiring hemodialysis, with a diagnosis of T2D\] on day 1.
  • LY3502970 (End-Stage Renal Disease): A single oral dose of 1 mg LY3502970 was administered to participants with end stage renal disease \[defined as an eGFR: less than 15 mL/min or requiring hemodialysis, with a diagnosis of T2D\] on day 1.
Who could join the trial

Inclusion Criteria: * Have a body mass index within the range 18.5 to 42.0 kilograms per meter squared (kg/m²), inclusive. * Men and women who agree to use highly effective or effective methods of contraception may participate in this trial. Participants with Normal Renal Function: * Healthy males or females as determined by medical history, physical examination, and other screening procedures, with normal renal function. Have estimated glomerular filtration rate (eGFR) of greater than or equal to 90 milliliter per minute (mL/min) Participants with Renal Impairment: * Severe renal impairment: Have eGFR of 15 to 29 mL/min and not requiring hemodialysis. * ESRD: Participants who have been on a stable hemodialysis schedule for at least 3 months prior to planned dosing. Exclusion Criteria: * Have a current, functioning organ transplant. Non-functional renal allografts may be allowed. * Regularly use known drugs of abuse or show positive findings on urinary drug screen that are not otherwise explained by permitted concomitant medications. * Have known allergies to LY3502970, related compounds, or any components of the formulation, or history of severe atopy. * Are lactating, pregnant, or intend to become pregnant, or to breastfeed during the study. * Have a history or presence of chronic or acute pancreatitis Participants with Renal Impairment: * Have hemoglobin \<8.5 g/dL. * Participants with Type 2 Diabetes Mellitus if they have taken any Glucagon-like Peptide-1 Receptor Agonists (GLP1-RA) or a Dipeptidyl Peptidase 4 (DPP4) inhibitor in the past 6 weeks or 5 half-lives prior to dosing, whichever is longer, prior to dosing on Day 1

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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