Trial · Interventional

CompletedPhase 2Results postedRegistry data

A Study of LY3502970 in Participants With Obesity or Overweight With Weight-related Comorbidities

NCTNCT05051579Other id18210Other idJ2A-MC-GZGIOther id2021-002805-88

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 2
Enrollment: 272 participants (actual)
Sponsor: Eli Lilly and Company · Industry
Design: Randomized · Double masking
Countries: 4 countries
United States, Canada, Hungary, Puerto Rico
Start: 29 Sept 2021
Primary completion: 25 Aug 2022
Completion: 22 Nov 2022
First posted: 21 Sept 2021
Last update posted: 13 Sept 2023
Conditions: Obesity · Overweight and Obesity

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202120222023

Ph 2
A Study of LY3502970 in Participants With Obesity or Overweight With Weight-related Comorbidities
NCT05051579
29 Sept 2021 to 22 Nov 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The main purpose of the study was to assess the effect of LY3502970 in participants who have obesity or are overweight.

Interventions

LY3502970Drug
PlaceboDrug

Arms7

Experimental
12 milligram (mg) LY3502970
Participants received maintenance dose 12 mg with dose escalation starting from 3 mg,6 mg and then 12 mg LY3502970 administered orally once daily until 36 weeks.
Experimental
24 mg LY3502970
Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally once daily until 36 weeks.
Experimental
36 mg-1 LY3502970
Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 administered orally once daily until 36 weeks.
Experimental
36 mg-2 LY3502970
Participants received maintenance dose 36 mg with dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 administered orally once daily until 36 weeks.
Experimental
45 mg-1 LY3502970
Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally once daily until 36 weeks.
Experimental
45 mg-2 LY3502970
Participants received maintenance dose 45 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally once daily until 36 weeks.
Placebo comparator
Placebo
Participants received placebo administered orally once daily until 36 weeks.

Primary outcomes1

Outcomes the sponsor listed as primary.

Percent Change From Baseline in Body Weight in LY3502970 and Placebo
Time frame · Baseline, Week 26
Registry description
Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.

Secondary outcomes(11)

Percent Change From Baseline in Body Weight in LY3502970 and Placebo
Time frame · Baseline, Week 36
Registry description
LS mean was determined by MMRM model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.
Change From Baseline in Body Weight in LY3502970 and Placebo
Time frame · Baseline, Week 26
Registry description
LS mean was determined by MMRM model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.
Change From Baseline in Body Weight in LY3502970 and Placebo
Time frame · Baseline, Week 36
Registry description
LS mean was determined by MMRM model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.
Change From Baseline in Waist Circumference in LY3502970 and Placebo
Time frame · Baseline, Week 26
Registry description
LS mean was determined by MMRM model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.
Change From Baseline in Waist Circumference in LY3502970 and Placebo
Time frame · Baseline, Week 36
Registry description
LS mean was determined by MMRM model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.
Change From Baseline in BMI in LY3502970 and Placebo
Time frame · Baseline, Week 26
Registry description
LS mean was determined by MMRM model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.
Change From Baseline in BMI in LY3502970 and Placebo
Time frame · Baseline, Week 36
Registry description
LS mean was determined by MMRM model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.
Percentage of Participants With >=5% Body Weight Loss
Time frame · Week 26
Registry description
Percentage of participants with \>=5% body weight loss was reported.
Percentage of Participants With >=10% Body Weight Loss
Time frame · Week 26
Registry description
Percentage of participants with \>=10% body weight loss was reported.
Percentage of Participants With >=5% Body Weight Loss
Time frame · Week 36
Registry description
Percentage of participants with \>=5% body weight loss was reported.
Percentage of Participants With >=10% Body Weight Loss
Time frame · Week 36
Registry description
Percentage of participants with \>=10% body weight loss was reported.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· Baseline, Week 26

Percent Change From Baseline in Body Weight in LY3502970 and Placebo

Group	Value (Percent change)	Spread
12 mg LY3502970	-8.6	0.85
24 mg LY3502970	-11.2	0.82
36 mg LY3502970	-12.3	0.77
45 mg LY3502970	-12.6	0.75
Placebo	-2.0	0.81

Secondary and other outcome results(7)

Secondary outcomeLeast squares mean· Baseline, Week 36

Percent Change From Baseline in Body Weight in LY3502970 and Placebo

Group	Value (Percent change)	Spread
12 mg LY3502970	-9.4	1.05
24 mg LY3502970	-12.5	1.01
36 mg LY3502970	-13.5	0.95
45 mg LY3502970	-14.7	0.94
Placebo	-2.3	1.00

Secondary outcomeLeast squares mean· Baseline, Week 26

Change From Baseline in Body Weight in LY3502970 and Placebo

Group	Value (kg)	Spread
12 mg LY3502970	-9.0	0.90
24 mg LY3502970	-12.3	0.86
36 mg LY3502970	-12.9	0.82
45 mg LY3502970	-13.3	0.79
Placebo	-2.1	0.86

Secondary outcomeLeast squares mean· Baseline, Week 36

Change From Baseline in Body Weight in LY3502970 and Placebo

Group	Value (kg)	Spread
12 mg LY3502970	-9.8	1.10
24 mg LY3502970	-13.6	1.06
36 mg LY3502970	-14.2	1.00
45 mg LY3502970	-15.4	0.98
Placebo	-2.4	1.05

Secondary outcomeLeast squares mean· Baseline, Week 26

Change From Baseline in Waist Circumference in LY3502970 and Placebo

Group	Value (centimeter (cm))	Spread
12 mg LY3502970	-8.0	1.03
24 mg LY3502970	-8.8	1.00
36 mg LY3502970	-10.1	0.94
45 mg LY3502970	-12.2	0.93
Placebo	-3.6	0.99

Secondary outcomeLeast squares mean· Baseline, Week 36

Change From Baseline in Waist Circumference in LY3502970 and Placebo

Group	Value (cm)	Spread
12 mg LY3502970	-9.6	1.18
24 mg LY3502970	-11.2	1.15
36 mg LY3502970	-10.6	1.06
45 mg LY3502970	-13.6	1.07
Placebo	-4.0	1.12

Secondary outcomeLeast squares mean· Baseline, Week 26

Change From Baseline in BMI in LY3502970 and Placebo

Group	Value (kilograms per meter square (kg/m^2))	Spread
12 mg LY3502970	-3.2	0.31
24 mg LY3502970	-4.2	0.30
36 mg LY3502970	-4.6	0.28
45 mg LY3502970	-4.7	0.27
Placebo	-0.8	0.29

Secondary outcomeLeast squares mean· Baseline, Week 36

Change From Baseline in BMI in LY3502970 and Placebo

Group	Value (kg/m^2)	Spread
12 mg LY3502970	-3.4	0.38
24 mg LY3502970	-4.7	0.36
36 mg LY3502970	-5.0	0.34
45 mg LY3502970	-5.5	0.34
Placebo	-0.9	0.36

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
12 mg LY3502970Participants received maintenance dose 12 mg with dose escalation starting from 3 mg,6 mg and then 12 mg LY3502970 administered orally once daily until 36 weeks.	0 / 50	0 / 50	35 / 50
24 mg LY3502970Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally once daily until 36 weeks.	0 / 53	2 / 53	46 / 53
36 Mg-1 LY3502970Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 administered orally once daily until 36 weeks.	0 / 29	0 / 29	23 / 29
36 Mg-2 LY3502970Participants received maintenance dose 36 mg with dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 administered orally once daily until 36 weeks.	0 / 29	3 / 29	25 / 29
45 Mg-1 LY3502970Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally once daily until 36 weeks.	0 / 31	2 / 31	26 / 31
45 Mg-2 LY3502970Participants received maintenance dose 45 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally once daily until 36 weeks.	0 / 30	0 / 30	24 / 30
PlaceboParticipants received placebo administered orally once daily until 36 weeks.	0 / 50	0 / 50	27 / 50

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2025

8 results

Treatment with orforglipron, an oral glucagon like peptide-1 receptor agonist, is associated with improvements of CV risk biomarkers in participants with type 2 diabetes or obesity without diabetes.

Wharton et al. 2025Cardiovascular diabetologycited by 16

PMID 40481478PMC12142847DOI 10.1186/s12933-025-02781-xPUB-40481478

CC BY8 results

Download PDF See results (8)

Indexing hint: Randomized controlled trial · 2023

6 results

Daily Oral GLP-1 Receptor Agonist Orforglipron for Adults with Obesity.

Wharton et al. 2023The New England journal of medicinecited by 360

PMID 37351564DOI 10.1056/nejmoa2302392PUB-37351564

Full text at the publisher6 results

Publisher page See results (6)

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 75 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Have a body mass index (BMI) of ≥30-kilogram square meter (kg/m²) * Have a BMI ≥27 kg/m² and \<30 kg/m² with at least 1 of the following weight-related comorbidities eg; \[Have hypertension, or dyslipidemia, cardiovascular disease\] * Have had a stable body weight for the 3 months prior to randomization (not more than 5% body weight gain and/or loss) Exclusion Criteria: * Have any prior diagnosis of diabetes * Have a prior or planned surgical treatment for obesity * Have obesity induced by other endocrinological disorders or diagnosed monogenetic or syndromic forms of obesity * Have renal impairment measured as estimated glomerular filtration rate (eGFR) \<30 milliliter (mL)/minute (min)/1.73 m² * Have a history of acute chronic pancreatitis * Have a history of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder (for example, schizophrenia, bipolar disorder, or other serious mood or anxiety disorder) within the last 2 years Note: Participants with MDD or generalized anxiety disorder whose disease state is considered stable for the past 2 years and expected to remain stable throughout the course of the study, may be considered for inclusion if they are not on excluded medications. Within 3 months prior to screening: * Have poorly controlled hypertension * Have history of acute myocardial infarction * Have history of cerebrovascular accident (stroke) * Had hospitalization due to congestive heart failure (CHF) * Have cancer * Have human immunodeficiency virus (HIV) and/or positive HIV antibodies historically or at screening * Have hepatitis B and/or positive hepatitis B surface antigen

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