Trial · Interventional

CompletedPhase 2Results postedRegistry data

A Study of LY3437943 in Participants Who Have Obesity or Are Overweight

NCTNCT04881760Other id18122Other idJ1I-MC-GZBF

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 2
Enrollment: 338 participants (actual)
Sponsor: Eli Lilly and Company · Industry
Design: Randomized · Double masking
Countries: 2 countries
United States, Puerto Rico
Start: 20 May 2021
Primary completion: 16 May 2022
Completion: 22 Nov 2022
First posted: 11 May 2021
Last update posted: 13 Sept 2023
Conditions: Obesity · Overweight

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 LY3437943 in Participants Who Have Obesity or Are Overweight
NCT04881760
20 May 2021 to 22 Nov 2022

Registry summary

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

This is a study of LY3437943 in participants who have obesity or are overweight. The main purpose is to learn more about how LY3437943 affects body weight loss. The study will last about 18 months and may include up to 18 visits.

Interventions

LY3437943Drug
PlaceboDrug

Arms7

Placebo comparator
Placebo
Participants received placebo matched to LY3437943 administered as subcutaneous (SC) injection once-weekly (QW).
Experimental
1 milligram (mg) LY3437943
Participants received 1 mg LY3437943 administered as SC injection QW.
Experimental
4 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
Experimental
4 mg LY3437943
Participants received 4 mg LY3437943 administered as SC injection QW.
Experimental
8 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
Experimental
8 mg LY3437943 (4 mg)
Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.
Experimental
12 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, 8 mg LY3437943 and then 12 mg LY3437943 administered as SC injection QW.

Primary outcomes1

Outcomes the sponsor listed as primary.

Mean Percent Change From Baseline in Body Weight
Time frame · Baseline, Week 24
Registry description
Least squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) for post-baseline measures: Variable = Treatment\*Time + Baseline BMI (\< 36kg/m2 vs. \>=36 kg/m2)\*Time + Sex (Female vs. Male)\*Time + Baseline\*Time.

Secondary outcomes(13)

Mean Percent Change From Baseline in Body Weight
Time frame · Baseline, Week 48
Registry description
LS means were calculated using a MMRM model for post-baseline measures: Variable = Treatment\*Time + Baseline BMI (\< 36kg/m2 vs. \>=36 kg/m2)\*Time + Sex (Female vs. Male)\*Time + Baseline\*Time.
Percentage of Participants Who Achieve ≥ 5% Body Weight Reduction
Time frame · Week 24
Registry description
Percentage of participants who achieve ≥ 5% body weight reduction in LY3437943 relative to placebo. Estimated percentage was determined by logistic regression model with an intercept term, treatment group, baseline BMI stratum \[\<36 kilograms per square meter (kg/m2), ≥36 kg/m2\] and sex \[female, male\] as fixed effects, and baseline body weight as a covariate.
Percentage of Participants Who Achieve ≥ 5% Body Weight Reduction
Time frame · Week 48
Registry description
Percentage of participants who achieve ≥ 5% body weight reduction in LY3437943 relative to placebo. Estimated percentage was determined by logistic regression model with an intercept term, treatment group, baseline BMI stratum \[\<36 kg/m2, ≥36 kg/m2\] and sex \[female, male\] as fixed effects, and baseline body weight as a covariate.
Percentage of Participants Who Achieve ≥ 10% Body Weight Reduction
Time frame · Week 24
Registry description
Percentage of participants who achieve ≥ 10% body weight reduction in LY3437943 relative to placebo. Estimated percentage was determined by logistic regression model with an intercept term, treatment group, baseline BMI stratum \[\<36 kg/m2, ≥36 kg/m2\] and sex \[female, male\] as fixed effects, and baseline body weight as a covariate.
Percentage of Participants Who Achieve ≥ 10% Body Weight Reduction
Time frame · Week 48
Registry description
Percentage of participants who achieve ≥ 10% body weight reduction in LY3437943 relative to placebo. Estimated percentage was determined by logistic regression model with an intercept term, treatment group, baseline BMI stratum \[\<36 kg/m2, ≥36 kg/m2\] and sex \[female, male\] as fixed effects, and baseline body weight as a covariate.
Percentage of Participants Who Achieve ≥ 15% Body Weight Reduction
Time frame · Week 24
Registry description
Percentage of participants who achieve ≥ 15% body weight reduction in LY3437943 relative to placebo. Estimated percentage was determined by logistic regression model with an intercept term, treatment group, baseline BMI stratum \[\<36 kg/m2, ≥36 kg/m2\] and sex \[female, male\] as fixed effects, and baseline body weight as a covariate.
Percentage of Participants Who Achieve ≥ 15% Body Weight Reduction
Time frame · Week 48
Registry description
Percentage of participants who achieve ≥ 15% body weight reduction in LY3437943 relative to placebo. Estimated percentage was determined by logistic regression model with an intercept term, treatment group, baseline BMI stratum \[\<36 kg/m2, ≥36 kg/m2\] and sex \[female, male\] as fixed effects, and baseline body weight as a covariate.
Mean Change From Baseline in Body Weight
Time frame · Baseline, Week 24
Registry description
LS means were calculated using a MMRM model for post-baseline measures: Variable = Treatment\*Time + Baseline BMI (\< 36kg/m2 vs. \>=36 kg/m2)\*Time + Sex (Female vs. Male)\*Time + Baseline\*Time.
Mean Change From Baseline in Body Weight
Time frame · Baseline, Week 48
Registry description
LS means were calculated using a MMRM model for post-baseline measures: Variable = Treatment\*Time + Baseline BMI (\< 36kg/m2 vs. \>=36 kg/m2)\*Time + Sex (Female vs. Male)\*Time + Baseline\*Time.
Mean Change From Baseline in BMI
Time frame · Baseline, Week 24
Registry description
LS means were calculated using a MMRM model for post-baseline measures: Variable = Treatment\*Time + Baseline BMI (\< 36kg/m2 vs. \>=36 kg/m2)\*Time + Sex (Female vs. Male)\*Time + Baseline\*Time.
Mean Change From Baseline in BMI
Time frame · Baseline, Week 48
Registry description
LS means were calculated using a MMRM model for post-baseline measures: Variable = Treatment\*Time + Baseline BMI (\< 36kg/m2 vs. \>=36 kg/m2)\*Time + Sex (Female vs. Male)\*Time + Baseline\*Time.
Mean Change From Baseline in Waist Circumference
Time frame · Baseline, Week 24
Registry description
LS means were calculated using a MMRM model for post-baseline measures: Variable = Treatment\*Time + Baseline BMI (\< 36kg/m2 vs. \>=36 kg/m2)\*Time + Sex (Female vs. Male)\*Time + Baseline\*Time.
Mean Change From Baseline in Waist Circumference
Time frame · Baseline, Week 48
Registry description
LS means were calculated using a MMRM model for post-baseline measures: Variable = Treatment\*Time + Baseline BMI (\< 36kg/m2 vs. \>=36 kg/m2)\*Time + Sex (Female vs. Male)\*Time + Baseline\*Time.

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 24

Mean Percent Change From Baseline in Body Weight

Group	Value (percent change)	Spread
Placebo	-1.55	0.54
1 mg LY3437943	-7.18	0.67
4 mg LY3437943 (2 mg)	-12.00	0.71
4 mg LY3437943	-13.80	0.97
8 mg LY3437943 (2 mg)	-16.64	0.74
8 mg LY3437943 (4 mg)	-18.26	0.95
12 mg LY3437943 (2 mg)	-17.39	0.69

Secondary and other outcome results(7)

Secondary outcomeLeast squares mean· Baseline, Week 48

Mean Percent Change From Baseline in Body Weight

Group	Value (percent change)	Spread
Placebo	-2.11	0.73
1 mg LY3437943	-8.67	0.95
4 mg LY3437943 (2 mg)	-16.32	1.58
4 mg LY3437943	-17.83	1.53
8 mg LY3437943 (2 mg)	-21.72	1.41
8 mg LY3437943 (4 mg)	-23.88	1.51
12 mg LY3437943 (2 mg)	-24.22	1.24

Secondary outcomeNumber· Week 24

Percentage of Participants Who Achieve ≥ 5% Body Weight Reduction

Group	Value (percentage of participants)
Placebo	26
1 mg LY3437943	59
4 mg LY3437943 (2 mg)	87
4 mg LY3437943	94
8 mg LY3437943 (2 mg)	100
8 mg LY3437943 (4 mg)	100
12 mg LY3437943 (2 mg)	97

Secondary outcomeNumber· Week 48

Percentage of Participants Who Achieve ≥ 5% Body Weight Reduction

Group	Value (percentage of participants)
Placebo	27
1 mg LY3437943	64
4 mg LY3437943 (2 mg)	87
4 mg LY3437943	97
8 mg LY3437943 (2 mg)	100
8 mg LY3437943 (4 mg)	100
12 mg LY3437943 (2 mg)	100

Secondary outcomeNumber· Week 24

Percentage of Participants Who Achieve ≥ 10% Body Weight Reduction

Group	Value (percentage of participants)
Placebo	3
1 mg LY3437943	25
4 mg LY3437943 (2 mg)	59
4 mg LY3437943	72
8 mg LY3437943 (2 mg)	83
8 mg LY3437943 (4 mg)	94
12 mg LY3437943 (2 mg)	90

Secondary outcomeNumber· Week 48

Percentage of Participants Who Achieve ≥ 10% Body Weight Reduction

Group	Value (percentage of participants)
Placebo	9
1 mg LY3437943	27
4 mg LY3437943 (2 mg)	73
4 mg LY3437943	76
8 mg LY3437943 (2 mg)	90
8 mg LY3437943 (4 mg)	91
12 mg LY3437943 (2 mg)	93

Secondary outcomeNumber· Week 24

Percentage of Participants Who Achieve ≥ 15% Body Weight Reduction

Group	Value (percentage of participants)
Placebo	1
1 mg LY3437943	10
4 mg LY3437943 (2 mg)	29
4 mg LY3437943	44
8 mg LY3437943 (2 mg)	51
8 mg LY3437943 (4 mg)	68
12 mg LY3437943 (2 mg)	70

Secondary outcomeNumber· Week 48

Percentage of Participants Who Achieve ≥ 15% Body Weight Reduction

Group	Value (percentage of participants)
Placebo	2
1 mg LY3437943	16
4 mg LY3437943 (2 mg)	55
4 mg LY3437943	64
8 mg LY3437943 (2 mg)	73
8 mg LY3437943 (4 mg)	77
12 mg LY3437943 (2 mg)	83

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
PlaceboParticipants received placebo matched to LY3437943 administered as SC injection QW.	0 / 70	3 / 70	40 / 70
1 mg LY3437943Participants received 1 mg LY3437943 administered as SC injection QW.	0 / 69	3 / 69	46 / 69
4 mg LY3437943 (2 mg)Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.	0 / 33	0 / 33	22 / 33
4 mg LY3437943Participants received 4 mg LY3437943 administered as SC injection QW.	1 / 33	2 / 33	24 / 33
8 mg LY3437943 (2 mg)Participants received 2 mg LY343794 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.	0 / 35	1 / 35	26 / 35
8 mg LY3437943 (4 mg)Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.	0 / 35	2 / 35	31 / 35
12 mg LY3437943 (2 mg)Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, 8 mg LY3437943 and then 12 mg LY3437943 administered as SC injection QW.	0 / 62	2 / 62	52 / 62

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

Studies4

Studies that cite this trial.

Studies with results

3 studies on this page

PubMed tag: none · 2026

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Kanu et al. 2026Advances in therapycited by 2

PMID 41201783PMC12858465DOI 10.1007/s12325-025-03386-2PUB-41201783

Free to read · publisher termsCC BY-NC

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Retatrutide-Associated Improvements in Cardiovascular Risk Biomarkers in Adults With Obesity With or Without Type 2 Diabetes.

Ruotolo et al. 2026Diabetes, obesity & metabolismcited by 1

PMID 42608321PMC13646367DOI 10.1111/dom.71200PUB-42608321

Free to read · publisher termsCC BY-NC11 results

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Indexing hint: Randomized controlled trial · 2024

12 results

Triple hormone receptor agonist retatrutide for metabolic dysfunction-associated steatotic liver disease: a randomized phase 2a trial.

Sanyal et al. 2024Nature medicinecited by 228

PMID 38858523PMC11271400DOI 10.1038/s41591-024-03018-2PUB-38858523

CC BY12 results

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Indexing hint: Randomized controlled trial · 2023

20 results

Triple-Hormone-Receptor Agonist Retatrutide for Obesity - A Phase 2 Trial.

Jastreboff et al. 2023The New England journal of medicinecited by 826

PMID 37366315DOI 10.1056/nejmoa2301972PUB-37366315

Full text at the publisher20 results

Publisher page See results (20)

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: * Participants must have a Body Mass Index (BMI) ) ≥30 and ≤50 kilograms per square meter (kg/m²), or ≥27 kg/m² and \<30 kg/m², with at least one of the following comorbidities: hypertension, dyslipidemia, cardiovascular disease * Participants must be willing to learn how to self-inject study drug or receive an injection from a trained individual if visually impaired or with physical limitations, and follow study procedures for the duration of the study, including, but not limited to, follow lifestyle advice (for example, dietary changes and physical activity plan), maintain a study drug administration log, and complete required questionnaires Exclusion Criteria: * Participants must not have type 1 or type 2 diabetes mellitus * Participants must not have had an increase or decrease in body weight \> more than 5 kg (11 pounds) within the past 3 months * Participants must not have had surgery for obesity or plan to have such surgery during the study * Participants must not be using medications that promote weight loss or cause weight gain * Participants must not drink excessive amounts of alcohol (more than 14 units a week for women or more than 21 units a week for men) * Participants must not have used marijuana within the last 3 months. * Participants must not have heart attack, stroke, or hospitalization for congestive heart failure in the past 3 months * Participants must not have active cancer within the last 5 years * Participants must not have uncontrolled high blood pressure * Participants must not have liver disease other than non-alcoholic fatty liver disease * Participants must not have renal impairment with estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73 m2 * Participants must not have a history of acute or chronic pancreatitis symptomatic gallbladder disease or documented human immunodeficiency virus infection * Participants must not have a major problem with depression or other mental illness within the last 2 years * Participants must not have family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma (family is defined as a first degree relative) * Female participants must not be pregnant, breast-feeding, or intend to become pregnant or of childbearing potential and not using adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice)

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