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ObesityPhase 2NCT04881760

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

A Phase 2 study testing LY3437943 in people with Obesity and Overweight, run by Eli Lilly and Company at 28 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Obesity, Overweight
What is being tested?
LY3437943
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
338 participants
Where
28 sitesin 2 countries
Study dates
20 May 2021to 22 Nov 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 15Show fewer
  • 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)

Trial locations and contacts

28 sites in 2 countries.

28 sites in 2 countries

United States25 sites

  • Anaheim Clinical Trials, LLC

    Anaheim, California, 92801

  • Texas Diabetes & Endocrinology, P.A.

    Austin, Texas, 78731

  • StudyMetrix Research

    City of Saint Peters, Missouri, 63303

  • Dallas Diabetes Research Center

    Dallas, Texas, 75230

  • Valley Research

    Fresno, California, 93720

  • Juno Research

    Houston, Texas, 77054

  • Endocrine Ips, Pllc

    Houston, Texas, 77079

  • Velocity Clinical Research, Huntington Park

    Huntington Park, California, 90255

  • East Coast Institute for Research, LLC

    Jacksonville, Florida, 32216

  • New Phase Research and Development

    Knoxville, Tennessee, 37909

  • Velocity Clinical Research, Huntington Park

    Los Angeles, California, 90057

  • Tandem Clinical Research,LLC

    Marrero, Louisiana, 70072

  • Southern Endocrinology Associates

    Mesquite, Texas, 75149

  • Suncoast Clinical Research, Inc.

    New Port Richey, Florida, 34652

  • Intend Research, LLC

    Norman, Oklahoma, 73069

  • Allegheny Endocrinology Associates

    Pittsburgh, Pennsylvania, 15212

  • Amici Clinical Research LLC

    Raritan, New Jersey, 08869

  • Rainier Clinical Research Center

    Renton, Washington, 98057

  • Southern California Dermatology, Inc.

    Santa Ana, California, 92701

  • Perseverance Research Center

    Scottsdale, Arizona, 85254

  • Springfield Diabetes & Endocrine Center

    Springfield, Illinois, 62711

  • Cotton O'Neil Diabetes and Endocrinology Center

    Topeka, Kansas, 66606

  • Coastal Metabolic Research Centre

    Ventura, California, 93003

  • Diablo Clinical Research, Inc.

    Walnut Creek, California, 94598

  • Encore Medical Research - Weston

    Weston, Florida, 33331

Other trials in United States

Puerto Rico3 sites

  • Private Practice - Dr. Paola Mansilla-Letelier

    Guaynabo, 00970

  • GCM Medical Group, PSC - Hato Rey Site

    San Juan, 00917

  • San Juan City Hospital

    San Juan, 00935

Other trials in Puerto Rico

About this study

Official title: A Phase 2 Study of Once-Weekly LY3437943 Compared With Placebo in Participants Who Have Obesity or Are Overweight With Weight-Related Comorbidities

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.

Conditions
Obesity, Overweight
Being tested
LY3437943, Placebo
Keywords
Nutritional or Metabolism Disorder, Weight Loss, Overnutrition, Incretins, Hormones, Physiological Effects of Drugs
Medical subject headings
Obesity, Overweight, Metabolic Diseases, Weight Loss, Overnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LY3437943Drug

    Administered SC

  • PlaceboDrug

    Administered SC

Study groups in NCT04881760
Study groupRoleWhat they receive
PlaceboPlacebo comparatorParticipants received placebo matched to LY3437943 administered as subcutaneous (SC) injection once-weekly (QW).
Receives: Drug: Placebo
1 milligram (mg) LY3437943ExperimentalParticipants received 1 mg LY3437943 administered as SC injection QW.
Receives: Drug: LY3437943
4 mg LY3437943 (2 mg)ExperimentalParticipants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
Receives: Drug: LY3437943
4 mg LY3437943ExperimentalParticipants received 4 mg LY3437943 administered as SC injection QW.
Receives: Drug: LY3437943
8 mg LY3437943 (2 mg)ExperimentalParticipants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
Receives: Drug: LY3437943
8 mg LY3437943 (4 mg)ExperimentalParticipants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.
Receives: Drug: LY3437943
12 mg LY3437943 (2 mg)ExperimentalParticipants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, 8 mg LY3437943 and then 12 mg LY3437943 administered as SC injection QW.
Receives: Drug: LY3437943

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Percent Change From Baseline in Body Weight

    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.

    Measured: Baseline, Week 24

Secondary outcomes (13)

  1. Mean Percent Change From Baseline in Body Weight

    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.

    Measured: Baseline, Week 48

  2. Percentage of Participants Who Achieve ≥ 5% Body Weight Reduction

    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.

    Measured: Week 24

  3. Percentage of Participants Who Achieve ≥ 5% Body Weight Reduction

    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.

    Measured: Week 48

  4. Percentage of Participants Who Achieve ≥ 10% Body Weight Reduction

    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.

    Measured: Week 24

  5. Percentage of Participants Who Achieve ≥ 10% Body Weight Reduction

    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.

    Measured: Week 48

  6. Percentage of Participants Who Achieve ≥ 15% Body Weight Reduction

    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.

    Measured: Week 24

  7. Percentage of Participants Who Achieve ≥ 15% Body Weight Reduction

    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.

    Measured: Week 48

  8. Mean Change From Baseline in Body Weight

    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.

    Measured: Baseline, Week 24

  9. Mean Change From Baseline in Body Weight

    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.

    Measured: Baseline, Week 48

  10. Mean Change From Baseline in BMI

    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.

    Measured: Baseline, Week 24

  11. Mean Change From Baseline in BMI

    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.

    Measured: Baseline, Week 48

  12. Mean Change From Baseline in Waist Circumference

    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.

    Measured: Baseline, Week 24

  13. Mean Change From Baseline in Waist Circumference

    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.

    Measured: Baseline, Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2021
  2. Study start20 May 2021
  3. Primary completion16 May 2022
  4. Study completion22 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
338 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04881760
Sponsor's protocol ID
18122
Other IDs
J1I-MC-GZBF
Status last verified
Aug 2023
First submitted
10 May 2021
Last updated
13 Sep 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Publications

  • Ruotolo G, Harris C, Lin Y, Wilson JM, Pirro V, Duffin KL, Thomas MK, Hartman ML, Neill CO, Coskun T, Milicevic Z, Haupt A, Sattar N, Nicholls SJ. Retatrutide-Associated Improvements in Cardiovascular Risk Biomarkers in Adults With Obesity With or Without Type 2 Diabetes. Diabetes Obes Metab. 2026 Aug 17. doi: 10.1111/dom.71200. Online ahead of print.

    PubMed 42608321

  • Kanu C, Clucas C, Skalicky A, Samuelson A, Goetz I, Neff LM, Boye KS, Karn H. Development and Content Evaluation of the Eating Behavior and Appetite Questionnaire (EBAQ) for Individuals with Obesity. Adv Ther. 2026 Jan;43(1):150-164. doi: 10.1007/s12325-025-03386-2. Epub 2025 Nov 7.

    PubMed 41201783

  • Sanyal AJ, Kaplan LM, Frias JP, Brouwers B, Wu Q, Thomas MK, Harris C, Schloot NC, Du Y, Mather KJ, Haupt A, Hartman ML. Triple hormone receptor agonist retatrutide for metabolic dysfunction-associated steatotic liver disease: a randomized phase 2a trial. Nat Med. 2024 Jul;30(7):2037-2048. doi: 10.1038/s41591-024-03018-2. Epub 2024 Jun 10.

    PubMed 38858523

  • Jastreboff AM, Kaplan LM, Frias JP, Wu Q, Du Y, Gurbuz S, Coskun T, Haupt A, Milicevic Z, Hartman ML; Retatrutide Phase 2 Obesity Trial Investigators. Triple-Hormone-Receptor Agonist Retatrutide for Obesity - A Phase 2 Trial. N Engl J Med. 2023 Aug 10;389(6):514-526. doi: 10.1056/NEJMoa2301972. Epub 2023 Jun 26.

    PubMed 37366315

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LY3437943 in people with Obesity and Overweight, run by Eli Lilly and Company at 28 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Percent Change From Baseline in Body Weight (time frame: Baseline, Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04881760, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.

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