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

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05051579
• Collaborator: (none)
• Enrollment: 270
• Locations: 35
• Arms: 5
• Anticipated Duration (Months): 13.7
• Patients Per Site: 7.7
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Obesity; Overweight and Obesity	Drug: LY3502970; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 270 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase 2 Study of Once-Daily LY3502970 Compared With Placebo in Participants Who Have Obesity or Are Overweight With Weight-Related Comorbidities
• Actual Study Start Date: Sep 29, 2021
• Anticipated Primary Completion Date: Aug 26, 2022
• Anticipated Study Completion Date: Nov 21, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LY3502970 Dose 1 Participants will receive LY3502970 administered orally	Drug: LY3502970; Administered orally
Experimental: LY3502970 Dose 2 Participants will receive LY3502970 administered orally	Drug: LY3502970; Administered orally
Experimental: LY3502970 Dose 3 Participants will receive LY3502970 administered orally	Drug: LY3502970; Administered orally
Experimental: LY3502970 Dose 4 Participants will receive LY3502970 administered orally	Drug: LY3502970; Administered orally
Placebo Comparator: Placebo Placebo administered orally	Drug: Placebo; Administered orally

Outcome Measures

Primary Outcome Measures

1. Percent Change From Baseline in Body Weight [Baseline, Week 26]

   Percent Change From Baseline in Body Weight

Secondary Outcome Measures

1. Percent Change From Baseline in Body Weight [Baseline, Week 36]

   Percent Change From Baseline in Body Weight

2. Change From Baseline in Body Weight [Baseline, Week 26]

   Change From Baseline in Body Weight

3. Change From Baseline in Body Weight [Baseline, Week 36]

   Change From Baseline in Body Weight

4. Percentage of Participants Who Achieve ≥5% in Body Weight [Week 26]

   Percentage of Participants Who Achieve ≥5% in Body Weight

5. Percentage of Participants Who Achieve ≥5% in Body Weight [Week 36]

   Percentage of Participants Who Achieve ≥5% in Body Weight

6. Percentage of Participants Who Achieve ≥10% in Body Weight [Week 26]

   Percentage of Participants Who Achieve ≥10% in Body Weight

7. Percentage of Participants Who Achieve ≥10% in Body Weight [Week 36]

   Percentage of Participants Who Achieve ≥10% in Body Weight

8. Percent Change From Baseline in Body Mass Index (BMI) [Baseline, Week 26]

   Percent Change From Baseline in BMI

9. Percent Change From Baseline in BMI [Baseline, Week 36]

   Percent Change From Baseline in BMI

10. Change From Baseline in Waist Circumference [Baseline, Week 26]

    Change From Baseline in Waist Circumference

11. Change From Baseline in Waist Circumference [Baseline, Week 36]

    Change From Baseline in Waist Circumference

12. Pharmacokinetics (PK): Steady State Area Under the Concentration Curve (AUC) of LY3502970 [Baseline to Week 36]

    PK: Steady State AUC of LY3502970

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Anaheim Clinical Trials, LLC	Anaheim	California	United States	92801
2	John Muir Physician Network Research Center	Concord	California	United States	94520
3	NorCal Medical Research, Inc	Greenbrae	California	United States	94904
4	Valley Clinical Trials, Inc.	Northridge	California	United States	91325
5	Norcal Endocrinology & Internal Medicine	San Ramon	California	United States	94583
6	Elite Clinical Trials	Blackfoot	Idaho	United States	83221
7	Rocky Mountain Clinical Research	Idaho Falls	Idaho	United States	83404
8	StudyMetrix Research	Saint Peters	Missouri	United States	63303
9	Premier Research	Trenton	New Jersey	United States	08611
10	Lillestol Research	Fargo	North Dakota	United States	58104
11	Intend Research, LLC	Norman	Oklahoma	United States	73069
12	Capital Area Research, LLC	Camp Hill	Pennsylvania	United States	17011
13	Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair	Pittsburgh	Pennsylvania	United States	15243
14	Dallas Diabetes Research Center	Dallas	Texas	United States	75230
15	Diabetes and Thyroid Center of Fort Worth	Fort Worth	Texas	United States	76132
16	Texas Diabetes & Endocrinology, P.A.	Round Rock	Texas	United States	78681
17	National Clinical Research, Inc	Richmond	Virginia	United States	23294
18	St. Vincent Hospital d/b/a Prevea Health	Green Bay	Wisconsin	United States	54303
19	C-health Research	Calgary	Alberta	Canada	T2V 4J2
20	Wharton Medical Clinic	Hamilton	Ontario	Canada	L8L 5G8
21	Bluewater Clinical Research Group Inc.	Sarnia	Ontario	Canada	N7T 4X3
22	Centre Médical et Professionnel de l'Ouest de Portneuf	Saint Marc des Carrières	Quebec	Canada	G0A 4B0
23	Alpha Recherche Clinique	Quebec		Canada	G2J 0C4
24	ALPHA Recherche Clinique	Quebec		Canada	G3K 2P8
25	Studium Egeszseghaz Kft	Kalocsa	Bács-Kiskun	Hungary	6300
26	Bugát Pál Kórház	Gyongyos	Heves	Hungary	3200
27	DRC Gyógyszervizsgáló Központ	Balatonfüred	Veszprém	Hungary	8230
28	Kanizsai Dorottya Korhaz	Nagykanizsa	Zala	Hungary	8800
29	Szent Margit Rendelőintézet Nonprofit Kft	Budapest		Hungary	1032
30	Clinexpert Kft.	Budapest		Hungary	1033
31	TRANTOR'99 Bt. Anyagcsere Centrum	Budapest		Hungary	1213
32	Strazsahegy Medicina Bt.	Budapest		Hungary	H1171
33	Debreceni Egyetem Klinikai Kozpont	Debrecen		Hungary	4032
34	Puerto Rico Medical Research	Ponce		Puerto Rico	00717
35	Research and Cardiovascular Corp.	Ponce		Puerto Rico	00717

Sponsors and Collaborators

• Eli Lilly and Company

Investigators

• Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-5615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT05051579
• Other Study ID Numbers: 18210; J2A-MC-GZGI; 2021-002805-88
• First Posted: Sep 21, 2021
• Last Update Posted: Jun 9, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Obesity; Overweight

Study Results

No Results Posted as of Jun 9, 2022