> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/trial/a-master-protocol-study-ly900038-of-multiple-intervention-4fb412a0-6f78-4d87-8cc3-1da7b8ea4edb
> Record changed: 2026-10-13

# A Master Protocol Study (LY900038) of Multiple Intervention-Specific-Appendices (ISAs) in Adult Participants With Obesity or Overweight

NCT06143956

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06143956)

Phase

Phase 2

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06143956)

Recruitment status

Recruiting

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06143956)

Participants

1,481

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06143956)

Lead sponsor

Eli Lilly and Company

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06143956)

Start date

2023-11-17

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06143956)

Number of sites

54

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06143956)

## Title and summary

**Summary**

The purpose of this Phase-2 chronic weight management master protocol (CWMM) is to create a framework to evaluate the safety and efficacy of various investigational interventions for chronic weight management with intervention-specific appendices (ISAs). The CWMM establishes entry criteria for newly enrolled participants across the master and the ISAs. The ISAs may start independently of other ISAs as interventions become available for clinical testing. The results for the CWMM screening record will be reported when all the ISA's complete.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06143956)

**Short title**

A Master Protocol Study (LY900038) of Multiple Intervention-Specific-Appendices (ISAs) in Adult Participants With Obesity or Overweight

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06143956)

**Official title**

A Master Protocol for a Randomized, Controlled, Clinical Trial of Multiple Interventions for Chronic Weight Management in Adult Participants With Obesity or Overweight

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06143956)

## Status and phase

**Registry reports results**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06143956)

**Listing at source**

Listed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06143956)

**Recruitment status**

Recruiting

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06143956)

**Phase**

Phase 2

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06143956)

**Study type**

Interventional

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06143956)

## Dates

**Completion date**

2028-02-01

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06143956)

**First posted**

2023-11-22

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06143956)

**Registry last updated**

2026-08-06

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06143956)

**Primary completion date**

2027-09-01

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06143956)

**Start date**

2023-11-17

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06143956)

## Size and sites

**Participants**

1,481

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06143956)

**Participant count basis**

Estimated

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06143956)

**Planned participants**

1,481

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06143956)

**Protocol amendments**

12

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06143956)

**Number of sites**

54

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06143956)

## Sponsor and oversight

**Data monitoring committee**

Yes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06143956)

**Registry sponsor category**

Industry

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06143956)

**Lead sponsor**

Eli Lilly and Company

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06143956)

**Source registry**

ClinicalTrials.gov

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06143956)

## Identifiers

**Registry ID**

NCT06143956

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06143956)

**ClinicalTrials.gov ID**

NCT06143956

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06143956)

**Registry record**

Open registry record

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06143956)

## Study design

**Allocation**

Randomised

**Model**

Parallel groups

**Purpose**

Screening

**Masking**

Double masking

**Masked roles**

Participants, Investigators

Sources for study design

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06143956)

## Outcomes

### Primary outcomes

1. Number of Participants Allocated to Each ISA  
Timeframe: Baseline to Week 6  
Each ISA will detail the intervention specific analysis.

Sources for outcomes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06143956)

## Eligibility

**Sex**

All

**Age groups**

Adults, Older adults

**Minimum age**

18 Years

**Maximum age**

75 Years

**Healthy volunteers**

No

### Inclusion criteria

- Have a body mass index (BMI)

  - ≥30 kilogram/square meter (kg/m²), or
  - ≥27 kg/m² and <30 kg/m², or with at least 1 weight-related comorbidity
- Have had a stable body weight for the 3 months prior to randomization (<5%) body weight gain and/or loss.

### Exclusion criteria

- Have a prior or planned surgical treatment for obesity, except prior liposuction or abdominoplasty, if performed >1 year prior to screening.
- Have type 1 diabetes mellitus, latent autoimmune diabetes in adults, or history of ketoacidosis or hyperosmolar coma.
- Have poorly controlled hypertension.
- Have signs and symptoms of any liver disease other than nonalcoholic fatty liver disease.
- Have any of the following cardiovascular conditions within 3 months prior to screening:

  - acute myocardial infarction
  - cerebrovascular accident (stroke)
  - unstable angina, or
  - hospitalization due to congestive heart failure.
- Have a history of symptomatic gallbladder disease within the past 2 years.
- Have a lifetime history of suicide attempts.

Sources for eligibility

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06143956)

## Sites

- The Institute for Liver Health II dba Arizona Clinical Trials - MesaChandler, United StatesRecruiting
- HOPE Research InstitutePhoenix, United StatesCompleted
- Headlands Research - ScottsdaleScottsdale, United StatesRecruiting
- The Institute for Liver Health II dba Arizona Liver Health-TucsonTucson, United StatesRecruiting
- NorCal Medical Research, IncGreenbrae, United StatesRecruiting
- Velocity Clinical Research, Huntington ParkHuntington Park, United StatesRecruiting
- Peninsula Research AssociatesRolling Hills Estates, United StatesRecruiting
- Diablo Clinical Research, Inc.Walnut Creek, United StatesRecruiting
- Stamford Therapeutics ConsortiumStamford, United StatesRecruiting
- Northeast Research Institute (NERI)Fleming Island, United StatesCompleted
- New Horizon Research CenterMiami, United StatesRecruiting
- Indago Research & Health Center, IncMiami Lakes, United StatesRecruiting
- Suncoast Clinical Research, Inc.New Port Richey, United StatesRecruiting
- Charter Research - Winter ParkOrlando, United StatesRecruiting
- Charter Research - Lady LakeThe Villages, United StatesRecruiting
- Pacific Diabetes & Endocrine CenterHonolulu, United StatesCompleted
- Medical Research PartnersAmmon, United StatesRecruiting
- Great Lakes Clinical Trials - RavenswoodChicago, United StatesActive, not recruiting
- Great Lakes Clinical Trials - RavenswoodChicago, United StatesRecruiting
- NorthShore University Health SystemSkokie, United StatesActive, not recruiting
- Iowa Diabetes and Endocrinology Research CenterWest Des Moines, United StatesRecruiting
- Cotton O'Neil Diabetes & EndocrinologyTopeka, United StatesRecruiting
- Monroe Biomedical Research - LouisvilleLouisville, United StatesRecruiting
- KnownwellNeedham, United StatesRecruiting
- Lucida Clinical TrialsNew Bedford, United StatesRecruiting

And 29 more, listed on the interactive page.

Sources for sites

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06143956)

## References

### Other registry identifiers

- W8M-MC-CWMM

Sources for references

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06143956)

## Related records

### Drugs (4)

- [Eloralintide](https://trialight.com/data/asset/eloralintide-ccf70d16-4bb8-42b3-b3e3-491d8fbd44a8.md)
- [Macupatide](https://trialight.com/data/asset/macupatide-7e6f968a-8604-4cfa-be10-40ec1632a4c9.md)
- [Mazdutide](https://trialight.com/data/asset/mazdutide-e5f082bd-5031-49c0-81ec-410796ee2192.md)
- [Tirzepatide](https://trialight.com/data/asset/tirzepatide-eed85871-eb9c-4712-9102-badfdd99a720.md)

### Lead sponsors (1)

- [Eli Lilly and Company](https://trialight.com/data/company/eli-lilly-and-company-9da7efcc-bafe-4b95-b30b-e87a97770db7.md)

### Conditions (1)

- [Obesity disorder](https://trialight.com/data/condition/obesity-disorder-f3b57dc0-68ac-555c-8f13-0d81e595d9cb.md) Primary condition

### Targets (2)

- [GIPR](https://trialight.com/data/target/gipr-5b65dd73-9875-5aca-be7a-5469a7290f0c.md)
- [GLP1R](https://trialight.com/data/target/glp1r-c31cc749-2d8a-54a9-9dab-84f5ee5d1742.md)

---

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