The trial is taking place at:
H

Hospital Universitario Virgen de la Victoria | Cardiology Department

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A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities (ATTAIN-1)

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Lilly

Status and phase

Active, not recruiting
Phase 3

Conditions

Overweight or Obesity
Overweight
Obesity

Treatments

Drug: Placebo
Drug: Orforglipron

Study type

Interventional

Funder types

Industry

Identifiers

NCT05869903
2022-502839-19-00 (Other Identifier)
J2A-MC-GZGP (Other Identifier)
U1111-1289-8877 (Other Identifier)
18559

Details and patient eligibility

About

This study will investigate the efficacy and safety of once daily oral orforglipron in adult participants with obesity or overweight with weight-related comorbidities.

Enrollment

3,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

* Have a BMI * ≥30.0 kilogram/square meter (kg/m²), * ≥27.0 kg/m² and presence of at least 1 of the following weight-related comorbidities (treated or untreated) at screening: * Hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease (for example, ischemic cardiovascular disease, New York Heart Association Functional Class I-III heart failure). * Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.

Exclusion criteria

* Have Type 1 diabetes, Type 2 diabetes, or any other types of diabetes, history of ketoacidosis, or hyperosmolar state/coma * Have a self-reported change in body weight \>5 kg (11 pounds) within 90 days prior to screening. * Have family (first-degree relative) or personal history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia (MEN)2 syndrome. * Have had a history of chronic or acute pancreatitis.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

3,000 participants in 4 patient groups, including a placebo group

Orforglipron Dose 1
Experimental group
Description:
Participant will receive orforglipron administered orally.
Treatment:
Drug: Orforglipron
Orforglipron Dose 2
Experimental group
Description:
Participant will receive orforglipron administered orally.
Treatment:
Drug: Orforglipron
Orforglipron Dose 3
Experimental group
Description:
Participant will receive orforglipron administered orally.
Treatment:
Drug: Orforglipron
Placebo
Placebo Comparator group
Description:
Participants will be given placebo.
Treatment:
Drug: Placebo

Trial contacts and locations

136

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Central trial contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Data sourced from clinicaltrials.gov

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