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A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once-Daily Oral LY3502970 Compared With Placebo in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities (ATTAIN-1) (J2A-MC-GZGP)

A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities (J2A-MC-GZGP)

Masaki Takeshi

Eli Lilly Japan K.K.

5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo

LTG_CallCenter@lists.lilly.com

Trial Guide Call Center

Eli Lilly Japan K.K.

5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo

+81-120-023-812

LTG_CallCenter@lists.lilly.com

Not Recruiting

July. 18, 2023

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

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.

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.

Both

Obesity
Overweight
Overweight or Obesity

Drug: Orforglipron
Administered orally.
Other Name: LY3502970
Drug: Placebo
Administered orally.

Study Arms
Experimental: Orforglipron Dose 1
Participant will receive orforglipron administered orally.
Intervention: Drug: Orforglipron
Experimental: Orforglipron Dose 2
Participant will receive orforglipron administered orally.
Intervention: Drug: Orforglipron
Experimental: Orforglipron Dose 3
Participant will receive orforglipron administered orally.
Intervention: Drug: Orforglipron
Placebo Comparator: Placebo
Participants will be given placebo.
Intervention: Drug: Placebo

Mean Percent Change from Baseline in Body Weight [ Time Frame: Baseline to Week 72 ]

+81-3-3517-6688

May. 12, 2023

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.

Brazil/China/India/Korea, Republic of/Puerto Rico/Slovakia/Spain/Taiwan/United States