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

JRCT ID: jRCT2031230136

Registered date:13/06/2023

Basic Information

• Recruitment status: Not Recruiting

Health condition(s) or Problem(s) studied

Obesity
Overweight
Overweight or Obesity

• Date of first enrollment: 18/07/2023
• Target sample size: 3000
• Countries of recruitment: Brazil,Japan,China,Japan,India,Japan,Korea, Republic of,Japan,Puerto Rico,Japan,Slovakia,Japan,Spain,Japan,Taiwan,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

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

Outcome(s)

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Masaki Takeshi
• Secondary ID(s): NCT05869903