A Study of Once-Daily Oral Orforglipron (LY3502970) in Japanese Adult Participants With Obesity Disease

Sponsor
Eli Lilly and Company
Study ID
NCT05931380
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Orforglipron — DRUG
    Administered orally
  • Placebo — DRUG
    Administered orally

Study Details

The main purpose of this study is to investigate the efficacy and safety of oral orforglipron in participants with obesity disease with obesity-related health problems.

Key Dates

First listed
Jul 5, 2023
Start date
Jul 31, 2023
Status verified
Jun 2026
Primary completion
Jun 19, 2025
Completion
Jun 19, 2025

Study Design

Enrollment
238 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo QD
    Participants received matching placebo capsule orally once daily (QD). Treatment was initiated with placebo corresponding to 1 mg equivalent to Orforglipron, with dose escalation every 4 weeks to maintain blinding, and was continued through Week 72, unless dose interruption or modification was required. Treatment was administered as an adjunct to a reduced-calorie diet and increased physical activity.
  • Experimental: 6 mg Orforglipron QD
    Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 6 mg, which was maintained through Week 72, unless dose interruption or modification was required. Treatment was administered as an adjunct to a reduced-calorie diet and increased physical activity.
  • Experimental: 12 mg Orforglipron QD
    Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 12 mg, which was maintained through Week 72, unless dose interruption or modification was required. Treatment was administered as an adjunct to a reduced-calorie diet and increased physical activity.
  • Experimental: 36 mg Orforglipron QD
    Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 36 mg, which was maintained through Week 72, unless dose interruption or modification was required. Treatment was administered as an adjunct to a reduced-calorie diet and increased physical activity.

Primary Outcome Measure

Percent Change From Baseline in Body Weight at Week 72 [ Time Frame: Baseline, Week 72 ]

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