A Study of Orforglipron in Adult Participants With Obesity or Overweight and Type 2 Diabetes

Conditions

• Obesity
• Overweight
• Type 2 Diabetes

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

This study will investigate the safety and efficacy of once daily oral treatment with orforglipron compared with placebo on body weight in adult participants with obesity or overweight and type 2 diabetes. The study will last about 77 weeks and may include up to 22 visits.

Key Dates

First listed

May 24, 2023

Start date

Jun 5, 2023

Status verified

Sep 2026

Primary completion

Aug 8, 2025

Completion

Aug 8, 2025

Study Design

Enrollment

1,613 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo
  Participants received matching placebo capsule orally once daily (QD). Treatment was initiated with placebo corresponding to 1 milligram (mg) equivalent to Orforglipron, with dose escalation every 4 weeks to maintain blinding, and was continued through Week 72, unless dose modification was required.
• 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 modification was required.
• 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 modification was required.
• 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 modification was required.

Primary Outcome Measure

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

Locations (37)

Related coverage on Hipa.ai

• Orforglipron cuts body weight in Phase 3 diabetes trial
  Orforglipron · Sep 4, 2026 · ClinicalTrials.gov
• Orforglipron Phase 3 Trial for Obesity and Type 2 Diabetes Completes Primary…
  Orforglipron · Aug 8, 2025 · ClinicalTrials.gov

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